News Release 

Study assesses absorption, blood levels of active ingredients in sunscreen

JAMA

Bottom Line: A randomized clinical trial with 48 healthy volunteers assessed the absorption of six active ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate and octinoxate) in four sunscreen products formulated as lotion and sprays (aerosol, nonaerosol and pump). This study builds on a prior trial from Food and Drug Administration (FDA) researchers published by JAMA in 2019. In this trial, all six tested active ingredients administered in four different sunscreen formulations were absorbed and had blood concentrations that surpassed the FDA threshold for potentially waiving some of the additional safety studies for sunscreens. Researchers emphasize the findings don't mean people should refrain from using sunscreen, which can help to prevent skin cancer and protect the skin. More research is needed to determine the effect of exposure to sunscreen ingredients. This study was conducted indoors in a clinical research setting and participants weren't exposed to direct sunlight during the seven days they remained at the clinic. A change in study design from an indoor to an outdoor setting would better represent real-life sunscreen application. The study also wasn't designed to assess the absorption difference by formulation or skin types.

To access the embargoed study: Visit our For The Media website at this link https://media.jamanetwork.com/

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

(doi:10.1001/jama.2019.20747)

Editor's Note: The study was funded by the FDA. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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Media advisory: To contact corresponding author David G. Strauss, M.D., Ph.D., email Amanda Turney at Amanda.Turney@fda.hhs.gov and Brittney Manchester at brittney.manchester@fda.hhs.gov. The full study and editorial are linked to this news release.

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