Cited by 298Skin Protection and AgingContact Dermatitis and AllergiesEffects and risks of endocrine disrupting chemicals

Effect of Sunscreen Application on Plasma Concentration of Sunscreen Active Ingredients: A Randomized Clinical Trial

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Matta, Murali K., Florian, Jeffry, Zusterzeel, Robbert, Pilli, Nageswara R., Patel, Vikram, Volpe, Donna A., Yang, Yang, Oh, Luke +12 more·2020·JAMA

Abstract

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- and maximal-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 outcome was the maximum plasma 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] years; 24 women [50%]; 23 white [48%], 23 African American [48%], 1 Asian [2%], and 1 of unknown race/ethnicity [2%]), 44 (92%) completed the trial. Geometric mean maximum plasma concentrations of all 6 active ingredients were greater than 0.5 ng/mL, and this threshold was surpassed on day 1 after a single application for all active ingredients. For avobenzone, the overall maximum plasma concentrations were 7.1 ng/mL (coefficient of variation [CV], 73.9%) for lotion, 3.5 ng/mL (CV, 70.9%) for aerosol spray, 3.5 ng/mL (CV, 73.0%) for nonaerosol spray, and 3.3 ng/mL (CV, 47.8%) for pump spray. For oxybenzone, the concentrations were 258.1 ng/mL (CV, 53.0%) for lotion and 180.1 ng/mL (CV, 57.3%) for aerosol spray. For octocrylene, the concentrations were 7.8 ng/mL (CV, 87.1%) for lotion, 6.6 ng/mL (CV, 78.1%) for aerosol spray, and 6.6 ng/mL (CV, 103.9%) for nonaerosol spray. For homosalate, concentrations were 23.1 ng/mL (CV, 68.0%) for aerosol spray, 17.9 ng/mL (CV, 61.7%) for nonaerosol spray, and 13.9 ng/mL (CV, 70.2%) for pump spray. For octisalate, concentrations were 5.1 ng/mL (CV, 81.6%) for aerosol spray, 5.8 ng/mL (CV, 77.4%) for nonaerosol spray, and 4.6 ng/mL (CV, 97.6%) for pump spray. For octinoxate, concentrations were 7.9 ng/mL (CV, 86.5%) for nonaerosol spray and 5.2 ng/mL (CV, 68.2%) for pump spray. The most common adverse event was rash, which developed in 14 participants. Conclusions and Relevance: In this study conducted in a clinical pharmacology unit and examining sunscreen application among healthy participants, all 6 of the tested active ingredients administered in 4 different sunscreen formulations were systemically absorbed and had plasma concentrations that surpassed the FDA threshold for potentially waiving some of the additional safety studies for sunscreens. These findings do not indicate that individuals should refrain from the use of sunscreen. Trial Registration: ClinicalTrials.gov Identifier: NCT03582215.

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  • A 2020 study of 48 randomized participants applying 2 mg/cm2 of sunscreen product to 75% of body surface areas between one and four times per day for 4 days demonstrated systemic absorption of avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate.

    “This 2020 study of 48 randomized participants applying 2 mg/ cm 2 of sunscreen product to 75% of body surface areas between one and four times per day for 4 days demonstrated systemic absorption of avobenzone, oxybenzone, octocrylene, homosalate, octisalate, and octinoxate [51].”

    From Sunscreens and Photoaging: A Review of Current Literature (2021) · cites this paper as [51]

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Authors
Matta, M. K., Florian, J., Zusterzeel, R., Pilli, N. R., Patel, V., Volpe, D. A., Yang, Y., Oh, L., Bashaw, E., Zineh, I., Sanabria, C., Kemp, S., Godfrey, A., Adah, S., Coelho, S., Wang, J., Furlong, L.-A., Ganley, C., Michele, T., & Strauss, D. G.
Affiliations
  • United States Food and Drug Administration (US)
  • Spaulding Clinical Research (United States) (US)
Corresponding author
Strauss, David G.
Venue
JAMA
Published
2020-01-21
Volume
323
Issue
3
Pages
256
ISSN
  • 0002-9955 (ISSN-L)
  • 0098-7484
OpenAlex
W3002374204
Cited by
298
References
5
Citations by year
2026: 49 · 2025: 48 · 2024: 57 · 2023: 35 · 2022: 43 · 2021: 40 · 2020: 25 · 2019: 1
FWCI
26.11
Type
journal article
Language
en
Open access
Locations
  • JAMA (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Topics
  • Health Sciences › Medicine › Dermatology › Skin Protection and Aging
  • Health Sciences › Medicine › Dermatology › Contact Dermatitis and Allergies
  • Physical Sciences › Environmental Science › Health, Toxicology and Mutagenesis › Effects and risks of endocrine disrupting chemicals
Keywords
sunscreen active ingredients, systemic absorption, plasma concentration, pharmacokinetics, avobenzone, benzophenone-3, octocrylene, homosalate, octinoxate, sunscreen formulation, photoprotection, skin cancer prevention, sunscreen safety
MeSH terms
Acrylates, Adult, Benzophenones, Cinnamates, Female, Humans, Male, Middle Aged, Propiophenones, Salicylates, Skin Absorption, Sunscreening Agents

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