MedicalResearch.com Interview with:
David Strauss, MD, PhD
Director, Division of Applied Regulatory Science
U.S. Food and Drug Administration
Center for Drug Evaluation and Research
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: It is unknown whether most active ingredients in sunscreens are absorbed. FDA has provided guidance that sunscreen active ingredients with systemic absorption greater than 0.5 ng/mL or with safety concerns should undergo nonclinical toxicology assessment including systemic carcinogenicity and additional developmental and reproductive studies.
This randomized clinical trial demonstrated systemic exposure of 4 commonly used sunscreen active ingredients on application of sunscreen products under maximal use conditions consistent with current sunscreen labeling.
All 4 sunscreen active ingredients tested resulted in exposures exceeding 0.5 ng/mL.
MedicalResearch.com: What should readers take away from your report?
Response: The systemic absorption of sunscreen active ingredients supports the need for further studies to determine the clinical significance of these findings. These results do not indicate that individuals should refrain from the use of sunscreen. While further data on sunscreens are developed, consumers should continue to use sunscreens with other sun protective measures.
MedicalResearch.com: What recommendations do you have for future research as a result of this work?
Response: A second phase of this study will use a different design to investigate additional questions raised by this study, including the maximum plasma concentration after a single application, the skin concentration during the washout phase, the plasma concentration up to 17 days after the last dose, and the systemic exposure to additional commonly used sunscreen ingredients. In addition, larger “maximal usage trials” are needed to better delineate the absorption of sunscreen active ingredients over the larger population that uses sunscreens.
Finally, nonclinical toxicology studies are warranted that include systemic carcinogenicity and additional developmental and reproductive studies.
MedicalResearch.com: Is there anything else you would like to add?
Response: These results do not indicate that individuals should refrain from the use of sunscreen. While further data on sunscreens are developed, consumers should continue to use sunscreens with other sun protective measures. Broad spectrum sunscreens with SPF values of at least 15 remain a critical element of a skin-cancer prevention strategy that includes other sun protective behaviors such as wearing protective clothing that adequately covers the arms, torso, and legs; wearing sunglasses and a hat that shades the whole head; and seeking shade whenever possible during periods of peak sunlight.
Matta MK, Zusterzeel R, Pilli NR, et al. Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial. JAMA. Published online May 06, 2019. doi:10.1001/jama.2019.5586
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