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Octocrylene

2-エチルヘキシル-2-シアノ-3,3-ジフェニルアクリレート

US

OTC Monograph §352.10

EU

UV Filter (Annex VI)

JP

Quasi-drug UV

KR

Functional cosmetic

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Data last updated 27 days ago. Regulatory status can change; verify with official sources before making compliance decisions.

Also Known As

OCTOCRYLENE · Octocrilene; Octocrylene (USAN) · 2-Cyano-3,3-diphenyl acrylic acid 2-ethylhexyl ester / Octocrylene

CAS Number

6197-30-4

Max Concentration

10.0%

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

UVB filter; stabilizes avobenzone

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

2-Ethylhexyl 2-cyano-3,3-diphenylacrylate OC

Cross-Market Regulatory Rules

1 rule from official sources

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

a) Propellant spray products b) Other products | as a constituent of other substances, or in mixtures, in concentrations equal to, or greater than 0.1% by weight

Maximum concentration: 9.0%

Warning: SCCS: OPINION on Octocrylene | Regulations: (EU) 2022/1176

Citation ▼

EU CosIng Annex VI / Ref 10

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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

Octocrylene

Octocrylene

SCCS/1627/21

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Source Document

21 CFR 352.10

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