The FDA proposed solar simulator versus sunlight

Area of Science:

• Photoprotection
• Dermatology
• Cosmetic Science

Background:

• The US Food and Drug Administration (FDA) is updating sunscreen regulations, including testing and labeling requirements.
• A European cosmetic trade association (COLIPA) proposed a solar simulator standard adopted by the FDA.
• Variability in solar simulators could impact the accuracy of sunscreen testing.

Purpose of the Study:

• To evaluate spectral data from solar simulators compliant with proposed FDA standards.
• To compare these simulators against standard solar spectra (Air Mass 1.0, 1.5, 2.0).
• To assess the consistency of results among compliant solar simulators.

Main Methods:

• Selected spectral data from multiple solar simulators meeting proposed FDA standards.
• Compared simulator spectra to standard solar spectra (AM1.0, AM1.5, AM2.0).
• Utilized spectral analysis, including goodness-of-fit tests against an AM1.0 spectrum.

Main Results:

• Goodness-of-fit between simulator and AM1.0 spectra ranged from 78% to 90%.
• Goodness-of-fit decreased when compared to AM1.5 and AM2.0 solar spectra.
• None of the analyzed solar simulators were predicted to yield the same SPF as natural sunlight.

Conclusions:

• Solar simulators compliant with the proposed FDA standard exhibit variability.
• The current standard may not guarantee consistent SPF measurements across different devices.
• Sunscreen SPF values obtained from these simulators may not accurately reflect real-world sun protection.