FDA proposes first new sunscreen filter in 26 years
AADA advocacy paved the way for proposed innovative sunscreen ingredients
This message was republished from recent article from the American Academy of Dermatology.
The American Academy of Dermatology Association applauds the Food and Drug Administration (FDA) for proposing to add a new sunscreen ingredient, bemotrizinol (BEMT) as a permitted active ingredient for use in sunscreens. If approved, this new sunscreen ingredient will expand the sunscreen options available to the public and greatly benefit public health.
The FDA announcement follows longstanding and ongoing advocacy by the Academy to ensure that consumers have options to protect themselves from UV exposure. For instance, the AADA successfully advocated for the FDA’s OTC user fee program, to include increased innovation and access to OTC products like the approval of new sunscreens. This legislation streamlined the FDA’s review process for assessing the safety and effectiveness of new ingredients used in over-the-counter sunscreens.
Simultaneously, the Academy has consistantly urged the FDA to include innovative sunscreen filters and it is encouraged that the FDA is taking the first step towards approving an innovative sunscreen filter as an active ingredient.
The new proposed filter is an oil-soluble organic compound that provides low-level skin absorption and provides broad spectrum protection to absorb UV rays, absorbing both UVB and UVA rays. If approved, the proposed BEMT filter would be the third sunscreen active ingredient (in addition to zinc oxide and titanium dioxide) to be generally recognized as safe and effective for use by adults and children 6 months of age and older.
The proposed BEMT filter has already been approved in Europe since 2000. The FDA has approved 16 UV filters over the years, the last one in 1999.
The Academy hopes this proposed sunscreen filter is an indicator that the FDA is poised to move forward with lagging approvals of innovative and new sunscreen ingredients – many of which are available to consumers abroad – that will help save the lives of Americans from skin cancer.
Currently the FDA is seeking public comments on the new filter, and the AADA will review and submit its feedback.
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