Application note - Liquid Chromatography - Components in Sun Care Products for Compliance with New FDA Regulations

The Food and Drug Administration (FDA) has made changes to how products containing sunscreen are labeled in the U.S.A 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’s standardized test for broad spectrum enables consumers to determine the level of UVA protection a sunscreen provides in addition to its ultraviolet B (UVB) radiation protection. Previous rules 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. These new testing and labeling requirements are necessary to educate consumers and provide information for consumers to make knowledgeable choices. 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.