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Oxybenzone

オキシベンゾン

US

OTC Monograph §352.10

EU

UV Filter (Annex VI)

JP

Quasi-drug UV

KR

Functional cosmetic

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Data last updated 31 days ago. Regulatory status can change; verify with official sources before making compliance decisions.

Also Known As

BENZOPHENONE-3 · Oxybenzone · 2-Hydroxy-4-methoxybenzophenone / Oxybenzone

CAS Number

131-57-7

Max Concentration

6.0%

Restriction Type

restricted

Category

uv filter

Pharmaceutical Class

OTC Drug Active

Exact Legal Citations

US CFR

21 CFR 352.10

OTC Drug Monograph

21 CFR 352 — Sunscreen Drug Products for OTC Human Use

Regulatory Notes

UVA/UVB filter; banned in Hawaii/Key West for reef safety

Cross-Jurisdiction Status

US (FDA)

OTC Monograph §352.10

EU (SCCS)

UV Filter (Annex VI)

Japan (MHLW)

Quasi-drug UV

Korea (MFDS)

Functional cosmetic

Drug-Cosmetic Boundary Note

Sunscreen active ingredients are OTC drugs in US, functional cosmetics in Korea, quasi-drugs in Japan. Same ingredient, different regulatory pathway. Claims determine classification.

Also Known As

Benzophenone-3 BP-3

Cross-Market Regulatory Rules

1 rule from official sources

EU 1 rule
allowed annex vi uv filter EU CosIng Annex Substances

a) Face products, hand products, and lip products, excluding propellant and pump spray products b) Body products, including propellant and pump spray products c) Other products | For a) and b): Contains Benzophenone-3 (*) Footnote (*): Not required if concentration is 0,5 % or less and when it is used only for product protection purposes. | a) If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 5,5 %. b) If used at 0,5 % to protect product formulation, the levels used as UV filter must not exceed 1,7 %.

Maximum concentration: 6.0%

Warning: SCCS: Evaluation of Potentially Estrogenic Effects of UV-filters; Opinion on Benzophenone-3; OPINION on Benzophenone-3 | Regulations: (EU) 2022/1176

Citation ▼

EU CosIng Annex VI / Ref 4

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Linked Scientific Evidence (1)

These evidence items are directly linked to this ingredient by our ingestion pipeline. Unlinked contextual evidence is not shown here.

opinion EU EU SCCS Opinions 2021-03-31

Benzophenone-3

Benzophenone-3

SCCS/1625/20

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Source Document

21 CFR 352.10

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