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1 July 20265 min read
Medicine
FDA Adds Bemotrizinol to US Sunscreen Rules After Decades Without a New Active Ingredient
The ultraviolet filter has been used internationally for years and can now be included in qualifying US over-the-counter sunscreens at concentrations of up to 6%.
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The US Food and Drug Administration has added bemotrizinol to the list of active ingredients permitted under the country's over-the-counter sunscreen monograph, the first addition of its kind since the late 1990s.
Bemotrizinol is an organic ultraviolet filter that protects against both UVA and UVB radiation. It has already been used in Europe and other markets for years, but US sunscreen regulation has historically offered manufacturers a narrower selection of filters.
The FDA considers the ingredient generally recognized as safe and effective for sunscreen use by adults and children aged six months and older. The administrative order permits concentrations of up to 6%, subject to the other formulation, testing and labelling requirements in the monograph.
According to the agency, available evidence indicates that bemotrizinol has low absorption through the skin and rarely causes irritation. The FDA finalized the change approximately seven months after issuing its proposed order. DSM Nutritional Products submitted the request that initiated the process.
The decision does not mean that every sunscreen containing the ingredient has received an individual FDA approval. Sunscreens covered by an OTC monograph may be marketed without a product-specific new drug application when they comply with the monograph's conditions.
Nor does the order make existing sun-protection advice obsolete. The FDA continues to recommend broad-spectrum sunscreen alongside protective clothing, shade and limits on exposure, particularly during periods of intense sunlight.
Why It Matters
American consumers have long had fewer modern sunscreen filters than consumers in many other markets. Bemotrizinol could give formulators more flexibility to produce broad-spectrum products with improved cosmetic characteristics, which may encourage consistent use. The regulatory route is also significant. This is the first sunscreen ingredient added through the streamlined OTC-monograph process created by the CARES Act. The speed and effectiveness of that process will influence whether other internationally used filters can reach the US market. Products will not necessarily appear immediately. Manufacturers must develop compliant formulations, perform required testing, arrange production and launch through retail channels.
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Topics
FDASunscreenDermatologyOTC RegulationCARES Act