The Food and Drug Administration ended a 27-year dry spell this week by approving bemotrizinol, a new sunscreen filter that has been widely available internationally for decades. The decision, announced Tuesday, adds the ingredient—marketed as PARSOL Shield—to the agency's list of permitted active sunscreen ingredients, a move that industry observers and dermatologists have long awaited.
Bemotrizinol has been used in Europe since 2000, but U.S. regulators only now cleared it for domestic use. The approval came after years of stalled reviews and a shift in regulatory framework under the CARES Act, which tied user fees to FDA review incentives. Former FDA Commissioner Marty Makary had signaled in December that action was imminent, noting that the agency had “moved too slowly in this area.”
Swiss-Dutch multinational DSM-Firmenich submitted the approval request and will hold exclusive marketing rights for 18 months, making it the sole supplier of the filter during that period. At least one company has already confirmed plans to incorporate bemotrizinol into its products.
The American Academy of Dermatology Association welcomed the approval, stating that it follows “longstanding and ongoing advocacy” to expand U.S. consumers' sun protection options. The group emphasized the need for more effective and user-friendly sunscreen choices.
Bemotrizinol is a chemical, or organic, sunscreen filter that offers broad-spectrum protection against both UVA and UVB radiation. Unlike many existing U.S. organic filters, it is stable under UV exposure and does not leave a white cast on the skin—a common complaint with mineral sunscreens. According to Gabriella Baki, director of the cosmetic science program at the University of Toledo, the ingredient's texture and stability are significant improvements. “A lot of our UV filters can only protect against either UVB or UVA radiation,” Baki said. “Where we fail is that consumers don't want to use the product because of what they feel like or look like on the skin.”
Another key distinction: bemotrizinol is classified by the FDA as Generally Recognized as Safe and Effective (GRASE), a status that other chemical filters like avobenzone, octocrylene, homosalate, and oxybenzone lack. Mineral sunscreens in the U.S. are also considered GRASE. Baki noted that the new filter does not absorb into the bloodstream as much as other organic filters, addressing a common consumer concern.
The long delay in approving new sunscreen filters has drawn criticism from lawmakers and public health advocates. The Sunscreen Innovation Act of 2014 aimed to create a faster review pathway but failed to produce results. It took the CARES Act of 2020—passed amid the pandemic—to provide the FDA with the resources and incentives to act. Jessica O'Connell, a partner at Covington & Burling and co-chair of the firm's Food, Drug, and Device Practice Group, explained that the FDA had long claimed it lacked resources to review new filters. “There was more incentive for FDA to dedicate resources to reviewing these submissions because their user fees tied to it,” she said, noting that DSM's submission used the new process.
The bipartisan SAFE Sunscreen Standards Act, signed into law last year, further built on these provisions. Critics argue that the U.S. regulatory system has lagged behind global standards, leaving Americans with fewer and often less effective sunscreen options for nearly three decades.
