After nearly three decades without innovation, the U.S. Food and Drug Administration has approved bemotrizinol (BEMT), the first new sunscreen ingredient since the 1990s, offering Americans a more stable and skin-friendly shield against the ultraviolet rays that drive skin cancer risk. The approval comes at a moment when dermatologists are eager for new tools in the fight against preventable skin disease.
Bemotrizinol is a chemical filter that absorbs both UVA and UVB radiation—the two primary types of ultraviolet rays that cause skin damage and increase cancer risk. What sets it apart from many sunscreens already on American shelves is that it is highly photostable, meaning it breaks down much more slowly when exposed to intense sunlight. That durability translates to longer-lasting protection. Equally important, unlike older chemical filters that have been found to enter the bloodstream at levels that concerned regulators, bemotrizinol stays mostly on the skin surface and is less likely to be absorbed into the body.
The ingredient has already logged decades of safe use in Europe and international markets, allowing the FDA to rely on existing evidence when making its decision. Because it is unlikely to cause irritation, the FDA has cleared it for use on children as young as 6 months old—a milestone that marks bemotrizinol as the first chemical UV filter recommended for infants. "Bemotrizinol would be the first chemical UV filter recommended to be used on infants due to minimal skin irritation," said Dr. Nisha Varadarajan, a dermatologist at Memorial Sloan Kettering Cancer Center in New York City.
The approval speaks to a broader shift in how the FDA handles innovation in nonprescription drugs. The proposed order was originally issued on December 12, 2025, showing how streamlined review under the CARES Act can accelerate access to new products. "Now, through the best available science and updated regulatory framework, we can work with companies to get innovative products to market in a more efficient manner than ever before," said Dr. Karen Murry, director of the Office of Nonprescription Drugs at the FDA's Center for Drug Evaluation and Research.
Manufacturers will be permitted to start including bemotrizinol in their formulas beginning August 9, with the ingredient expected to debut in the U.S. market this summer under the brand name Parsol Shield. After 18 months, other manufacturers may market products with the new ingredient, opening the category to wider competition.
The dermatology community has greeted the news with enthusiasm. Dr. Murad Alam, president of the American Academy of Dermatology, called the approval "an important public health step by expanding access to safe and effective sunscreens for consumers in the United States and helping save the lives of Americans from skin cancer." For a field that has relied on the same narrow set of active ingredients for more than two decades, bemotrizinol represents a meaningful advance—one that promises to reach even the most vulnerable skin, from infants to those living in sun-intense climates where photostability matters most.