Benzoyl Peroxide
Also known as: BPO, Dibenzoyl peroxide
Last updated:
Benzoyl peroxide is a leading anti-acne active. In the United States, it is classified as an OTC drug for acne under 21 CFR Part 333 at 2.5–10%. In the EU, benzoyl peroxide is permitted with specific Annex III conditions, primarily as a hair-product ingredient and in artificial-nail systems. Cosmetic-claim use is limited; most acne products fall into the drug regulatory pathway.
Regulatory status by market
| Market | Status | Detail | Source |
|---|---|---|---|
| European Union | Restricted | Annex III conditions; primarily hair and nail use | Annex III |
| United Kingdom | Restricted | Mirrors EU restrictions | UK Cosmetics Regulation |
| United States | Approval required | OTC drug for acne at 2.5-10% under 21 CFR Part 333 | 21 CFR 333 |
| Canada | Restricted | Drug or NHN classification for acne use | Health Canada |
Safety profile
Benzoyl peroxide can cause significant skin irritation, dryness, peeling, and bleaching of fabrics. It is photosensitizing. In 2024, concerns emerged about benzene formation in benzoyl peroxide drug products during storage at elevated temperatures; FDA has issued guidance on stability testing and storage conditions. Pregnant individuals should consult a healthcare provider before use.
Common uses
- OTC acne treatments (US drug, 2.5-10%)
- Hair dye oxidizing component (EU Annex III)
- Artificial nail systems (EU Annex III)
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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