FDA Approves Bemotrizinol as First New Sunscreen Ingredient in 20 Years
The FDA approved bemotrizinol as a new active ingredient for over-the-counter sunscreen products on June 9, 2026. It is the first new sunscreen ingredient approved in the United States in approximately 20 years. Manufacturers can begin using it in products starting August 9, 2026.
The Food and Drug Administration approved bemotrizinol as a new active ingredient for over-the-counter sunscreen products on June 9, 2026. It is the first new sunscreen ingredient approved in the United States in roughly 20 years.
The FDA finalized the order after reviewing a request from DSM Nutritional Products LLC, which proposed using bemotrizinol at concentrations up to 6 percent. Following a public comment period that closed in January 2026, the agency determined the ingredient is generally recognized as safe and effective for adults and children aged 6 months and older.
Bemotrizinol is a chemical filter that blocks both ultraviolet A and ultraviolet B rays. It is highly photostable, meaning it does not break down quickly when exposed to sunlight. It also shows low levels of absorption through the skin.
Dermatologists say the ingredient allows for better product formulations. It can reduce the need for high concentrations of multiple filters and can be combined with mineral ingredients like zinc oxide to provide broad protection without leaving a white cast on the skin.
Bemotrizinol has been used safely in Europe and Asia for years. The United States classifies sunscreens as over-the-counter drugs rather than cosmetics, which makes the approval process more rigorous and has historically slowed the introduction of new ingredients.
Manufacturers can begin incorporating bemotrizinol into products starting August 9, 2026. The ingredient is expected to debut under the brand name Parsol Shield, made by DSM Nutritional Products. After an 18-month exclusivity period, other manufacturers can use it in their own formulations.
