For the first time in two decades, Americans will have access to a new sunscreen ingredient. The Food and Drug Administration has added bemotrizinol to the list of permitted active ingredients, the first addition to the over-the-counter sunscreen monograph since the late 1990s.

Bemotrizinol protects against both UVA and UVB rays and shows low levels of absorption through the skin into the body. The FDA considers it generally recognized as safe and effective for adults and children six months and older.

Health and Human Services Secretary Robert F. Kennedy Jr. pointed to the Trump administration’s MAHA Strategy Report as the impetus. “Bemotrizinol has been used safely in Europe for decades, and FDA’s action will increase competition and consumer confidence in sunscreen products,” he said.

The ingredient was approved through a streamlined process established by the CARES Act, the first new active ingredient added to an OTC monograph under that framework. The FDA finalized the action within seven months of issuing its proposed order. DSM Nutritional Products LLC submitted the initial request for bemotrizinol at concentrations up to 6 percent.

The move aligns with the Make America Healthy Again Strategy Report’s directive that “FDA will promote innovation in the sunscreen market, and improve regulatory processes for over-the-counter sunscreen, which has fallen behind other countries.”

Source: FDA Press Release