The U.S. sunscreen market is finally getting a long-awaited update.
The FDA has officially added bemotrizinol to the over-the-counter sunscreen monograph, making it the first new UV filter approved for use in U.S. sunscreens since the late 1990s. The move ends years of industry frustration over regulatory gridlock and brings the U.S. closer to international markets that have been using the ingredient for decades.
Canada's decision earlier this year to add bemotrizinol (which dsm-firmenich markets under the Parsol Shield brand) to its Secondary Sunscreen Monograph represents 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 have 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 for its broad-spectrum UVA and UVB protection, photostability and low skin absorption, bemotrizinol has long been a staple in sunscreen formulations across Europe and Asia. The FDA determined the ingredient is generally recognized as safe and effective (GRASE) for adults and children aged six months and older, allowing use at concentrations up to 6%.
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 announcement 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.
