FDA Adds Bemotrizinol to OTC Sunscreen Monograph in First New UV Filter in Over 20 Years
Key Takeaways
- The FDA has added bemotrizinol to the OTC sunscreen monograph, making it the first new sunscreen active ingredient approved for the US market in more than two decades.
- Bemotrizinol is a broad-spectrum UV filter that the FDA determined is generally recognized as safe and effective (GRASE) for adults and children aged 6 months and older at concentrations up to 6%.
- The action represents the first addition to the OTC sunscreen monograph under the CARES Act administrative order process and may pave the way for future sunscreen innovation.
The US Food and Drug Administration (FDA) has finalized an administrative order adding bemotrizinol as a permitted active ingredient in over-the-counter (OTC) sunscreen products, marking the first addition of a new sunscreen active ingredient to the OTC sunscreen monograph since the late 1990s.
Bemotrizinol, submitted by DSM Nutritional Products LLC through an OTC Monograph Order Request, is approved for use at concentrations up to 6%. According to the FDA, the ingredient provides broad-spectrum protection against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation and demonstrates low systemic absorption following topical application, according to an agency press release on the announcement. The agency determined that bemotrizinol is generally recognized as safe and effective (GRASE) for use in adults and children aged 6 months and older.
The FDA issued a proposed order to add bemotrizinol to the sunscreen monograph in December 2025 and finalized the action after reviewing public comments. The order was completed within seven months, making bemotrizinol the first sunscreen ingredient added through the streamlined administrative process established under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.
Although bemotrizinol has been marketed for years in Europe and other international markets, its inclusion in the US OTC sunscreen monograph is expected to expand formulation options for manufacturers and increase consumer access to broad-spectrum photoprotection. FDA officials said the action reflects the agency's commitment to applying current scientific evidence while improving the efficiency of the OTC regulatory framework.
Source: FDA press release. June 9, 2026.