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FDA In Brief: FDA announces results from second sunscreen absorption study

January 21, 2020

Media Inquiries

  Amanda Turney
  301-796-2969

The following quote is attributed to Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

“Given the recognized public health benefits of sunscreen use, the U.S. Food and Drug Administration (FDA) urges Americans to use sunscreens in conjunction with other sun protective measures (such as protective clothing). To support sunscreen safety, the FDA tested whether various sunscreen ingredients can be absorbed through the skin into the body.”

“Results from our study released today show there is evidence that some sunscreen active ingredients may be absorbed. However, the fact that an ingredient is absorbed through the skin and into the body does not mean that the ingredient is unsafe, nor does the FDA seeking further information indicate such. Rather, this finding calls for further industry testing to determine the safety and effect of systemic exposure of sunscreen ingredients, especially with chronic use.”

“That’s why as part of the proposed rule on sunscreen, the FDA requested additional information on active ingredients in sunscreen to evaluate their GRASE (Generally Recognized As Safe and Effective) status in light of changed conditions, including substantially increased sunscreen usage and evolving information about the potential risks associated with these products since they were originally evaluated. We look to sharing further updates on this important area of research. ”

  • Today, the FDA published the study, “Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial” in the Journal of the American Medical Association (JAMA). This study describes the results of a clinical trial evaluating the absorption through the skin and into the body of six sunscreen active ingredients under single dose and maximal use conditions. The study included ingredients not previously evaluated. A prior pilot study was published in JAMA in May 2019.
  • The study used four commercially available sunscreen products (lotion, aerosol spray, non-aerosol spray and pump spray). The publication results show that when sunscreen is applied to the skin, even a single application, all six tested active ingredients and all of the formulations, result in measurable blood levels of the active ingredient.

Related Information

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

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