Effect of Sunscreen Application on Plasma Concentration
of Sunscreen Active Ingredients
A Randomized Clinical Trial
Murali K. Matta, PhD; Jeffry Florian, PhD; Robbert Zusterzeel, MD, PhD, MPH; Nageswara R. Pilli, PhD; Vikram Patel, PhD; Donna A. Volpe, PhD;
Yang Yang, PhD; Luke Oh, PhD; Edward Bashaw, PharmD; Issam Zineh, PharmD, MPH; Carlos Sanabria, MD; Sarah Kemp, RN; Anthony Godfrey, PharmD;
Steven Adah, PhD; Sergio Coelho, PhD; JianWang, PhD; Lesley-Anne Furlong, MD; Charles Ganley, MD; Theresa Michele, MD; David G. Strauss, MD, PhD
IMPORTANCE A prior pilot study demonstrated the systemic absorption of 4 sunscreen active
ingredients; additional studies are needed to determine the systemic absorption of additional
active ingredients and how quickly systemic exposure exceeds 0.5 ng/mL as recommended
by the US Food and Drug Administration (FDA).
OBJECTIVE To assess the systemic absorption and pharmacokinetics of the 6 active
ingredients (avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate)
in 4 sunscreen products under single- andmaximal-use conditions.
DESIGN, SETTING, AND PARTICIPANTS Randomized clinical trial at a clinical pharmacology unit
(West Bend, Wisconsin) was conducted in 48 healthy participants. The study was conducted
between January and February 2019.
INTERVENTIONS Participants were randomized to 1 of 4 sunscreen products, formulated as
lotion (n = 12), aerosol spray (n = 12), nonaerosol spray (n = 12), and pump spray (n = 12).
Sunscreen product was applied at 2 mg/cm2 to 75% of body surface area at 0 hours on day 1
and 4 times on day 2 through day 4 at 2-hour intervals, and 34 blood samples were collected
over 21 days from each participant.
MAIN OUTCOMES AND MEASURES The primary outcomewas themaximumplasma
concentration of avobenzone over days 1 through 21. Secondary outcomes were the
maximum plasma concentrations of oxybenzone, octocrylene, homosalate, octisalate, and
octinoxate over days 1 through 21.
RESULTS Among 48 randomized participants (mean [SD] age, 38.7 [13.2] y