Murali Matta, MPharm, PhD
Division of Applied Regulatory Science
Office of Clinical Pharmacology
Food and Drug Administration
Assessment of the Human Systemic Absorption of Sunscreen Active Ingredients: FDA-Sponsored Randomized Clinical Trial
FDA; Sunscreen; Randomized controlled trial; Regulatory; Data analysis
- The active ingredients in nonprescription sunscreen products are organic chemicals, some of which have been shown to be absorbed through human skin with detectable levels in the blood or urine.
- It is important that randomized clinical trials be conducted to better understand the clinical significance of systemic exposure to sunscreen products.
- In this trial, all active ingredients in all tested products exhibited systemic exposures above the threshold for potentially waiving some nonclinical toxicology studies for sunscreens.
Do the observed differences in the sunscreen concentration depend on the application type; for example, spray versus lotion versus cream?
While additional toxicology data are needed, the results of this study do not indicate that individuals should refrain from the use of sunscreen.
Is there opportunity for collaboration with other organizations including private physician-scientists to conduct larger population studies with consumers?
#pctGR, @Collaboratory1, @US_FDA