FDA Adds Bemotrizinol to OTC Sunscreen Monograph

SG 083/26

US Food and Drug Administration (FDA) adds a sunscreen active ingredient to the existing over-the-counter (OTC) monograph, issuing a final order on June 10, 2026.

For the first time in over 20 years, the FDA has issued a Final Administrative Order on June 10, 2026, amending the OTC sunscreen monograph (M020). The primary purpose of this order is to add bemotrizinol as an approved active ingredient for OTC sunscreen drug products. This follows a review of safety and efficacy data that concluded that bemotrizinol can be considered generally recognized as safe and effective (GRASE) when used under the defined conditions of the monograph.

Key provisions of the final order include:

• Permitted use level: Bemotrizinol is allowed in sunscreen formulations at concentrations up to 6%, provided the finished drug product provides a minimum sun protection factor (SPF) value of at least two
• Formulation conditions: products must comply with existing OTC Monograph M020 requirements, including limits on ingredient combinations and overall product conditions
• Combination use: Bemotrizinol may be used alongside certain skin protectants, subject to monograph conditions
• Dosage forms: approved product forms include oils, lotions, creams, gels, butters, pastes, ointments, sticks and specific spray formats (with restrictions on propellant contact)

The order also clarifies that sunscreen products containing bemotrizinol can be marketed without submitting a new drug application, provided they fully comply with the monograph requirements.

The FDA made no substantive changes between the proposed and final order after reviewing public comments, indicating general acceptance of the safety and efficacy assessment.

This decision represents a notable modernization of the US sunscreen framework, as it introduces a new UV filter into the OTC system and expands formulation options for manufacturers. Bemotrizinol has been widely used internationally, and its inclusion may help align US sunscreen offerings more closely with global markets while maintaining FDA safety standards.

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