Clinical Trial Looks at Absorption Levels of Sunscreen Active Ingredients into Bloodstream

JAMA

EMBARGOED FOR RELEASE: 11 A.M. (ET), MONDAY, MAY 6, 2019

Media advisory: To contact corresponding author David G. Strauss, M.D., Ph.D., email Sandy Walsh at Sandy.Walsh@fda.hhs.gov. The full study and editorial are linked to this news release and a visual abstract is below.

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Bottom Line: The U.S. Food and Drug Administration recommends that active ingredients in sunscreen absorbed into the bloodstream above a certain level undergo toxicology testing. Researchers from the FDA conducted this small randomized clinical trial of 24 healthy volunteers to determine bloodstream concentrations of four active ingredients (avobenzone, oxybenzone, octocrylene and ecamsule) in four sunscreens applied four times per day for four days with blood samples collected from study participants over seven days. Researchers report that all four active ingredients were found in blood samples at levels exceeding the threshold recommended for toxicology testing. The effect of these concentrations is unknown and further studies are needed to determine the clinical significance of these findings. Some limitations of this clinical trial include that it was conducted under indoor conditions without exposure to heat, sunlight or humidity, which may affect the rate of sunscreen absorption, and the study wasn’t designed to look at differences in absorption by the type of sunscreen formulation, skin type or age of the user. Researchers emphasize that their results don’t suggest people refrain from using sunscreen, which prevents skin damage.

Authors: David G. Strauss, M.D., Ph.D., U.S. Food and Drug Administration, Silver Spring, Maryland, and coauthors

(doi:10.1001/jama.2019.5586)

Editor’s Note: The article includes funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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