Last summer (June 17th, 2011) the FDA published a final rule regarding labeling and effectiveness testing for over-the-counter sunscreen products, marketed without an approved application. The final rule and compliance guidelines (listed below) are fast approaching and go into effect on Monday, June 18, 2012, which is only 8 weeks away.
Consumers need to be aware that there is some lag time between the effective date of the new guidelines and what is available at your local pharmacy or sunscreen retailer. The FDA does not expect non-compliant products delivered or introduced prior to June 18, 2012, to be removed from the market. Therefore, product delivered to customers, even if they are in the manufacturers’ warehouse prior to the effective date, can continue to be shipped and sold. For products with annual sales of less than $25,000, the compliance date is extended to June 17, 2013.
Sunscreen in combination with other measures, including sun protective clothing can help prevent skin cancer and early skin aging. The new requirements are intended to assist consumers in making informed purchasing decisions and to avoid overvaluing the radiation protection provided by certain sunscreen products. For the greatest protection from your sunscreen, look for the following:
Broad Spectrum – indicates protection from UVA
Minimum of SPF 15 – indicates protection from UVB the sunburn causing rays (SPF does not give any indication of UVA protection).
The final rule includes the following requirements:
- Water resistance claims on the principal display panel must specify either 40 or 80 minutes of effectiveness while swimming or sweating, based on testing. “Waterproof,” “sweatproof,” and “sunblock” claims are not permitted.
- Claims that the product, in combination with other sun protection measure, reduces the risk of skin cancer and early skin aging are permitted only for broad spectrum products with SPF 15 and higher, and those concepts may also be reflected in the “Use” sections of these products’ Drug Facts boxes. Non-broad spectrum products and product with SPF values below 15 can only claim to prevent sunburn and must include a skin cancer/skin aging warning.
- All sunscreen products, including all cosmetic products making an SPF claim, must include the standard Drug Facts information. The only exception to his requirement under the final rule is the standard “small package” reduced labeling permitted by the Drug Facts rule.
Learn more about labeling requirements from our post FDA Updates Sunscreen Regulations.
Learn more about top rated sunscreens from the Environmeal Working Group.
Learn more about Coolibar Suncreens, which are all Broad Spectrum and SPF 30 or higher.