Bemotrizinol Added to FDA OTC Sunscreen Monograph in the US
BAAR, SWITZERLAND / AGILITYPR.NEWS / June 25, 2026 / SGS, the world’s leading testing, inspection and certification company, has published SafeGuardS 083.26, highlighting the US Food and Drug Administration’s (FDA) addition of bemotrizinol, an active ingredient found in sunscreen, to the over-the-counter (OTC) monograph.
A Final Administrative Order was issued on June 10, 2026, for the first time in over 20 years, with the primary purpose of adding bemotrizinol as an approved active ingredient for OTC sunscreen products. When used under the defined conditions of the monograph, bemotrizinol is considered to be generally recognized as safe and effective (GRASE). This follows a review of safety and efficacy data.
The final order includes key provisions relating to:
- Permitted use level
- Formulation conditions
- Combination use
- Dosage forms
No substantive changes were made by the FDA between the proposed and final order after reviewing public comments, indicating general acceptance of the safety and efficacy assessment.
The addition of bemotrizinol as a new UV filter represents a notable modernization of the US sunscreen framework, expanding formulation options for manufacturers. Its inclusion in the OTC monograph may help align US sunscreen offerings more closely with global markets.
SGS experts publish SafeGuardS to keep stakeholders informed about regulatory changes that could impact their business. SafeGuardS 083.26 provides further information about key provisions of the Final Order and clarification of requirements.
Stakeholders are encouraged to refer to the original SafeGuardS 083.26 for more details.
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SGS SafeGuardS keep you up to date with the latest news and developments in the consumer goods industry. Read the full FDA Adds Bemotrizinol to OTC Sunscreen Monograph SafeGuardS.
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For further information, contact Media Inquiries or:
Joseph Scognamiglio
Director of Operations, Cosmetics and Personal Care
Tel: +1 (973) 617-0482
Website: www.sgs.com/cosmetics
LinkedIn: Cosmetics & Personal Care
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