Octocrylene
Octocrylene is allowed by the FDA as an OTC sunscreen active ingredient up to 10% but in 2019 the FDA proposed that there are insufficient data to declare it Generally Recognized as Safe and Effective (GRASE), pending additional safety data. Independent studies have shown it can degrade into benzophenone, an IARC Group 2B possible human carcinogen, during product storage.
What it is
Synthetic organic UV filter (a derivative of cinnamic acid) used in sunscreens and personal-care products to absorb UVB and short UVA radiation.
Not a food ingredient; cosmetic UV filter.
Why it's flagged
- Degrades to benzophenone (IARC Group 2B possible carcinogen) during product storage
What regulators actually say
"FDA proposed that 12 of the 16 currently marketed active ingredients have insufficient safety data to make a positive GRASE determination at this time."
"Octocrylene-containing products had an average concentration of 39 mg/kg benzophenone ... after subjecting products to the FDA-accelerated stability method, the 16 octocrylene-containing products had an average concentration of 75 mg/kg."
Regulatory status
United States — FDA
Listed as OTC sunscreen active ingredient (21 CFR 352.10) up to 10%; proposed not GRASE pending more data
European Union — EFSA
Authorized as UV filter under EU Cosmetic Regulation 1223/2009 Annex VI (entry 10) up to 10%
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