Oxybenzone
INCI: Benzophenone-3
Also known as: Benzophenone-3, BP-3, 2-Hydroxy-4-methoxybenzophenone
Last updated:
Oxybenzone is a chemical UV filter under increased regulatory scrutiny worldwide. The EU permits it at up to 6% as a UV filter (Annex VI #4). In the US, it is FDA-approved up to 6% under the OTC sunscreen monograph, but FDA's 2019 sunscreen rule proposal flagged oxybenzone as one of the chemical UV filters with systemic absorption above FDA's safety threshold, requiring additional data. Hawaii and Key West have banned it for environmental reasons.
Regulatory status by market
| Market | Status | Detail | Source |
|---|---|---|---|
| European Union | Restricted | Max 6% as UV filter | Annex VI #4; SCCS/1625/20 |
| United Kingdom | Restricted | Max 6% | UK Cosmetics Regulation |
| United States | Conditionally permitted | Max 6% under OTC sunscreen monograph; FDA seeking additional safety data | 21 CFR 352; FDA 2019 proposed rule |
| Hawaii | Prohibited | Banned from sale since 2021 (Act 104) | Hawaii Act 104 |
| Canada | Restricted | Approved sunscreen active with concentration limit | Health Canada |
Safety profile
Oxybenzone has higher systemic absorption than mineral filters. FDA's 2020 MUsT study found oxybenzone reaches blood concentrations exceeding 0.5 ng/mL after a single application — the threshold above which FDA requires non-clinical safety data. SCCS has reviewed oxybenzone and reduced the EU limit from 10% to 6% to address aggregate exposure concerns. Hawaii's Act 104 banned octinoxate and oxybenzone over coral reef toxicity.
Common uses
- Chemical sunscreens (typically blended with other UV filters)
- Daily-wear SPF moisturizers
- Color cosmetics with SPF claims
Primary sources
Regulatory status is current to the "Last updated" date above. Always verify against the regulator's authoritative publication for the specific market and product category before relying on this summary for compliance decisions.
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