FDA approves first new sunscreen ingredient in decades, bemotrizinol

The FDA has approved bemotrizinol, a sunscreen filter already used in Europe, Japan and South Korea, giving American consumers access to the first new active ingredient added to the U.S. over-the-counter sunscreen monograph since the late 1990s. The agency said the ingredient protects against both UVA and UVB rays, has low levels of absorption through the skin into the body, and is generally recognized as safe and effective for adults and children 6 months and older. Manufacturers can begin including it on Aug. 9, 2026.

The approval matters because most U.S. sunscreens still rely on a narrow set of active ingredients, leaving dermatologists and manufacturers arguing for broader UVA coverage and better-performing formulas. Bemotrizinol stands apart because it has been marketed for years in Europe and many other countries, where more filters are available and product design has moved faster than in the United States. Whether shoppers see better options quickly will depend on how fast brands reformulate, but the FDA’s action gives them a new tool that has been missing from the American market for decades.

The agency said it finalized the decision within seven months of issuing the proposed order, a notably faster timeline than the years of inaction that defined U.S. sunscreen review for much of the past quarter-century. The FDA also said the approval fit its broader push to modernize over-the-counter drug review and advance sunscreen innovation. Under current rules, sunscreen products can reach the market without an approved drug application if they meet monograph requirements, and bemotrizinol is the first new active ingredient added through the streamlined process established by the CARES Act.

That slow pace has long frustrated the dermatology community. An American Academy of Dermatology Association statement called the approval an important public health step and said it could help save lives from skin cancer, which the group described as one of the most preventable cancers. The association said Europe approved bemotrizinol in 2000 and that the United States still lags many countries with nearly twice as many approved sunscreen ingredients. The Environmental Working Group, which said it had urged the FDA since 2019 to allow bemotrizinol, also hailed the decision as a win for consumers.

The episode underscores how cumbersome the U.S. sunscreen review system became. Congress enacted the Sunscreen Innovation Act in 2014 to create an alternative review path, but the CARES Act in 2020 later overhauled the OTC process and sunsetted that law at the end of fiscal 2022. Lawmakers again pressed for change in 2025 with the SAFE Sunscreen Standards Act, while a dsm-firmenich executive told Congress that skin cancer remains the fastest-growing cancer in the United States, affecting more than 6.1 million adults and costing about $8.9 billion a year. For consumers, bemotrizinol is more than a new ingredient: it is evidence that a system built to protect public health can still take years to catch up with science and global practice.