FDA approves bemotrizinol, first new sunscreen ingredient in over 25 years

The FDA has approved bemotrizinol, the first new sunscreen ingredient in the U.S. in over 20 years. Long used in Europe, the broad-spectrum, photostable filter absorbs both UVA and UVB rays with low systemic absorption. The approval, streamlined by the CARES Act, aims to close a long-standing "UVA protection gap" in the American market, offering consumers more effective options to prevent skin cancer.

Bemotrizinol FDA approval

• ▪The Environmental Working Group praised the FDA's approval, stating it will help close the UVA protection gap in U.S. sunscreens
• ▪On June 9, 2026, the U.S. Food and Drug Administration approved bemotrizinol as an active ingredient for over-the-counter sunscreens
• ▪DSM Nutritional Products LLC submitted the request to add bemotrizinol to the OTC monograph for sunscreens
• ▪The approval of bemotrizinol marks the first new sunscreen ingredient permitted in the United States in over 20 years, since the late 1990s
• ▪The FDA considers bemotrizinol to be generally recognized as safe and effective (GRASE) for adults and children aged 6 months and older
• ▪The FDA permits bemotrizinol to be used in sunscreen formulations at concentrations up to 6%

CARES Act monograph pathway

• ▪The approval was a priority of the "Make America Healthy Again" (MAHA) strategy, aimed at modernizing regulatory processes
• ▪An OTC monograph drug can be marketed without a separate approved drug application if it meets certain requirements
• ▪The FDA finalized its decision within seven months of issuing its proposed order on December 12, 2025
• ▪Bemotrizinol is the first new ingredient to be added to any OTC monograph using the CARES Act pathway
• ▪The approval was streamlined through the administrative order process established by the CARES Act, which allows for more efficient updates to OTC monographs

Bemotrizinol systemic absorption

• ▪The ingredient's larger molecules and low absorption profile may make it a preferable alternative for people with sensitive skin
• ▪The MUsT data indicated that maximal topical application of a 6% bemotrizinol formulation does not result in clinically meaningful systemic exposure or drug accumulation
• ▪A maximum usage trial (MUsT) showed that plasma concentrations of bemotrizinol rarely exceeded the FDA's 0.5 ng/mL threshold
• ▪Bemotrizinol is a chemical UV filter with low levels of absorption through the skin into the body

US UVA protection gap

• ▪Unlike many mineral sunscreens, bemotrizinol formulations can be designed to dry without leaving a visible white cast
• ▪Prior to this approval, bemotrizinol had been used safely for decades in Europe, Australia, and Asia, where more UV filters are available
• ▪The ingredient is photostable, meaning it resists breaking down under sunlight and can enhance the durability of other filters
• ▪Bemotrizinol is a highly effective, broad-spectrum UV filter that absorbs both UVA and UVB rays

Post-market surveillance considerations

• ▪Further evidence on bemotrizinol's effects in pediatric subpopulations and individuals with sensitive skin conditions may be warranted over time