The US Food and Drug Administration (FDA) issued a Final Administrative Order on June 10, 2026, amending the OTC sunscreen monograph (M020) for the first time in over 20 years. The primary purpose of this order is to add bemotrizinol as an approved active ingredient for over-the-counter (OTC) sunscreen drug products.
Key Provisions of the Final Order
The order 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.
- Permitted use level: Bemotrizinol is allowed in sunscreen formulations at concentrations up to 6%, provided the finished drug product has 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)
- Marketing: Sunscreen products containing bemotrizinol can be marketed without submitting a new drug application, provided they fully comply with the monograph requirements
Aligning with Global Sunscreen Markets
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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Bemotrizinol FAQ
1. What UV types does Bemotrizinol cover?
In most formulations, it protects against UVA and UVB (broad-spectrum). It’s often used as a high-performance filter in sunscreen products.
2. Is Bemotrizinol suitable for sensitive skin?
It’s often described as well-tolerated, but it depends on the entire product formula (e.g., emulsifiers, alcohol, fragrance, preservatives). If you have very sensitive skin, do a patch test.
3. Can I use Bemotrizinol daily?
Yes. It’s commonly used for everyday UV protection, especially in products aiming for long-lasting, broad-spectrum coverage. Use enough product for adequate protection and reapply when needed.
