The FDA approved the new sunscreen ingredient bemt, known as bemotrizinol or BEMT, clearing a long stalled barrier to a chemical filter widely used overseas.
The agency said BEMT provides broad spectrum protection against both UVA and UVB rays and met safety and effectiveness standards with low skin irritation and minimal systemic absorption.
Health and Human Services Secretary Robert F. Kennedy praised the decision as a step to increase competition and consumer confidence in sunscreen products.
Experts and advocacy groups described the decision as important because many US sunscreens have offered limited UVA coverage compared with international products.
Availability Safety And Regulatory Context
Manufacturers with approved formulations plan to market BEMT under the trade name Parsol Shield, with the ingredient available exclusively to one company for an 18 month period before others may use it.
The FDA reviewed BEMT at concentrations up to six percent and evaluated how it interacts with other filters, concluding it is generally well tolerated and has low dermal penetration in clinical studies.
Chemists note BEMT molecules are relatively large and photostable, traits that help them resist breakdown in sunlight and reduce absorption through the skin, according to industry and academic commenters.
Advocacy groups such as the Environmental Working Group said the approval helps address a persistent UVA protection gap, citing their analysis that US sunscreens deliver substantially less UVA coverage than SPF labels imply.
Formulators expect BEMT to improve sunscreen textures and reduce white cast when combined with mineral filters like zinc oxide, which may increase user acceptance and consistent application, industry experts said.
Researchers continue to study BEMT’s behavior in environments such as pool water and the nature of any degradation byproducts, and regulators limited concentrations to manage safety and efficacy concerns.
With the new filter approved, observers say the decision may ease the pathway for additional international filters to enter the US market, though the first product launches will be limited by the exclusivity arrangement.
