Analysis of "Broad Spectrum" UVA and UVB Components in Sun Care Products for Compliance with New FDA Regulations

June 1, 2012
Nonie Danna

,
PerkinElmer, Inc.

The Application Notebook

The Application Notebook, The Application Notebook-06-01-2012, Volume 0, Issue 0

The FDA has made changes to how products containing sunscreen are labeled in the U.S. to ensure they meet the new regulations set forth for safety and effectiveness. The new regulations will require companies that want to use the "broad spectrum" label to test for both UVA and UVB protection.

The FDA has made changes to how products containing sunscreen are labeled in the U.S. to ensure they meet the new regulations set forth for safety and effectiveness. The new regulations will require companies that want to use the "broad spectrum" label to test for both UVA and UVB protection. Previous regulations only dealt with preventing sunburn which is primarily due to UVB radiation but did not address UVA which protects against early aging and skin cancer. All products that claim to provide broad spectrum SPF protection are regulated as sunscreen products. Therefore, the regulations the FDA has developed for over the counter (OTC) sunscreen products apply to cosmetics, moisturizers, lip balms, and shampoos labeled with SPF values.

Table I: Experimental Conditions

Results

Conclusion

The methodology in Figure 1 provides one test method to determine both UVA and UVB compounds most commonly used in the sun care industry. Figure 2 is a sun care spray run with the same analytical conditions eluting six UVA/B compounds. All UVB and UVA compounds are eluted in a single run and can be quantitated in the ranges recommended by the FDA (SPF 15–50+). Only broad spectrum products with an SPF value of 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures.

Figure 1: All UVA and UVB compounds are eluted in a single run using a Brownlee SPP column with an optimized PerkinElmer HPLC system

Figure 2: SPF 50 sun care spray shows elution of both UVA/B compounds.

References

(1) U.S. Food and Drug Administration, 2012. Information for Consumers, 2012. Retrieved from http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/UnderstandingOver-the-CounterMedicines/ucm258468.htm.

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