Dataset Information

Suboptimal UVA attenuation by broad spectrum sunscreens under outdoor solar conditions contributes to lifetime UVA burden.

ABSTRACT:

Background

Broad spectrum sunscreens with a sun protection factor (SPF) of 15 or greater are indicated to decrease the risk of skin cancer and early skin aging caused by the sun if used as directed with other sun protection measures. To determine whether sunscreen product performance is compromised under solar exposure and to test spectral uniformity of protection across the UVA spectrum, we tested broad spectrum sunscreens with a variety of active pharmaceutical ingredients (APIs) and in a variety of dosage forms.

Methods

A cross-sectional market survey of 32 sunscreen drug products containing either organic or inorganic APIs with SPFs of 15, 30, 50, and 70 was tested. UV doses were delivered via natural sun in Silver Spring, Maryland between June and September of 2017.

Results

Of the 32 sunscreen drug products, 6 products failed to meet their broad spectrum claim under solar exposure. Using FDA's new proposal to strengthen sunscreen broad spectrum requirements, spectral uniformity based on the mean sunscreen absorbance of UVA1(340-400 nm)/UV (290-400 nm) indicated that ~40% of sunscreen drug products tested had suboptimal UVA protection.

Conclusion

US consumers may unknowingly be receiving up to 36% more transmitted UVA when selecting between similarly labeled broad spectrum sunscreen drug products with equivalent SPF values. FDA's new proposal may help decrease consumers' overall lifetime UVA burden. Spectral absorbance data on sunscreen performance can be used to further improve the coupling of broad spectrum protection to a product's SPF value so that consumers have improved proportional increases in UV protection.

SUBMITTER: Coelho SG

PROVIDER: S-EPMC7853154 | biostudies-literature | 2020 Jan

REPOSITORIES: biostudies-literature

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Publications

Suboptimal UVA attenuation by broad spectrum sunscreens under outdoor solar conditions contributes to lifetime UVA burden.

Coelho Sergio G SG Rua Diego D Miller Sharon A SA Agrawal Anant A

Photodermatology, photoimmunology & photomedicine 20190916 1

<h4>Background</h4>Broad spectrum sunscreens with a sun protection factor (SPF) of 15 or greater are indicated to decrease the risk of skin cancer and early skin aging caused by the sun if used as directed with other sun protection measures. To determine whether sunscreen product performance is compromised under solar exposure and to test spectral uniformity of protection across the UVA spectrum, we tested broad spectrum sunscreens with a variety of active pharmaceutical ingredients (APIs) and i ...[more]

PMID: 31376300

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Project description:BackgroundOutdoor workers (OW) are highly exposed to solar ultraviolet radiation (UVR) and thus at increased risk for developing skin cancer. An essential part of an overall strategy to reduce workplace UVR-exposure to OW's skin is the usage of sunscreens. However, compliance with regular sunscreen usage seems to be low, as products are usually designed for recreational sun exposure and thus do not meet the requirements of physically active OW. To date, no standardized test procedures assess the suitability of sunscreens for professional use. The aim of this pilot study was to develop standardized methods of testing secondary performance attributes (PA) to represent real-life working conditions of outdoor work.MethodsTen sunscreen products, carefully selected after a detailed market survey of all relevant producers available on the German market, were evaluated regarding their suitability for professional outdoor work on 24 healthy volunteers in a newly designed test procedure. In addition to three standardized efficacy characteristics, i.e., sun protection factor, water-resistance, and UVA protection, we evaluated each PA involving parameters typically associated with outdoor workplaces.ResultsWe developed standardized methods for objectifying the suitability of sunscreen products for professional outdoor work. The test procedures used are well feasible and appropriate for testing the PA because they represent practical working conditions in detail - although the degree of discriminability of single test methods varied. The claimed sun protection factor (SPF) of the products was confirmed; bio-stability of the SPF after physical activity was achieved in most cases. While most products hardly irritate the eyes and are quickly absorbed, the evaluation of the subjective skin feeling and non-slip grip is inconsistent.ConclusionsIn this pilot study, for the first time secondary PA are defined and examined. Although further objectification of the PA assessment as well as the establishment of minimum standards should be sought, the new methods could already complement the so far mandatory labels and in this way provide a significant impetus for the current scientific and political focus on the improvement of occupational health in highly UVR-exposed OW.

Project description:IntroductionThis study explored a new method to test sunscreens in outdoor conditions (very high to extreme ultraviolet [UV] radiation) approximating real-life solar exposure while maintaining scientific standards and acceptable conditions, and assessed the efficacy of a water-based sun-protection factor (SPF) 50+ versus a reference SPF15 and two comparator SPF50+ products.MethodsThirty-five subjects underwent testing in summertime Mauritius. In each subject, five test areas were marked on the back. One area was left unprotected, and four sunscreens were applied to the others: investigational product (IP), SPF15 (ISO 24444:2010 reference standard P3), and two marketed SPF50+ controls. Subjects spent 1-2 h (depending on skin type) in the sun. After 24 h, erythema was assessed by clinical scoring (0-5) and colorimetry (a*, L*, and ITA). Secondary endpoints were correlation between clinical and colorimetry assessment, product tolerability, and total UV radiation received.ResultsAll subjects were exposed to a very high UV index (≥ 8) and 30/35 were exposed to an extreme UV index (≥ 11). The IP showed statistically significant differences in clinical erythema scoring compared with unprotected skin and SPF15, but not with SPF50+ controls. On colorimetry, differences in a* (redness) and L* (lightness) reached statistical significance for the IP vs SPF15 but not vs SPF50+ controls. Clinical and instrumental erythema assessment correlated strongly (Spearman's rho 0.663). No tolerability issues were reported.ConclusionThis exploratory study confirmed the ability of this outdoor model to discriminate sunscreens with different SPF using clinical evaluation as an objective measure. The water-based sunscreen maintained its efficacy in outdoor conditions of very high to extreme UV radiation: it was superior to SPF15 and comparable to SPF50+ controls in preventing erythema. The method used represents an option for sunscreen efficacy comparison outside of the laboratory.FundingIsdin.

Dataset Information

Suboptimal UVA attenuation by broad spectrum sunscreens under outdoor solar conditions contributes to lifetime UVA burden.

Background

Methods

Results

Conclusion

Publications

Suboptimal UVA attenuation by broad spectrum sunscreens under outdoor solar conditions contributes to lifetime UVA burden.

Similar Datasets

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