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What is the maximum plasma concentration of active ingredients of various types of sunscreen formulations under maximal use conditions?
In this randomized clinical trial that included 24 healthy participants and application of 4 commercially available sunscreen formulations, maximum plasma concentrations (geometric mean [coefficient of variation]) for the active ingredient avobenzone were 4.0 (60.9%), 3.4 (77.3%), 4.3 (46.1%), and 1.8 (32.1%) ng/mL for 2 different sprays, a lotion, and a cream, respectively.
The systemic absorption of sunscreen active ingredients supports the need for further studies to determine the clinical significance of these findings.
The US Food and Drug Administration (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.
To determine whether the active ingredients (avobenzone, oxybenzone, octocrylene, and ecamsule) of 4 commercially available sunscreens are absorbed into systemic circulation.
Design, Setting, and Participants
Randomized clinical trial conducted at a phase 1 clinical pharmacology unit in the United States and enrolling 24 healthy volunteers. Enrollment started in July 2018 and ended in August 2018.
Participants were randomized to 1 of 4 sunscreens: spray 1 (n = 6 participants), spray 2 (n = 6), a lotion (n = 6), and a cream (n = 6). Two milligrams of sunscreen per 1 cm2 was applied to 75% of body surface area 4 times per day for 4 days, and 30 blood samples were collected over 7 days from each participant.
Main Outcomes and Measures
The primary outcome was the maximum plasma concentration of avobenzone. Secondary outcomes were the maximum plasma concentrations of oxybenzone, octocrylene, and ecamsule.
Among 24 participants randomized (mean age, 35.5 [SD, 1.5] years; 12 (50%] women; 14 [58%] black or African American; 14 [58%]), 23 (96%) completed the trial. For avobenzone, geometric mean maximum plasma concentrations were 4.0 ng/mL (coefficient of variation, 6.9%) for spray 1; 3.4 ng/mL (coefficient of variation, 77.3%) for spray 2; 4.3 ng/mL (coefficient of variation, 46.1%) for lotion; and 1.8 ng/mL (coefficient of variation, 32.1%). For oxybenzone, the corresponding values were 209.6 ng/mL (66.8%) for spray 1, 194.9 ng/mL (52.4%) for spray 2, and 169.3 ng/mL (44.5%) for lotion; for octocrylene, 2.9 ng/mL (102%) for spray 1, 7.8 ng/mL (113.3%) for spray 2, 5.7 ng/mL (66.3%) for lotion, and 5.7 ng/mL (47.1%) for cream; and for ecamsule, 1.5 ng/mL (166.1%) for cream. Systemic concentrations greater than 0.5 ng/mL were reached for all 4 products after 4 applications on day 1. The most common adverse event was rash, which developed in 1 participant with each sunscreen.
Conclusions and Relevance
In this preliminary study involving healthy volunteers, application of 4 commercially available sunscreens under maximal use conditions resulted in plasma concentrations that exceeded the threshold established by the FDA for potentially waiving some nonclinical toxicology studies for sunscreens. The systemic absorption of sunscreen 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.
ClinicalTrials.gov Identifier: NCT03582215
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Corresponding Author: David G. Strauss, MD, PhD, Division of Applied Regulatory Science, Office of Clinical Pharmacology, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration, 10903 New Hampshire Ave, WO64-2072, Silver Spring, MD 20993 (email@example.com).
Accepted for Publication: April 12, 2019.
Published Online: May 6, 2019. doi:10.1001/jama.2019.5586
Author Contributions: Drs Matta and Strauss had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Matta, Zusterzeel, Patel, Oh, Bashaw, Zineh, Sanabria, Adah, Coelho, Wang, Furlong, Ganley, Michele, Strauss.
Acquisition, analysis, or interpretation of data: Matta, Zusterzeel, Pilli, Patel, Volpe, Florian, Kemp, Godfrey, Wang, Michele, Strauss.
Drafting of the manuscript: Matta, Zusterzeel, Sanabria, Strauss.
Critical revision of the manuscript for important intellectual content: Matta, Zusterzeel, Pilli, Patel, Volpe, Florian, Oh, Bashaw, Zineh, Kemp, Godfrey, Adah, Coelho, Wang, Furlong, Ganley, Michele, Strauss.
Statistical analysis: Matta, Zusterzeel, Florian, Wang.
Obtained funding: Wang, Michele, Strauss.
Administrative, technical, or material support: Matta, Zusterzeel, Pilli, Patel, Bashaw, Zineh, Kemp, Adah, Coelho, Wang.
Supervision: Patel, Sanabria, Wang, Furlong, Ganley, Michele, Strauss.
Conflict of Interest Disclosures: None reported.
Funding/Support: The study was funded by the US Food and Drug Administration.
Role of the Funder/Sponsor: The FDA oversaw the design and overall conduct of the study including overseeing the management, analysis, and interpretation of the data. The FDA also prepared, reviewed, and approved the manuscript for submission for publication.
Additional Contributions: We are deeply grateful to the study participants and all the nurses and physicians from Spaulding Clinical Research who contributed to the dosing and pharmacokinetic sample collection. We also thank Robert Gump, BS (FDA), and Suresh Narayanasamy, PhD (FDA), who performed this work as a part of their normal duties.
Data Sharing Statement: See Supplement 4.
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