FDA approves bemotrizinol, first new U.S. sunscreen active ingredient in more than two decades

The Food and Drug Administration approved bemotrizinol, a sunscreen ultraviolet filter previously approved and sold internationally, marking the first new sunscreen active ingredient approved in the United States in more than two decades, The Hill reported. The approval breaks what the report described as a 27-year dry spell, giving manufacturers a new tool for formulating broad-coverage sun protection products that had not been available in the U.S. market for years.

Bemotrizinol is sold under the brand name PARSOL internationally, and the newly approved ingredient is expected to appear in U.S. sunscreen products after manufacturers complete any necessary steps to market formulations using the new filter. The Hill reported that the ingredient is not new to global markets, with the primary change being that U.S. regulators are now clearing it for domestic use.

The FDA’s action addresses a long period in which sunscreen filters available to American consumers had not expanded with a new ultraviolet filter. The Hill’s report framed the approval as an FDA update that “catches up” to other countries where bemotrizinol has already been part of the sunscreen ingredient landscape.

Industry representatives indicated that the approval could broaden formulation options, but the practical impact will depend on how companies file and market products that use the approved filter. The Hill reported that the approval sparked industry-wide attention, pointing to the role of FDA clearance in determining what ingredients can be sold in the United States as sunscreen actives.

Regulatory approvals for sunscreen ingredients are significant because they affect what can be used in products marketed for sun protection, including how new formulations meet FDA requirements for safety and effectiveness. The new filter also increases the range of active-ingredient choices for manufacturers, which can affect product performance characteristics such as coverage behavior and formulation design, though those specifics depend on individual products.

The agency’s approval comes as sunscreen remains a heavily used consumer product, and FDA actions on active ingredients are closely tied to oversight of labeling and marketing claims. The Hill’s reporting indicated the FDA moved forward with the bemotrizinol decision this week, ending the extended gap in newly approved U.S. filters.

The Hill did not cite a detailed FDA order document in its summary, and without an accessible FDA announcement or approval letter in this account, the exact administrative identifiers, application details, and implementation timeline are not confirmed here beyond the reported approval and its timing. Consumers and manufacturers will ultimately look to FDA documentation and product labeling to determine which specific sunscreen products incorporate bemotrizinol.