The Food and Drug Administration approved the first new sunscreen filter in more than two decades this week, ending a 27-year dry spell that had left American consumers with fewer sun-protection options than those available in Europe and other international markets. The agency added bemotrizinol, sold under the brand name PARSOL Shield, to its list of permitted sunscreen active ingredients on Tuesday.
The ingredient has been used in European sunscreens since 2000. The FDA's decision came after years of congressional pressure and follows legislation designed to streamline the review process for new sunscreen filters. The Swiss-Dutch multinational company DSM-Firmenich submitted the approval request and will hold exclusive marketing rights to bemotrizinol for the first 18 months, serving as the sole supplier of this filter during that period.
What the Left Is Saying
Public health advocates praised the FDA's action as a victory for consumer protection. The American Academy of Dermatology Association issued a statement saying, 'The FDA announcement follows longstanding and ongoing advocacy by the American Academy of Dermatology Association to ensure that U.S. consumers have more options to protect themselves from the sun's harmful UV rays.' Former FDA Commissioner Marty Makary said in December that action on new filters had 'moved too slowly in this area,' signaling administrative support for modernization.
Consumer safety groups pointed to the Sunscreen Innovation Act of 2014 as an early congressional acknowledgment that the regulatory pathway needed reform. These advocates argue that American consumers deserve access to the same protective technologies available abroad, particularly given rising skin cancer rates. Gabriella Baki, director of the cosmetic science program at Toledo University, noted that consumer resistance to reapplying existing products has been a persistent barrier to effective sun protection.
What the Right Is Saying
Industry representatives and regulatory reform advocates highlighted the approval as evidence that recent legislative changes are working. The SAFE Sunscreen Standards Act, signed into law last year on a bipartisan basis, directed the FDA to streamline its review process for active sunscreen ingredients. Jessica O'Connell, a partner at Covington & Burling and co-chair of the firm's Food, Drug, and Device Practice Group, explained that user fees tied to the CARES Act of 2020 created incentives for the agency to dedicate resources to these submissions.
Pharmaceutical and cosmetics industry groups have long argued that regulatory delays prevented American companies from competing globally. Kenvue, owner of Neutrogena and Aveeno brands, confirmed plans to incorporate bemotrizinol into its product line. 'Once the bemotrizinol order is effective later this year, Neutrogena will integrate this filter into its sunscreen innovation pipeline, leveraging its aesthetic benefits and gentleness profile into formulations,' said Asha Patel Shah, head of skin health at Kenvue.
What the Numbers Show
The FDA's approval ends a 27-year gap since the last new sunscreen filter was added to the permitted list. Bemotrizinol is classified as Generally Recognized As Safe and Effective (GRASE), a designation that other chemical filters in U.S. sunscreens—including avobenzone, octocrylene, homosalate, and oxybenzone—do not hold. Mineral sunscreens containing zinc oxide and titanium dioxide are also GRASE-designated.
Unlike most organic filters available in the U.S., bemotrizinol provides broad-spectrum protection against both UVA and UVB radiation. Avobenzone, the only other broad-spectrum organic filter currently permitted domestically, is known for instability when exposed to UV radiation. The new ingredient has been available in Europe for 26 years without reported safety concerns of equivalent magnitude.
Companies may begin incorporating bemotrizinol into sunscreen products starting August 9, 2026.
The Bottom Line
The FDA approval marks a significant shift in U.S. sunscreen regulation after decades of inaction. For American consumers, the change means access to broader-spectrum protection that has been standard elsewhere for more than two decades. Industry observers will watch whether the expedited review pathway established under recent legislation leads to additional filter approvals.
Dermatologists and consumer advocates hope the improved product options will address compliance issues—many Americans fail to reapply existing sunscreens due to texture and cosmetic concerns. The exclusive marketing period for DSM-Firmenich means initial U.S. products containing bemotrizinol may carry a premium price. Major manufacturers including Coppertone, Banana Boat, and L'Oréal have not yet announced plans for licensing the new ingredient.