The U.S. sunscreen market is finally getting a long-awaited update.
The FDA has officially added bemotrizinol (BEMT) to the over-the-counter sunscreen monograph, making it the first new UV filter approved for use in U.S. sunscreens since 1999. The decision ends years of industry frustration over regulatory gridlock and brings the U.S. closer to international markets that have relied on the ingredient for decades.
The approval has immediate implications for leading suppliers. BASF announced that it will now market bemotrizinol in the United States under its Tinosorb S brand, adding one of the industry's most established broad-spectrum UV filters to its domestic sun care portfolio. Originally developed by Ciba Specialty Chemicals before becoming part of BASF through acquisition, Tinosorb S has long been considered a benchmark for efficacy and photostability in global sunscreen formulations.
Canada's decision earlier this year to add bemotrizinol (which dsm-firmenich markets under the Parsol Shield brand) to its Secondary Sunscreen Monograph represented a significant win for multifunctional beauty products. By allowing the photostable, broad-spectrum UV filter at concentrations of up to 6% in daily-use cosmetics, regulators enabled brands to create globally aligned formulations that combine advanced sun protection with lightweight, consumer-friendly textures. The move is expected to streamline product development, simplify supply chains and accelerate the launch of next-generation moisturizers, skin tints and hybrid complexion products.
Known chemically as bis-ethylhexyloxyphenol methoxyphenyl triazine, bemotrizinol delivers broad-spectrum UVA and UVB protection while exhibiting exceptional photostability and low skin absorption. The FDA determined the ingredient is generally recognized as safe and effective (GRASE) for adults and children six months of age and older, allowing use at concentrations of up to 6%.
Tinosorb S was specifically designed to provide reliable protection across the UV spectrum, with absorption peaks at approximately 310 nm and 340 nm. In addition to functioning as a highly effective UV filter, it also serves as a photostabilizer for more photo-unstable UV filters, including avobenzone. This capability is particularly important in the U.S. market, where formulators have historically faced limited options for achieving robust UVA protection. When combined with avobenzone or zinc oxide, bemotrizinol can reportedly help sunscreen formulations achieve critical wavelength values above 370 nm, supporting stronger broad-spectrum performance.
The ingredient's large molecular structure contributes to low percutaneous absorption and a favorable tolerability profile, making it well suited for high-performance formulations targeting sensitive skin. Its combination of efficacy, photostability and formulation flexibility has helped establish bemotrizinol as a cornerstone of modern sunscreen systems across Europe, Asia and other international markets.
The decision also marks the first successful addition of a sunscreen active through the streamlined OTC monograph process established under the CARES Act. DSM Nutritional Products submitted the original request, with the FDA moving from proposed order to final approval in just seven months—a timeline that could signal a more efficient pathway for future sunscreen innovations.
For formulators and sun care brands, the approval creates new opportunities to develop higher-performance broad-spectrum products while addressing growing consumer demand for advanced UV protection technologies already commonplace in other global markets. The arrival of both BASF's Tinosorb S and dsm-firmenich's Parsol Shield in North America further underscores the ingredient's strategic importance and signals a new era of sunscreen innovation in the region.
The announcement also aligns with the Trump Administration's Make America Healthy Again (MAHA) strategy, which specifically called for modernizing sunscreen regulation and accelerating innovation in a category many industry observers have argued has lagged behind Europe and Asia for years.
