On June 10, 2026, FDA issued Final Administrative Order OTC000039, adding bemotrizinol (BEMT) to the list of permitted active ingredients in the OTC Sunscreen Monograph (M020). That makes it the first new sunscreen active ingredient added to the U.S. OTC monograph since the late 1990s. The order was initiated by a Tier 1 OTC Monograph Order Request (OMOR) submitted by DSM Nutritional Products LLC on September 23, 2024, and follows a proposed order issued December 12, 2025, which we commented on at the time. This is also the first active ingredient added to any OTC monograph through the CARES Act's streamlined administrative order process.
What Did FDA Do?
FDA determined that BEMT is generally recognized as safe and effective (GRASE) at concentrations up to 6% in broad-spectrum sunscreen products for adults and children six months of age and older. The order establishes specific conditions for BEMT's use, including:
- Maximum concentration of 6%, with a minimum finished-product 2 SPF
- Combinations with other permitted sunscreen active ingredients are allowed, except PABA or trolamine salicylate
- Permitted dosage forms: oil, lotion, cream, gel, butter, paste, ointment, stick, and spray, but only pump sprays or bag-on-valve systems (no propellant-combined aerosols)
- Powder is not permitted
The final order also differs from the proposed order in two key ways:
- Aerosol spray definitively rejected. DSM submitted stability data during the comment period to support propellant-based aerosol sprays. FDA found the data insufficient and formally closed the door on both aerosol sprays and powder dosage forms at this time
- Exclusivity confirmed. The proposed order deferred this question; the final order grants DSM 18 months of exclusivity from August 9, 2026
FDA received approximately 50 public comments during the comment period. DSM submitted additional data attempting to support an aerosol spray form; FDA found that data insufficient and finalized the order without change.
Why Is This a Big Deal?
For decades, the U.S. sunscreen market has lagged behind Europe and Asia in available UV filter technologies. The 2014 Sunscreen Innovation Act failed to deliver results because of data-sufficiency concerns and procedural burdens. The CARES Act of 2020 replaced that framework, and the BEMT final order is the first successful use of that process. There are a few other reasons this action stands out:
- BEMT provides broad-spectrum UVA and UVB protection with a single filter
- Unlike mineral filters such as zinc oxide and titanium dioxide, BEMT is an oil-soluble organic UV filter with high molecular weight and demonstrated low systemic absorption
- BEMT has a substantial real-world safety record from decades of use in Europe and other markets, which informed FDA's GRASE determination
- The action aligns with the MAHA Strategy Report's directive that FDA promote sunscreen innovation and modernize OTC regulatory processes
- The roughly 15-month OMOR-to-final-order timeline demonstrates improvement in FDA processing speed for monograph amendments
What Happens Next?
Manufacturers may formulate and market OTC sunscreens containing BEMT at up to 6% without a separate New Drug Application, provided the product otherwise complies with all Monograph M020 requirements. Key practical considerations:
- Formulators should review the final order closely to confirm permissible concentrations, permitted combination ingredients, and dosage form restrictions
- DSM holds 18 months of exclusivity from August 9, 2026. Other manufacturers should evaluate their timelines and licensing options accordingly
When Will Products with BEMT Be on Shelves?
The final order's effective date is August 9, 2026, at which point DSM may begin lawfully marketing BEMT-containing sunscreens. Broader market entry by other manufacturers will depend on the 18-month exclusivity window and their formulation readiness. Practical factors that will affect timing include:
- Formulation and stability testing: SPF, broad-spectrum, water-resistance, and shelf-life testing must be completed
- Manufacturing scale-up: Supply chains and manufacturing processes must be established for U.S. commercial-scale production
Given DSM's exclusivity, early U.S. market products will likely come from DSM or its licensees. Broader product availability from other manufacturers is expected in 2028 and beyond.
Please call us if you have any questions about FDA's proposed order or your sunscreen products.