The FDA has approved bemotrizinol as a new sunscreen active ingredient — the first change to the agency’s sunscreen list in over 25 years. DSM Nutritional Products will introduce the ingredient in the U.S. as Parsol Shield, expected in late 2026, with an 18-month exclusivity window. The FDA considers bemotrizinol generally safe and effective for adults and children 6 months and older and allows its use in OTC sunscreens at concentrations up to 6%.
FDA Clears Bemotrizinol As New Sunscreen Active — Debuting As Parsol Shield In 2026
The FDA has signed off on allowing bemotrizinol to be added to sunscreen products.(iStock)
The Food and Drug Administration has added bemotrizinol to its list of approved sunscreen active ingredients — the first such update in more than 25 years. The agency concluded the ingredient provides effective protection against harmful ultraviolet (UV) radiation while causing minimal skin irritation and limited systemic absorption, according to the Associated Press.
Bemotrizinol is "generally recognized" as safe and effective for adults and children 6 months and older, according to the FDA.
Bemotrizinol has been widely used in sun-care products across Europe and other regions for decades. In the U.S., it will be introduced by Dutch manufacturer DSM Nutritional Products under the brand name Parsol Shield, which the company expects to launch late in 2026. DSM will hold exclusive U.S. marketing rights for the ingredient for an 18-month period, after which other manufacturers may incorporate bemotrizinol into their formulations.
The FDA encourages the public to use sunscreen with other protective measures.
Regulatory Details
DSM submitted a formal petition asking the FDA to authorize bemotrizinol for use in over-the-counter sunscreens at concentrations up to 6%. In a December statement issued when the petition was proposed, the FDA described bemotrizinol as "generally recognized" as safe and effective for adults and for children 6 months and older.
"We’re continuing to modernize the regulation of sunscreen and other over-the-counter drug products," said FDA Commissioner Marty Makary, MD, MPH. "Americans deserve timely access to the best safe, effective and consumer-friendly over-the-counter products available."
Acting director Karen Murry, MD, of the FDA’s Office of Nonprescription Drugs added that bemotrizinol "would be a welcome addition to the current array of effective sunscreen active ingredients already available to American consumers."
What Consumers Should Know
The FDA emphasized that approval of a new active ingredient does not replace existing sun-safety guidance. The agency continues to recommend a layered approach to sun protection: use a broad-spectrum sunscreen with at least SPF 15, wear protective clothing and hats, seek shade when the sun is strongest, and limit time in direct sunlight. The agency also monitors sunscreen products to ensure they meet safety and effectiveness standards.
Key facts: bemotrizinol provides broad-spectrum UV protection, may be used in OTC sunscreens at up to 6% concentration, is considered generally safe for ages 6 months and older, and will be sold initially as Parsol Shield with an 18-month exclusivity period for DSM.
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