Author Interviews, Dermatology, Environmental Risks, FDA, JAMA / 06.05.2019
How Much of Your Sunscreen is Absorbed?
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. (more…)