{
  "dataset": "SPF List UV filter database",
  "version": "2026.09",
  "generated": "2026-09-22",
  "license": "CC-BY-4.0",
  "source": "https://spflist.com/data/",
  "jurisdictions": ["us", "eu", "ca", "au", "jp"],
  "sources": [{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","title":"FDA OTC Monograph M020, Sunscreen Drug Products for Over-the-Counter Human Use","note":"The order that actually governs US sunscreens: the 1999 stayed monograph, deemed final by the CARES Act. Effective 9 August 2026."},{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf","title":"FDA proposed administrative order OTC000008, 24 September 2021","note":"Proposes that twelve of the filters are not GRASE for want of data, and that zinc oxide and titanium dioxide are. Never finalized."},{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/FinalAdministrativeOrderOTC000008-PABATrolamine.pdf","title":"FDA final administrative order OTC000008-1, issued 11 September 2026","note":"Determines PABA and trolamine salicylate not GRASE and removes them from M020, with effect from 11 September 2027."},{"url":"https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/OTC000039_Final_Administrative_Order.pdf","title":"FDA final administrative order OTC000039, 10 June 2026","note":"Adds bemotrizinol to M020 at up to 6%, effective 9 August 2026."},{"url":"https://www.federalregister.gov/d/2015-00002","title":"FDA, sunscreen Time and Extent Application feedback letters, 80 FR 892","note":"Tentatively classified six filters, including bisoctrizole and ethylhexyl triazone, as not GRASE for want of data. Never finalized."},{"url":"https://www.federalregister.gov/d/2015-03883","title":"FDA proposed order on ecamsule, 80 FR 10035","note":"Tentative determination that ecamsule up to 10% is not GRASE. Never finalized; ecamsule is sold in the US under new drug applications."},{"url":"https://www.federalregister.gov/d/2015-03884","title":"FDA proposed order on enzacamene, 80 FR 10026","note":"Tentative determination that enzacamene is not GRASE. Never finalized."},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518","title":"Annex VI to Regulation (EC) No 1223/2009, consolidated text of 18 May 2026","note":"The EU list of UV filters allowed in cosmetic products, with the maximum concentration and conditions for each."},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013R0344","title":"Commission Regulation (EU) No 344/2013","note":"Emptied Annex VI entry 1 and moved 4-aminobenzoic acid to the prohibited list, Annex II entry 167."},{"url":"https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R0996","title":"Commission Regulation (EU) 2024/996","note":"Deleted 4-methylbenzylidene camphor from Annex VI; off the market from 1 May 2026."},{"url":"https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng","title":"Health Canada, Primary Sunscreen Monograph, version of 27 February 2026","note":"Table 1 covers the two minerals as natural health product ingredients, Table 2 the organic filters as non-prescription drug ingredients."},{"url":"https://www.legislation.gov.au/F2026L00707/asmade/text","title":"Therapeutic Goods (Permissible Ingredients) Determination (No. 2) 2026","note":"Schedule 1 of the Australian instrument in force since 12 June 2026, which sets each sunscreen active's permitted concentration."},{"url":"https://www.mhlw.go.jp/content/001257665.pdf","title":"MHLW Standards for Cosmetics (Notification No. 331 of 2000), Appendix 4","note":"Japan's positive list of UV absorbers. A UV absorber that is not in Appendix 4 may not be used in a cosmetic at all."},{"url":"https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_129.pdf","title":"SCCS/1328/10, opinion on methylene bis-benzotriazolyl tetramethylbutylphenol (nano)","note":"Describes the filter's double absorption band, at about 305 nm and 350 nm, and how a micronized dispersion shifts it."},{"url":"https://doi.org/10.3390/cosmetics10040101","title":"Guerra-Tapia et al., \"Sunscreens: A Review of UV Filters\", Cosmetics 2023, 10, 101","note":"Peer-reviewed review giving the absorption maximum and band class of each approved UV filter."},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC13063171/","title":"HPLC study of avobenzone and tris-biphenyl triazine, PMC13063171","note":"Reports 310 nm for tris-biphenyl triazine in acetonitrile:isopropanol and states its UVB and UVA II coverage."},{"url":"https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_130.pdf","title":"SCCP/1166/08, opinion on diethylamino hydroxybenzoyl hexyl benzoate","note":"Gives the absorption spectrum: 356 nm in methanol, 358 nm in methanolic HCl."},{"url":"https://health.ec.europa.eu/document/download/a056c28e-9170-40c4-a9bd-e169e47a3a20_en?filename=sccs_o_215.pdf","title":"SCCS/1594/18, opinion on phenylene bis-diphenyltriazine","note":"Gives the absorption maximum, 329 nm at 10 µg/ml in dichloromethane."},{"url":"https://pubmed.ncbi.nlm.nih.gov/34643936/","title":"Marionnet et al., Photochem Photobiol Sci 2021;20:1475-86, on TriAsorB","note":"States that the filter is broad spectrum across UVB and UVA including long UVA, and also absorbs visible light."},{"url":"https://health.ec.europa.eu/document/download/d430932d-77a6-4fa7-957d-93b2e35e1a7b_en","title":"SCCS/1605/19, opinion on methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate","note":"Gives the absorption maximum, 385 nm."},{"url":"https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_058.pdf","title":"SCCP/1008/06, opinion on para-aminobenzoic acid","note":"Gives 289 nm in alcohol, 278 nm in water, and 300-305 nm for crystals deposited on skin."},{"url":"https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_136.pdf","title":"SCCS/1516/13, opinion on titanium dioxide (nano)","note":"Carries the extinction tables that show titanium dioxide's attenuation falling from 308 nm to 400 nm."},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC3781714/","title":"Smijs and Pavel, Nanotechnol Sci Appl 2011;4:95-112, on titanium dioxide and zinc oxide","note":"Compares the two minerals: titanium dioxide is primarily a UVB absorber, zinc oxide is the more efficient UVA absorber, with a wurtzite band gap of 3.22 eV."},{"url":"https://pmc.ncbi.nlm.nih.gov/articles/PMC7894303/","title":"Dumbuya et al., J Cosmet Dermatol 2021, on iron oxides and visible light","note":"Gives the attenuation range of yellow, red and black iron oxides across the visible spectrum."}],
  "records": [{"inci":"Butyl Methoxydibenzoylmethane","name":"Avobenzone","cas":"70356-09-1","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/avobenzone","spf_record":null,"aliases":["avobenzone","parsol 1789","bmdbm","escalol 517","4-tert-butyl-4'-methoxydibenzoylmethane","1-(4-tert-butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione"],"coverage":{"full":["UVA I","UVA II"],"partial":[],"visible":false,"centre":"UVA","centre_note":"only"},"lambda_max":null,"us":{"status":"proposed not GRASE","max_percent":3,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"Annex VI entry 8","max_percent":5,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"monograph","max_percent":3,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":5,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":10,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"One cap for all cosmetic types."}},{"inci":"Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine","name":"Bemotrizinol","cas":"187393-00-6","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/bemotrizinol","spf_record":null,"aliases":["bemotrizinol","tinosorb s","escalol s","anisotriazine","bis ethylhexyloxyphenol methoxyphenyl triazine","beomt"],"coverage":{"full":["UVB","UVA II","UVA I"],"partial":[],"visible":false,"centre":"Broad","centre_note":"spectrum"},"lambda_max":null,"us":{"status":"GRASE","max_percent":6,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/OTC000039_Final_Administrative_Order.pdf"],"read":"2026-09-22","verified":true,"note":"Final administrative order OTC000039, effective 9 August 2026 — the first sunscreen active added to the US monograph in about 25 years."},"eu":{"status":"Annex VI entry 25","max_percent":10,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"monograph","max_percent":6,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":3.0,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"3.0% rinse-off and leave-on; not permitted where the product may contact mucosa."}},{"inci":"Cinoxate","name":"Cinoxate","cas":"104-28-9","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/cinoxate","spf_record":null,"aliases":["cinoxate","2-ethoxyethyl p-methoxycinnamate","2-ethoxyethyl 4-methoxycinnamate","ethoxyethyl methoxycinnamate"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"weak"},"lambda_max":null,"us":{"status":"proposed not GRASE","max_percent":3,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"not in Annex VI","max_percent":null,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"monograph","max_percent":3,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":6,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":5.0,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"No upper limit for rinse-off products; 5.0% leave-on and on mucosa."}},{"inci":"Benzophenone-8","name":"Dioxybenzone","cas":"131-53-3","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/dioxybenzone","spf_record":null,"aliases":["dioxybenzone","benzophenone-8","bp-8","2,2'-dihydroxy-4-methoxybenzophenone","spectra-sorb uv 24"],"coverage":{"full":["UVB"],"partial":["UVA II"],"visible":false,"centre":"UVB","centre_note":"+ some UVA II"},"lambda_max":null,"us":{"status":"proposed not GRASE","max_percent":3,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"not in Annex VI","max_percent":null,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"monograph","max_percent":3,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":3,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"not permitted","max_percent":null,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the Appendix 4 positive list, and only listed UV absorbers may be used in Japanese cosmetics."}},{"inci":"Phenylbenzimidazole Sulfonic Acid","name":"Ensulizole","cas":"27503-81-7","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/ensulizole","spf_record":null,"aliases":["ensulizole","pbsa","eusolex 232","neo heliopan hydro","2-phenylbenzimidazole-5-sulfonic acid","2-phenyl-1h-benzimidazole-5-sulphonic acid","parsol hs"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"only"},"lambda_max":null,"us":{"status":"proposed not GRASE","max_percent":4,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"Annex VI entry 6","max_percent":8,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"As the acid; the potassium, sodium and triethanolamine salts are covered by the same entry."},"ca":{"status":"monograph","max_percent":4,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":4,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":3.0,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"3.0% rinse-off and leave-on; not permitted where the product may contact mucosa."}},{"inci":"Homosalate","name":"Homosalate","cas":"118-56-9","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/homosalate","spf_record":null,"aliases":["homosalate","homomenthyl salicylate","eusolex hms","3,3,5-trimethylcyclohexyl salicylate","hms","neo heliopan hms"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"only"},"lambda_max":null,"us":{"status":"proposed not GRASE","max_percent":15,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"Annex VI entry 3","max_percent":7.34,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"Face products only, excluding propellent sprays — cut from 10% by Regulation (EU) 2022/2195."},"ca":{"status":"monograph","max_percent":15,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":15,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true,"note":"Also permitted as an excipient. The TGA's July 2025 safety review recommended restricting homosalate and oxybenzone; that recommendation has not reached the Determination."},"jp":{"status":"Appendix 4 listed","max_percent":10,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"One cap for all cosmetic types."}},{"inci":"Menthyl Anthranilate","name":"Meradimate","cas":"134-09-8","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/meradimate","spf_record":null,"aliases":["meradimate","menthyl anthranilate","menthyl-2-aminobenzoate","neo heliopan ma","5-methyl-2-(1-methylethyl)cyclohexanol 2-aminobenzoate"],"coverage":{"full":[],"partial":["UVA II"],"visible":false,"centre":"UVA II","centre_note":"weak"},"lambda_max":null,"us":{"status":"proposed not GRASE","max_percent":5,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"not in Annex VI","max_percent":null,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"monograph","max_percent":5,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":5,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"not permitted","max_percent":null,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the Appendix 4 positive list, and only listed UV absorbers may be used in Japanese cosmetics."}},{"inci":"Ethylhexyl Methoxycinnamate","name":"Octinoxate","cas":"5466-77-3","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/octinoxate","spf_record":null,"aliases":["octinoxate","ethylhexyl methoxycinnamate","octyl methoxycinnamate","omc","2-ethylhexyl p-methoxycinnamate","parsol mcx","escalol 557","eusolex 2292","uvinul mc80","neo heliopan av"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"only"},"lambda_max":null,"us":{"status":"proposed not GRASE","max_percent":7.5,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"Annex VI entry 12","max_percent":10,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"monograph","max_percent":7.5,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":20,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"20% rinse-off and leave-on; 8.0% where the product may contact mucosa — the highest numeric cap in the appendix."}},{"inci":"Ethylhexyl Salicylate","name":"Octisalate","cas":"118-60-5","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/octisalate","spf_record":null,"aliases":["octisalate","ethylhexyl salicylate","octyl salicylate","2-ethylhexyl salicylate","neo heliopan os","escalol 587","eusolex os"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"weak"},"lambda_max":null,"us":{"status":"proposed not GRASE","max_percent":5,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"Annex VI entry 20","max_percent":5,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"monograph","max_percent":5,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":5,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":10,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"10% rinse-off and leave-on; 5.0% where the product may contact mucosa."}},{"inci":"Octocrylene","name":"Octocrylene","cas":"6197-30-4","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/octocrylene","spf_record":null,"aliases":["octocrylene","octocrilene","uvinul n 539 t","eusolex ocr","2-ethylhexyl 2-cyano-3,3-diphenylacrylate","neo heliopan 303","parsol 340"],"coverage":{"full":["UVB"],"partial":["UVA II"],"visible":false,"centre":"UVB","centre_note":"+ some UVA II","source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","note":"Bands placed from the 303 nm peak the review reports."},"lambda_max":{"nm":303,"source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","verified":true},"us":{"status":"proposed not GRASE","max_percent":10,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"Annex VI entry 10","max_percent":10,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"9% in propellant sprays, 10% in other products, per Regulation (EU) 2022/1176."},"ca":{"status":"monograph","max_percent":10,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":10,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"One cap for all cosmetic types."}},{"inci":"Benzophenone-3","name":"Oxybenzone","cas":"131-57-7","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/oxybenzone","spf_record":null,"aliases":["oxybenzone","benzophenone-3","bp-3","2-hydroxy-4-methoxybenzophenone","eusolex 4360","escalol 567","uvinul m 40","milestab 9"],"coverage":{"full":["UVB","UVA II"],"partial":["UVA I"],"visible":false,"centre":"Partial","centre_note":"UVB + UVA II"},"lambda_max":null,"us":{"status":"proposed not GRASE","max_percent":6,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"Annex VI entry 4","max_percent":6,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"6% in face, hand and lip products excluding sprays; 2.2% in body products including sprays; 0.5% where used only to protect the formulation. Products must be labeled “Contains Benzophenone-3”."},"ca":{"status":"monograph","max_percent":6,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true,"note":"The TGA's July 2025 safety review recommended restricting oxybenzone's permitted concentration; that recommendation has not reached the Determination."},"jp":{"status":"Appendix 4 listed","max_percent":5.0,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"No upper limit for rinse-off products; 5.0% leave-on and on mucosa."}},{"inci":"Ethylhexyl Dimethyl PABA","name":"Padimate O","cas":"21245-02-3","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/padimate-o","spf_record":null,"aliases":["padimate o","ethylhexyl dimethyl paba","octyl dimethyl paba","2-ethylhexyl p-dimethylaminobenzoate","escalol 507","eusolex 6007","od-paba","amerscreen p"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"only"},"lambda_max":null,"us":{"status":"proposed not GRASE","max_percent":8,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"Annex VI entry 21","max_percent":8,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"monograph","max_percent":8,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":8,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":10,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"10% rinse-off and leave-on; 7.0% where the product may contact mucosa."}},{"inci":"Benzophenone-4","name":"Sulisobenzone","cas":"4065-45-6","type":"organic","uv_filter":true,"page":"/conventional-sunscreens/sulisobenzone","spf_record":null,"aliases":["sulisobenzone","benzophenone-4","bp-4","benzophenone-5","sulisobenzone sodium","uvinul ms 40","2-hydroxy-4-methoxybenzophenone-5-sulfonic acid","hydroxymethoxybenzophenone sulfonic acid"],"coverage":{"full":["UVB"],"partial":["UVA II"],"visible":false,"centre":"UVB","centre_note":"+ some UVA II"},"lambda_max":null,"us":{"status":"proposed not GRASE","max_percent":10,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at this concentration and marketable today: the deemed final order keeps it on sale while the FDA's 2021 proposed order, which proposed it not GRASE for want of data, stays unfinalized."},"eu":{"status":"Annex VI entry 22","max_percent":5,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"As the acid; the same entry covers Benzophenone-5, the sodium salt."},"ca":{"status":"monograph","max_percent":10,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":10,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"10% rinse-off and leave-on, as total hydroxymethoxybenzophenone sulfonate; 0.10% where the product may contact mucosa."}},{"inci":"Titanium Dioxide","name":"Titanium Dioxide","cas":"13463-67-7","type":"mineral","uv_filter":true,"page":"/mineral-sunscreens/titanium-dioxide","spf_record":"titanium-dioxide","aliases":["titanium dioxide","tio2","ci 77891","77891","titanium oxide","titanium dioxide nano","nano titanium dioxide","titanic anhydride"],"coverage":{"full":["UVB"],"partial":["UVA II","UVA I"],"visible":false,"centre":"UVB","centre_note":"+ partial UVA","source":["https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_136.pdf","https://pmc.ncbi.nlm.nih.gov/articles/PMC3781714/"],"read":"2026-09-22","note":"A semiconductor, so it has an absorption edge rather than a peak. Smijs and Pavel: titanium dioxide is “primarily a UVB absorbing compound”, and the SCCS extinction tables fall roughly fourfold from 308 nm to 400 nm."},"lambda_max":null,"us":{"status":"proposed GRASE","max_percent":25,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at up to 25%; the FDA proposed a positive GRASE finding in 2019 and has not finalized it."},"eu":{"status":"Annex VI entries 27 and 27a","max_percent":25,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"Non-nano and nano combined must not exceed 25%; the nano form may not be used where the lungs could be exposed by inhalation."},"ca":{"status":"monograph","max_percent":25,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true,"note":"Nano and non-nano must sum to 25% or less; nano forms are barred from aerosol, spray and loose-powder forms."},"au":{"status":"permitted active","max_percent":25,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true,"note":"Also permitted as an excipient, for color."},"jp":{"status":"not a listed UV absorber; no limit","max_percent":null,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"Japan's positive list covers substances that specifically absorb UV; titanium dioxide scatters it, and appears nowhere in the Standards for Cosmetics, so no concentration cap applies under that instrument."}},{"inci":"Zinc Oxide","name":"Zinc Oxide","cas":"1314-13-2","type":"mineral","uv_filter":true,"page":"/mineral-sunscreens/zinc-oxide","spf_record":"zinc-oxide","aliases":["zinc oxide","zno","ci 77947","77947","zinc white","zinc oxide nano","nano zinc oxide"],"coverage":{"full":["UVB","UVA II","UVA I"],"partial":[],"visible":false,"centre":"Broad","centre_note":"spectrum","source":["https://pmc.ncbi.nlm.nih.gov/articles/PMC3781714/"],"read":"2026-09-22","note":"The site's zinc oxide page claims 290-400 nm and the bands follow it. Smijs and Pavel put the wurtzite band gap at 3.22 eV, an absorption edge near 385 nm, so the top of UVA I is weaker than the rest of the range."},"lambda_max":null,"us":{"status":"proposed GRASE","max_percent":25,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Proposed%20Administrative%20Order%20OTC000008_Amending%20M020_Sunscreen_Signed24Sept2021.pdf"],"read":"2026-09-22","verified":true,"note":"Listed in monograph M020 at up to 25%; the FDA proposed a positive GRASE finding in 2019 and has not finalized it."},"eu":{"status":"Annex VI entries 30 and 30a","max_percent":25,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"Non-nano and nano combined must not exceed 25%; not for use where the lungs could be exposed by inhalation."},"ca":{"status":"monograph","max_percent":25,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true,"note":"Nano and non-nano must sum to 25% or less; nano forms are barred from aerosol, spray and loose-powder forms."},"au":{"status":"permitted active; no maximum set","max_percent":null,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true,"note":"Schedule 1 sets no concentration limit for zinc oxide, and the TGA's guideline records its maximum as not applicable."},"jp":{"status":"not a listed UV absorber; no limit","max_percent":null,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"Japan's positive list covers substances that specifically absorb UV; zinc oxide scatters it, and appears nowhere in the Standards for Cosmetics, so no concentration cap applies under that instrument."}},{"inci":"Iron Oxides","name":"Iron Oxide","cas":"1309-37-1","type":"pigment","uv_filter":false,"page":"/mineral-sunscreens/iron-oxide","spf_record":"iron-oxide","notes":"Not a UV filter and contributes no SPF: iron oxides absorb visible light, which is what gives a tinted sunscreen its protection against visible-light pigmentation. They are regulated as colorants rather than as sunscreen actives, which is a different regime from the five below, so no UV-filter limit is recorded here.","aliases":["iron oxides","iron oxide","ci 77491","ci 77492","ci 77499","77491","77492","77499","iron oxide red","iron oxide yellow","iron oxide black","fe2o3"],"coverage":{"full":[],"partial":[],"visible":true,"centre":"Visible","centre_note":"light only","source":["https://pmc.ncbi.nlm.nih.gov/articles/PMC7894303/"],"read":"2026-09-22","note":"Yellow iron oxide attenuates below about 500 nm, red below about 570 nm, and black across the whole visible range."},"lambda_max":null,"us":{"status":null,"max_percent":null,"source":null,"read":null,"verified":false},"eu":{"status":null,"max_percent":null,"source":null,"read":null,"verified":false},"ca":{"status":null,"max_percent":null,"source":null,"read":null,"verified":false},"au":{"status":null,"max_percent":null,"source":null,"read":null,"verified":false},"jp":{"status":null,"max_percent":null,"source":null,"read":null,"verified":false}},{"inci":"Aminobenzoic Acid","name":"PABA","cas":"150-13-0","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["paba","aminobenzoic acid","p-aminobenzoic acid","4-aminobenzoic acid","para-aminobenzoic acid","vitamin b10"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"only","source":["https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_058.pdf"],"read":"2026-09-22","note":"SCCP/1008/06: the peak for PABA crystals on skin is broad and flat across the whole UVB region."},"lambda_max":{"nm":289,"source":["https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_058.pdf"],"read":"2026-09-22","verified":true,"note":"In alcohol; 278 nm in water, 300-305 nm as crystals on skin."},"us":{"status":"not GRASE from 11 Sep 2027","max_percent":15,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/FinalAdministrativeOrderOTC000008-PABATrolamine.pdf"],"read":"2026-09-22","verified":true,"note":"Final order OTC000008-1, issued 11 September 2026, determined PABA not GRASE. It is still listed at 15% until the order takes effect."},"eu":{"status":"prohibited (Annex II entry 167)","max_percent":null,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518","https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32013R0344"],"read":"2026-09-22","verified":true,"note":"Annex VI entry 1 was emptied by Regulation (EU) No 344/2013 and the substance moved to the prohibited list."},"ca":{"status":"not in the monograph","max_percent":null,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"not in the Determination","max_percent":null,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true,"note":"Absent from Schedule 1 of the Permissible Ingredients Determination."},"jp":{"status":"Appendix 4 listed","max_percent":4.0,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"4.0% as the total of PABA and its esters, in all cosmetic types."}},{"inci":"Trolamine Salicylate","name":"Trolamine Salicylate","cas":"2174-16-5","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["trolamine salicylate","triethanolamine salicylate"],"coverage":null,"lambda_max":null,"us":{"status":"not GRASE from 11 Sep 2027","max_percent":12,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/FinalAdministrativeOrderOTC000008-PABATrolamine.pdf"],"read":"2026-09-22","verified":true,"note":"Final order OTC000008-1, issued 11 September 2026, determined trolamine salicylate not GRASE. It is still listed at 12% until the order takes effect."},"eu":{"status":"not in Annex VI","max_percent":null,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"monograph","max_percent":12,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":12,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":null,"max_percent":null,"source":null,"read":null,"verified":false}},{"inci":"Methylene Bis-Benzotriazolyl Tetramethylbutylphenol","name":"Bisoctrizole","cas":"103597-45-1","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["bisoctrizole","tinosorb m","mbbt","methylene bis-benzotriazolyl tetramethylbutylphenol","methylene bis benzotriazolyl tetramethylbutylphenol"],"coverage":{"full":["UVB","UVA II"],"partial":["UVA I"],"visible":false,"centre":"Broad","centre_note":"UVA I partial","source":["https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_129.pdf"],"read":"2026-09-22","note":"SCCS/1328/10 describes bands at about 305 nm and 350 nm, shifting to 360 nm with a shoulder at 380 nm in a micronized dispersion."},"lambda_max":{"nm":350,"source":["https://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_129.pdf"],"read":"2026-09-22","verified":true,"note":"Second band at about 305 nm."},"us":{"status":"NDA required","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.federalregister.gov/d/2015-00002"],"read":"2026-09-22","verified":true,"note":"Not in the monograph. Its Time and Extent Application was reviewed in 2015 and tentatively classified as not GRASE for lack of data; that proposal was never finalized, so it can only be sold under a new drug application."},"eu":{"status":"Annex VI entries 23 and 23a","max_percent":10,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"Nano and non-nano combined must not exceed 10%."},"ca":{"status":"monograph","max_percent":5,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":10.0,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"10.0% rinse-off and leave-on; not permitted where the product may contact mucosa."}},{"inci":"Tris-Biphenyl Triazine","name":"Tris-Biphenyl Triazine","cas":"31274-51-8","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["tris-biphenyl triazine","tinosorb a2b","tbpt","tris biphenyl triazine"],"coverage":{"full":["UVB","UVA II"],"partial":[],"visible":false,"centre":"UVB","centre_note":"+ UVA II","source":["https://pmc.ncbi.nlm.nih.gov/articles/PMC13063171/"],"read":"2026-09-22","note":"The source states coverage of the UVB and UVA II ranges; it makes no UVA I claim."},"lambda_max":{"nm":310,"source":["https://pmc.ncbi.nlm.nih.gov/articles/PMC13063171/"],"read":"2026-09-22","verified":true,"note":"In acetonitrile:isopropanol 1:1."},"us":{"status":"not in the monograph","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the monograph's list of sunscreen active ingredients."},"eu":{"status":"Annex VI entry 29","max_percent":10,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"Not permitted in sprays; the nano form must have a median primary particle size above 80 nm and be uncoated."},"ca":{"status":"not in the monograph","max_percent":null,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true,"note":"Not permitted in a spray dosage form."},"jp":{"status":"Appendix 4 listed","max_percent":10.0,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"One cap for all cosmetic types."}},{"inci":"Terephthalylidene Dicamphor Sulfonic Acid","name":"Ecamsule","cas":"92761-26-7","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["ecamsule","mexoryl sx","terephthalylidene dicamphor sulfonic acid","tdsa","terephthalylidene dicamphor sulphonic acid"],"coverage":{"full":["UVA I"],"partial":[],"visible":false,"centre":"UVA I","centre_note":"only","source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","note":"The review calls it a UVA I filter."},"lambda_max":{"nm":345,"source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","verified":true},"us":{"status":"NDA only","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.federalregister.gov/d/2015-03883"],"read":"2026-09-22","verified":true,"note":"The FDA's 2015 proposed order made a tentative determination that ecamsule up to 10% is not GRASE; it was never finalized. L'Oréal markets it in the US under approved new drug applications instead."},"eu":{"status":"Annex VI entry 7","max_percent":10,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"As the acid; the salts are covered too."},"ca":{"status":"monograph","max_percent":10,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":10,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"10% rinse-off and leave-on; not permitted where the product may contact mucosa."}},{"inci":"Drometrizole Trisiloxane","name":"Drometrizole Trisiloxane","cas":"155633-54-8","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["drometrizole trisiloxane","mexoryl xl","silatrizole"],"coverage":{"full":["UVB","UVA II"],"partial":["UVA I"],"visible":false,"centre":"Broad","centre_note":"UVA I partial","source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","note":"Two peaks, 303 nm and 341 nm; bands placed against the band edges."},"lambda_max":{"nm":341,"source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","verified":true,"note":"Second peak at 303 nm."},"us":{"status":"NDA required","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.federalregister.gov/d/2015-00002"],"read":"2026-09-22","verified":true,"note":"Not in the monograph. Its Time and Extent Application was reviewed in 2015 and tentatively classified as not GRASE for lack of data; that proposal was never finalized, so it can only be sold under a new drug application."},"eu":{"status":"Annex VI entry 16","max_percent":15,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"monograph","max_percent":15,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":15.0,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"15.0% rinse-off and leave-on — the highest cap in the appendix; not permitted where the product may contact mucosa."}},{"inci":"Diethylamino Hydroxybenzoyl Hexyl Benzoate","name":"Diethylamino Hydroxybenzoyl Hexyl Benzoate","cas":"302776-68-7","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["diethylamino hydroxybenzoyl hexyl benzoate","uvinul a plus","dhhb","hexyl 2-(4-diethylamino-2-hydroxybenzoyl)benzoate"],"coverage":{"full":["UVA I"],"partial":[],"visible":false,"centre":"UVA I","centre_note":"356 nm peak","source":["https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_130.pdf"],"read":"2026-09-22","note":"Placed from the 356 nm maximum in methanol, which sits inside UVA I. Note that SCCS/1678/25 prints 297 nm on the same page — that figure belongs to the di-n-hexyl phthalate impurity, not to the filter."},"lambda_max":{"nm":356,"source":["https://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_130.pdf"],"read":"2026-09-22","verified":true,"note":"In methanol; 358 nm in 0.1 M methanolic HCl."},"us":{"status":"not in the monograph","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the monograph's list of sunscreen active ingredients."},"eu":{"status":"Annex VI entry 28","max_percent":10,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"Regulation (EU) 2026/909 adds a 10 ppm cap on di-n-hexyl phthalate as an unavoidable trace impurity, in force from 1 January 2027."},"ca":{"status":"not in the monograph","max_percent":null,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":10.0,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"10.0% rinse-off and leave-on; not permitted where the product may contact mucosa."}},{"inci":"Ethylhexyl Triazone","name":"Ethylhexyl Triazone","cas":"88122-99-0","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["ethylhexyl triazone","octyl triazone","uvinul t 150","eht","uvinul t150","2,4,6-trianilino-p-carbo-2'-ethylhexyl-1'-oxy-1,3,5-triazine"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"only","source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","note":"The review calls it a UVB filter."},"lambda_max":{"nm":314,"source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","verified":true},"us":{"status":"NDA required","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.federalregister.gov/d/2015-00002"],"read":"2026-09-22","verified":true,"note":"Not in the monograph. Its Time and Extent Application was reviewed in 2015 and tentatively classified as not GRASE for lack of data; that proposal was never finalized, so it can only be sold under a new drug application."},"eu":{"status":"Annex VI entry 15","max_percent":5,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"not in the monograph","max_percent":null,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":5,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":5.0,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"5.0% rinse-off and leave-on; not permitted where the product may contact mucosa."}},{"inci":"Diethylhexyl Butamido Triazone","name":"Iscotrizinol","cas":"154702-15-5","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["iscotrizinol","diethylhexyl butamido triazone","uvasorb heb","dbt"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"only","source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","note":"The review calls it a UVB filter and gives no absorption maximum; none was found elsewhere."},"lambda_max":null,"us":{"status":"NDA required","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.federalregister.gov/d/2015-00002"],"read":"2026-09-22","verified":true,"note":"Not in the monograph. Its Time and Extent Application was reviewed in 2015 and tentatively classified as not GRASE for lack of data; that proposal was never finalized, so it can only be sold under a new drug application."},"eu":{"status":"Annex VI entry 17","max_percent":10,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"not in the monograph","max_percent":null,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"not in the Determination","max_percent":null,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true,"note":"Absent from Schedule 1 of the Permissible Ingredients Determination."},"jp":{"status":"not permitted","max_percent":null,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the Appendix 4 positive list, and only listed UV absorbers may be used in Japanese cosmetics."}},{"inci":"Polysilicone-15","name":"Polysilicone-15","cas":"207574-74-1","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["polysilicone-15","parsol slx","dimethicodiethylbenzalmalonate","benzylidene malonate polysiloxane","polysilicone 15"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"only","source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","note":"The review calls it a UVB filter."},"lambda_max":{"nm":312,"source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","verified":true},"us":{"status":"not in the monograph","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the monograph's list of sunscreen active ingredients."},"eu":{"status":"Annex VI entry 26","max_percent":10,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"not in the monograph","max_percent":null,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"Appendix 4 listed","max_percent":10.0,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"10.0% across rinse-off, leave-on and products that may contact mucosa."}},{"inci":"Disodium Phenyl Dibenzimidazole Tetrasulfonate","name":"Disodium Phenyl Dibenzimidazole Tetrasulfonate","cas":"180898-37-7","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["disodium phenyl dibenzimidazole tetrasulfonate","neo heliopan ap","bisdisulizole disodium","dpdt"],"coverage":{"full":["UVA II"],"partial":[],"visible":false,"centre":"UVA II","centre_note":"only","source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","note":"The review calls it a UVA II filter."},"lambda_max":{"nm":335,"source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","verified":true},"us":{"status":"not in the monograph","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the monograph's list of sunscreen active ingredients."},"eu":{"status":"Annex VI entry 24","max_percent":10,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"As the acid."},"ca":{"status":"not in the monograph","max_percent":null,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"not permitted","max_percent":null,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the Appendix 4 positive list, and only listed UV absorbers may be used in Japanese cosmetics."}},{"inci":"4-Methylbenzylidene Camphor","name":"Enzacamene","cas":"36861-47-9","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["enzacamene","4-methylbenzylidene camphor","4-mbc","3-(4-methylbenzylidene)camphor","eusolex 6300","parsol 5000"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"only","source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","note":"The review calls it a UVB filter."},"lambda_max":{"nm":300,"source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","verified":true},"us":{"status":"NDA required","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.federalregister.gov/d/2015-03884"],"read":"2026-09-22","verified":true,"note":"The FDA's 2015 proposed order made a tentative determination that enzacamene is not GRASE for lack of data; it was never finalized."},"eu":{"status":"deleted from Annex VI in 2024","max_percent":null,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518","https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R0996"],"read":"2026-09-22","verified":true,"note":"Was permitted at 4%; not to be placed on the EU market from 1 May 2025 and not to be made available from 1 May 2026."},"ca":{"status":"monograph","max_percent":4,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":4,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true,"note":"Under TGA review as of the December 2025 topic-page update."},"jp":{"status":"not permitted","max_percent":null,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the Appendix 4 positive list, and only listed UV absorbers may be used in Japanese cosmetics."}},{"inci":"Isoamyl p-Methoxycinnamate","name":"Amiloxate","cas":"71617-10-2","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["amiloxate","isoamyl p-methoxycinnamate","isopentyl trimethoxycinnamate","neo heliopan e 1000","isoamyl methoxycinnamate"],"coverage":{"full":["UVB"],"partial":[],"visible":false,"centre":"UVB","centre_note":"only","source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","note":"Placed from the 308 nm maximum the review reports."},"lambda_max":{"nm":308,"source":["https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","verified":true},"us":{"status":"NDA required","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf","https://www.federalregister.gov/d/2015-00002"],"read":"2026-09-22","verified":true,"note":"Not in the monograph. Its Time and Extent Application was reviewed in 2015 and tentatively classified as not GRASE for lack of data; that proposal was never finalized, so it can only be sold under a new drug application."},"eu":{"status":"Annex VI entry 14","max_percent":10,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true},"ca":{"status":"not in the monograph","max_percent":null,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":10,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true},"jp":{"status":"not permitted","max_percent":null,"source":["https://www.mhlw.go.jp/content/001257665.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the Appendix 4 positive list, and only listed UV absorbers may be used in Japanese cosmetics."}},{"inci":"Phenylene Bis-Diphenyltriazine","name":"Phenylene Bis-Diphenyltriazine","cas":"55514-22-2","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["phenylene bis-diphenyltriazine","triasorb","pbdt","phenylene bis diphenyltriazine"],"coverage":{"full":["UVB","UVA II","UVA I"],"partial":[],"visible":true,"centre":"Broad","centre_note":"+ visible","source":["https://health.ec.europa.eu/document/download/a056c28e-9170-40c4-a9bd-e169e47a3a20_en?filename=sccs_o_215.pdf","https://pubmed.ncbi.nlm.nih.gov/34643936/"],"read":"2026-09-22","note":"Described as a broad-spectrum UVB and UVA filter including long UVA that also absorbs visible light, especially in the high-energy region."},"lambda_max":{"nm":329,"source":["https://health.ec.europa.eu/document/download/a056c28e-9170-40c4-a9bd-e169e47a3a20_en?filename=sccs_o_215.pdf"],"read":"2026-09-22","verified":true,"note":"10 µg/ml in dichloromethane."},"us":{"status":"not in the monograph","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the monograph's list of sunscreen active ingredients."},"eu":{"status":"Annex VI entry 31","max_percent":5,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"Not for use where the lungs could be exposed by inhalation."},"ca":{"status":"not in the monograph","max_percent":null,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"not in the Determination","max_percent":null,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true,"note":"Absent from Schedule 1 of the Permissible Ingredients Determination."},"jp":{"status":null,"max_percent":null,"source":null,"read":null,"verified":false}},{"inci":"Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate","name":"Mexoryl 400","cas":"1419401-88-9","type":"organic","uv_filter":true,"page":null,"spf_record":null,"aliases":["methoxypropylamino cyclohexenylidene ethoxyethylcyanoacetate","mexoryl 400","mce"],"coverage":{"full":["UVA I"],"partial":[],"visible":false,"centre":"UVA I","centre_note":"only","source":["https://health.ec.europa.eu/document/download/d430932d-77a6-4fa7-957d-93b2e35e1a7b_en","https://doi.org/10.3390/cosmetics10040101"],"read":"2026-09-22","note":"A UVA I filter; the 385 nm maximum sits at the far end of the band."},"lambda_max":{"nm":385,"source":["https://health.ec.europa.eu/document/download/d430932d-77a6-4fa7-957d-93b2e35e1a7b_en"],"read":"2026-09-22","verified":true},"us":{"status":"not in the monograph","max_percent":null,"source":["https://www.accessdata.fda.gov/drugsatfda_docs/omuf/monographs/OTCMonograph_M020-SunscreenDrugProductsforOTCHumanUse.pdf"],"read":"2026-09-22","verified":true,"note":"Absent from the monograph's list of sunscreen active ingredients."},"eu":{"status":"Annex VI entry 32","max_percent":3,"source":["https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:02009R1223-20260518"],"read":"2026-09-22","verified":true,"note":"Not for use where the lungs could be exposed by inhalation; no nitrosating agents, nitrosamine content at most 50 µg/kg, nitrite-free containers."},"ca":{"status":"not in the monograph","max_percent":null,"source":["https://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq?atid=sunscreen-ecransolaire2&lang=eng"],"read":"2026-09-22","verified":true},"au":{"status":"permitted active","max_percent":3,"source":["https://www.legislation.gov.au/F2026L00707/asmade/text"],"read":"2026-09-22","verified":true,"note":"Restricted to one sponsor until 20 June 2027; no nitrosating substances and nitrosamine below 50 ppb."},"jp":{"status":null,"max_percent":null,"source":null,"read":null,"verified":false}}]
}
