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Sunscreen Protection and Federal Regulations

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In his session at Maui Derm Hawaii 2023, Curtis Cole, PhD, President of Sun & Skin Consulting, LLC, detailed the limitations facing the US Sunscreen industry.

The US Food and Drug Administration (FDA) regulates sunscreens, to ensure consumers have access to safe and effective sun protection products. However, in his session “Photoprotection: Light and Skin” at Maui Derm Hawaii 2023, Curtis Cole, PhD, President of Sun & Skin Consulting, LLC, said federal regulators need to do more, when it comes to nonprescription protection from ultra-violet rays.

“We’ve had no new approval of sunscreen filters in 20 years. We are third- world country when it comes to sunscreens” Cole stated. He specified that we are behind other global communities, including Australia, Europe, Asia and Canada, who all have more effective formulas than the US.1

The newest data from the National Cancer Institute indicates the rate of new melanoma cases among American adults has tripled since the 1970s, from 7.9 per 100,000 people in 1975 to 23.9 per 100,000 in 2019. Research indicates that contributing factors include ultraviolet radiation and sunburns. 2

Most evaluations of sunscreen efficacy focus primarily on skin redness, or sunburn, caused by UVB rays. Cole indicated that sunscreen manufacturers are running out of options due to a series of government regulations:

  1. The FDA has categorized all organic UV filters as category III, insufficient data for categories such as Generally recognized as safe and effective (GRASE).
  2. FDA does not permit inorganic filters (ZnO and TiO2 to be combined with avobenzone.
  3. States and countries are banning sales of sunscreens with organic filters.
  4. Environmental concerns regarding organic and inorganic filters.

These factors, said Cole, provide the US sunscreen industry very limited options to achieve effective sun protection for consumers.

Cole concluded by asking the dermatology community to help by

  • Supporting and promoting the use of all approved sunscreen filters (organic and inorganic)
  • Supporting and promoting awareness of the safety of existing UV filters (organic and inorganic)
  • Supporting the FDA approvals for filters available in other global communities.

References

1. Cole, C. Photoprotection: Light and Skin; Presented at Maui Derm Hawaii 2023; January 23-27, 2023; Maui, Hawaii.

2. American Cancer Society. Melanoma Skin Cancer. Accessed January 26, 2023. https://www.cancer.org/cancer/melanoma-skin-cancer/about/key-statistics.html

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