For the first time in more than a quarter century, Americans will soon have access to a new sunscreen ingredient that has long been available in other parts of the world.

The Food and Drug Administration (FDA) announced that it has approved bemotrizinol, a chemical filter already used across Europe and other regions, for inclusion in U.S. sunscreen products.

According to the agency, bemotrizinol met its standards for effective ultraviolet protection while showing minimal skin absorption and irritation.

The ingredient will debut under the name Parsol Shield, produced by Dutch manufacturer DSM Nutritional Products, with a launch expected later in 2026.

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Following an 18-month exclusivity period, other sunscreen manufacturers will be allowed to use bemotrizinol in their own formulations.

In its evaluation, the FDA determined that bemotrizinol can be safely used in over-the-counter sunscreens at concentrations up to 6%.

The health agency specified that the ingredient is "generally recognized" as safe and effective for adults and children six months and older.

FDA Commissioner Marty Makary, MD, MPH, said in a statement that the agency has "historically moved too slowly in this area, leaving Americans with fewer options than consumers abroad."

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He added, "We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products. 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 in Maryland, also praised the move, describing bemotrizinol as "a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers."

She said the FDA looks forward to working with more companies to bring new active ingredients to market "in a much more timely fashion than was possible in the past."

The agency continues to emphasize the importance of broad sun protection, encouraging consumers to use sunscreens with SPF 15 or higher along with protective clothing and limited sun exposure.

FDA officials maintain that oversight of sunscreen products remains a public health priority to ensure they meet safety and efficacy standards.

The introduction of bemotrizinol represents a major regulatory milestone, expanding options for consumers seeking advanced UV defense amid growing concerns about skin cancer and aging.