The FDA has updated the list of approved sunscreen ingredients for the first time in over 25 years, clearing bemotrizinol for U.S. use and paving the way for a product called Parsol Shield to appear on shelves in 2026, with an 18-month exclusivity period before other makers can use the ingredient.
This move officially adds bemotrizinol to the pool of active sunscreen chemicals after the agency concluded it protects against ultraviolet rays while causing little irritation or absorption into the skin. The approval reflects a rare regulatory shift that expands consumer options for sun protection in the United States.
Bemotrizinol has been widely used abroad for years, so its arrival here narrows the gap between American offerings and overseas markets. For everyday sun care shoppers this means another tool to block UVA and UVB damage and to reduce dependence on a narrower set of ingredients.
The ingredient will initially be marketed under the name Parsol Shield by the maker DSM, which plans a 2026 launch for its product. After that launch, other manufacturers will be permitted to use bemotrizinol once the 18-month exclusivity window ends, opening the door to broader product availability.
DSM submitted the formal application that kickstarted the FDA review, asking permission for bemotrizinol to be used at concentrations up to 6 percent in over-the-counter sunscreens. Regulators assessed safety and performance, and the submission included data supporting its skin protection profile and low systemic absorption.
In its review the agency stated that bemotrizinol is “generally recognized” as safe and effective for adults and children 6 months and older. That specific wording signals confidence in the ingredient’s risk profile and clarifies age recommendations for consumer use.
FDA Commissioner Marty Makary, MD, MPH, commented in a statement that the agency has “historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad.” “We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products,” he said in the release. “Americans deserve timely access to the best safe, effective and consumer-friendly over-the-counter products available.”
Karen Murry, MD, acting director of the Office of Nonprescription Drugs, called bemotrizinol “would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers.” “We look forward to working with other companies on bringing products containing other new active ingredients to market for a wide array of conditions in multiple therapeutic areas, in a much more timely fashion than was possible in the past,” she added.
The FDA continues to regulate sunscreens to make sure they meet safety and effectiveness standards while urging people to layer protection methods. That advice includes using broad-spectrum sunscreens with an SPF of 15 or higher, wearing protective clothing, and limiting direct sun exposure to help reduce the risk of skin cancer and signs of premature aging.
