FDA Just Added the First New Sunscreen Active Ingredient in Nearly 30 Years
Topline summary: The FDA has approved bemotrizinol as the first new active sunscreen ingredient in nearly 30 years, creating both an opportunity and a compliance obligation for OTC drug and cosmetic importers. Being permitted to use the ingredient is not the same as being compliant. Manufacturers and importers still need to confirm their reformulated product meets every condition of the updated monograph, including SPF testing, Drug Facts labeling, and valid FDA drug establishment registration and drug listing before goods ship.
On June 9, 2026, the FDA issued a final order adding bemotrizinol to the OTC sunscreen monograph (M020)—the first new sunscreen active ingredient permitted in the United States in nearly three decades. The ingredient, submitted by DSM Nutritional Products at concentrations up to 6 percent and long marketed in Europe, is now recognized by FDA as generally recognized as safe and effective (GRASE) for adults and children six months and older.
For manufacturers and importers of sunscreens and other OTC drug and cosmetic products, this is a real opportunity—and a regulated change that touches your formulation, your labeling, your drug establishment registration, and your treatment at the U.S. border. A new permitted active ingredient is not a green light to ship. It is a trigger to confirm your pre-compliance posture before the first entry.
The Challenge: “Permitted” Is Not the Same as “Compliant”
A GRASE listing means bemotrizinol may be used in OTC sunscreens. It does not mean your reformulated product automatically conforms to monograph M020. Sunscreen is regulated by FDA as an […]
