The United States has approved a new sunscreen ingredient for the first time in more than two decades. The compound, bemotrizinol (BEMT), has been widely used in Europe and Asia for years and is expected to expand the range of sun-protection options available to American consumers.
The decision marks a significant development in a market that has seen little innovation since the late 1990s. Dermatologists and public health advocates say the ingredient offers broad protection against ultraviolet radiation while addressing some of the limitations associated with existing sunscreen formulations in the United States.
The Food and Drug Administration (FDA) announced that bemotrizinol is now considered “generally recognized as safe and effective” for use in over-the-counter sunscreen products. The approval follows a request submitted by DSM Nutritional Products LLC, which sought to add the ingredient to the list of approved sunscreen filters.
Unlike many countries where sunscreens are regulated as cosmetics, the United States regulates them as non-prescription drugs, a distinction that has historically slowed the approval of new active ingredients.
A Broad-Spectrum Filter With a Long International Track Record
Bemotrizinol works by filtering both ultraviolet A (UVA) and ultraviolet B (UVB) radiation. UVA rays are associated with skin aging and wrinkles, while UVB rays are primarily responsible for sunburn.
Experts consider BEMT noteworthy because it provides UVA protection while remaining highly photostable, meaning it does not easily break down when exposed to sunlight. The Environmental Working Group (EWG), which advocated for the ingredient’s approval, said BEMT has accumulated extensive safety data through decades of use in Europe.
Dermatologists interviewed by several outlets highlighted additional advantages. Dr. Victor Quan of Northwestern University Feinberg School of Medicine told The New York Times that the ingredient tends to remain on the surface of the skin rather than being absorbed into the bloodstream. He also noted that it is less likely to cause irritation than some existing sunscreen ingredients.
Preliminary clinical trial data indicate that bemotrizinol does not appear to reach the same concentrations in human plasma as certain chemical sunscreen ingredients that became the subject of safety concerns following FDA reviews and research published in 2019.
US Sunscreen Formulas May Begin to Evolve
The approval arrives amid longstanding criticism that American sunscreen products lag behind those sold in Europe, Japan, South Korea, and Australia. According to reports, US sunscreens generally perform well against UVB radiation but have fewer options for broad UVA protection because of the limited number of approved filters.
Dermatologist Dr. Ellen Gendler told Business Insider that avobenzone has been the primary UVA-filtering ingredient available in US sunscreens, though it requires stabilization from other ingredients to remain effective. She said many international products offer broader protection and improved cosmetic performance.
Experts also noted that bemotrizinol may help manufacturers create products that are easier to apply and less likely to leave a visible white residue. Dermatologists described sunscreens containing the ingredient as more cosmetically acceptable than many mineral formulations.
Consumers will not see immediate changes on store shelves, DSM Nutritionals will hold exclusive rights for 18 months to market its proprietary bemotrizinol formulation in the United States. Other manufacturers are expected to follow afterward as the ingredient becomes available more broadly.
