FDA Approves Bemotrizinol, First New Sunscreen Filter in Over Two Decades

The FDA approved bemotrizinol (BEMT) for over-the-counter sunscreens on June 9, 2026, the first new active ingredient cleared in the U.S. since the 1990s. DSM-Firmenich will market it as PARSOL® Shield with exclusive rights for 18 months.

FDA Approves First New Sunscreen Ingredient in Two Decades

The approval ends a 27-year lull in U.S. filters. Earlier reviews used the Time and Extent Application pathway, resource-limited. 2014 Sunscreen Innovation Act, 2020 CARES Act, and SAFE Sunscreen Standards Act added incentives and a streamlined process.

The Hill

Key participants include the FDA (Karen Murry, Office of Nonprescription Drugs), DSM-Firmenich, the American Academy of Dermatology (President Murad Alam), Kenvue (Asha Patel Shah), and experts Gabriella Baki and Jessica O’Connell.

FDA Approves First New Sunscreen Ingredient in Two Decades

Bemotrizinol is a broad-spectrum organic filter blocking UVA, UVB (and, per one source, UVC). It is GRASE, highly photostable, minimally absorbed, and cleared for children as young as six months.

The Hill

The filter expands sunscreen options, addressing the UVA protection gap and offering a clear, non-whitening, cosmetically elegant alternative that may improve user adherence and potentially lower UV-related skin-cancer rates.

The Cool Down

The American Academy of Dermatology, via President Murad Alam, called the move a public-health advance. FDA’s Karen Murry cited an updated framework for faster innovation. Kenvue’s Asha Patel Shah confirmed Neutrogena will adopt the filter, and Dr. Nisha Varadarajan highlighted its suitability for infants.

FDA Approves First New Sunscreen Ingredient in Two Decades

Experts note that many organic filters can permeate the bloodstream, deterring consumers. Gabriella Baki emphasized texture and absorption concerns, while Jessica O’Connell pointed to historic FDA resource constraints that delayed review. Low-level absorption risks remain uncertain.

The Hill

Sources differ on the filter gap length—citing 25 years, “over two decades,” or the 1990s—and on spectral coverage (UVA/UVB vs. UVA/UVC). Data on pricing, market uptake, and long-term safety, especially for infants, are lacking.

The Cool Down

• “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.” — American Academy of Dermatology

The Hill

• “Where we fail is that consumers don’t want to use the product because of what they feel like or look like on the skin, don’t want to reapply those products.” — Gabriella Baki, director, BSPS Cosmetic Science and Formulation Design program, Toledo University

The Hill

• “There was more incentive for FDA to dedicate resources to reviewing these submissions, because their user fees tied to it, and so it created the process that DSM used for this particular submission,” — Jessica O’Connell, partner, Covington & Burling

The Hill

• “Bemotrizinol would be the first chemical UV filter recommended to be used on infants due to minimal skin irritation,” — Dr. Nisha Varadarajan, dermatologist, Memorial Sloan Kettering Cancer Center

FDA Approves First New Sunscreen Ingredient in Two Decades

Bemotrizinol-containing sunscreens will launch on Aug 9, 2026 under the PARSOL® Shield name. After the 18-month exclusivity, other manufacturers may use the filter. Ongoing monitoring will assess safety and market impact.

The Hill