The U.S. is set to enhance its sunscreen products following a significant approval by the Food and Drug Administration (FDA). The agency has given the green light to bemotrizinol, a chemical already popular in sunscreens across Europe and Asia, marking its debut in American products by June 2026. This approval is anticipated to boost sunscreen usage among Americans.
Michael Scaturro, a seasoned health journalist at KFF Health News, sheds light on bemotrizinol’s potential impact. He noted, “This is a sunscreen chemical, a UV filter that has actually been used in Europe and in Asia for about 20 years. It is incredibly safe.” The chemical’s approval is expected to enhance sunscreen’s appeal due to its superior protective qualities and cosmetic elegance.
Understanding the FDA’s Approval Process
Scaturro explains the unique challenges faced in the U.S., where sunscreen chemicals are regulated as over-the-counter drugs, necessitating rigorous FDA approval akin to medications like aspirin. This process often involves animal testing, a contentious issue not required in Europe and Asia where sunscreens fall under cosmetic regulations.
The FDA’s insistence on animal testing posed hurdles for DSM, the Dutch-Swiss company behind bemotrizinol. However, after two decades of negotiations, the company complied with these requirements, leading to the chemical’s eventual approval.
The Potential Impact on Skin Cancer Prevention
With skin cancer diagnoses rising in the U.S., there is optimism that bemotrizinol could contribute to reversing this trend. The chemical enables the creation of sunscreens that are more appealing and effective against both UVA and UVB rays. “This chemical, this UV filter, will allow manufacturers to do two things: to make sunscreens that people will really want to wear, that look good on the skin, that are less greasy, and that just like feel feel a lot better,” Scaturro stated.
Challenges in Sunscreen Adoption
Despite the availability of effective sunscreens, many Americans, especially men, remain reluctant to use them. The Centers for Disease Control and Prevention (CDC) reports that only a small percentage of men regularly use sunscreen. Improved formulations like those containing bemotrizinol may encourage more consistent use.
Although existing U.S. sunscreens are effective, they predominantly block UVB rays, with limited UVA protection. Bemotrizinol’s introduction offers a new solution for comprehensive sun protection, potentially motivating more people to incorporate sunscreen into their daily routines.
Future Prospects for Sunscreen Innovation
Scaturro notes that numerous innovative sunscreen filters already used internationally remain inaccessible in the U.S. due to regulatory challenges. Despite legislative efforts urging the FDA to accept alternative testing data, the agency remains firm on its requirements.
For further advancements in sunscreen technology, collaboration among manufacturers may be necessary to share the costs associated with FDA approval. However, the current climate suggests it may be some time before additional new filters enter the U.S. market.
As Michael Scaturro articulated, the path forward may require industry collaboration: “If we want the FDA and the U.S. government to sort of consider new sunscreen chemicals, then the makers of these chemicals and the sunscreen manufacturers will have to form a kind of coalition and sort of share the costs.”
















