RCT
Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients
Matta MK, Zusterzeel R, Pilli NR, Patel V, Volpe DA, Florian J, et al.
RCTJAMA2019n=24
Research Facts
Effect of Sunscreen Application Under Maximal Use Conditions on Plasma Concentration of Sunscreen Active Ingredients
Matta MK, Zusterzeel R, Pilli NR, Patel V, Volpe DA, Florian J, et al.
RCT ยท Strong ยท 2019
Findings

Four sunscreen active ingredients were absorbed systemically at plasma concentrations exceeding the FDA threshold for waiving additional safety studies

Design
RCT
Sample
n=24
Evidence
Strong
Journal
JAMA
Methodology

This FDA-conducted randomized clinical trial assigned 24 healthy volunteers to apply one of four commercially available sunscreen formulations (spray, lotion, or cream) under maximal use conditions (75% body surface area, four times daily). Blood samples showed that avobenzone, oxybenzone, octocrylene, and ecamsule all exceeded the FDA's 0.5 ng/mL threshold for systemic absorption after just one day of use. The study did not conclude that sunscreens are unsafe, but demonstrated that further safety studies are warranted. It was widely cited in debates about mineral vs. chemical sunscreen formulations.

Funded By

U.S. Food and Drug Administration

๐Ÿง‚Conflict of interest.