FDA Approves Bemotrizinol as New Sunscreen Active Ingredient

On 9 June 2026 the U.S. Food and Drug Administration issued a final order adding bemotrizinol (up to 6%) as a generally recognized as safe and effective (GRASE) active ingredient for sunscreens intended for adults and children 6 months of age and older. This is the first new sunscreen active ingredient added to the OTC monograph in roughly two decades.

The decision followed an OTC monograph order request and public comment period. Brands may now formulate and market sunscreens containing bemotrizinol in the United States, subject to the monograph conditions and general MoCRA requirements.

Kompass Europe supports clients with U.S. sunscreen compliance, MoCRA facility and product listing, and formulation reviews.

This summary is for informational purposes only. Always verify current requirements with official sources (FDA) and seek professional advice. This does not constitute legal or regulatory advice.