The U.S. Food and Drug Administration approved the UV-filter bemotrizinol as a new over-the-counter sunscreen active ingredient on Tuesday [1].
This approval marks a significant shift in American skincare regulation. For the first time in approximately 25 years, a new active ingredient has been added to the FDA's sunscreen monograph [2].
Bemotrizinol provides broad protection against both ultraviolet A (UVA) and ultraviolet B (UVB) rays [1]. The FDA said the ingredient has low levels of absorption through the skin into the body [1].
While new to the U.S. market, the chemical is not new globally. Bemotrizinol has been used in Europe and Asia for several decades [3]. Dr. Rachel Nazarian, a dermatologist, said the ingredient is considered safe with minimal systemic absorption [3].
An FDA spokesperson said this is the first new sunscreen active ingredient added to the agency's monograph since the late 1990s [4]. The move allows U.S. sunscreen formulations to align more closely with international standards [5].
Existing U.S. sunscreens often rely on older filters that may not provide the same breadth of protection as those available in other regions. By adding bemotrizinol, the FDA is introducing a filter that combines stability and efficacy, two critical factors in preventing skin cancer and premature aging [5].
“This is the first new sunscreen active ingredient added to the FDA’s monograph since the late 1990s.”
The approval of bemotrizinol signals an end to a multi-decade stagnation in U.S. sunscreen innovation. By adopting a filter already vetted by international regulators, the U.S. is closing a gap in public health protection, potentially offering consumers more effective broad-spectrum defense against UV radiation than was previously available under domestic regulations.
