FDA Issues New Sunscreen Safety Regulation Requirements

The process of deciding between different brands of sunscreen can be somewhat overwhelming. Consumers are often left wondering what various claims on sunscreen labels mean and whether the sunscreen they are choosing will actually keep them safe from sunburn and skin cancer.

In June 2011 the FDA published new rules, to take effect in June 2012, which will govern sunscreen testing and labeling. The aim of the new rules is to reduce consumer confusion and ensure that sun protection products on the market meet safety standards for effectiveness based on the latest possible scientific information.

“Broad Spectrum” Labels

One of the main objectives of the new FDA rules is to inform consumers about sun protection product’s ability to block UVA and UVB rays. UVB rays cause sunburn. Both types cause skin cancer but UVA rays are more commonly linked with cancer. Currently, FDA rules only require sunscreen manufacturers to test protection against UVB rays and the results of those tests are the basis for the SPF numbers that sunscreens use. Under the new rules, only sunscreens that block UVA and UVB sun rays equally will qualify to claim they offer “broad spectrum” protection.

No More “Sweatproof” or “Waterproof”

The new rules eliminate the labels “sweatproof” and “waterproof” on sunscreens because such claims are false. Instead, manufacturers will have to print the number of minutes for which their product is water-resistant.

Warning Labels and Claims of Protection

After the new rules go into effect, only manufacturers of sunscreens with an SPF of 15 or higher that protect against both UVA and UVB rays will be able to claim on labels that they protect against sunburn, skin aging and skin cancer. Those sunscreens with an SPF of lower than 15 will need to carry the warning label stating “”This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.”

Drug Facts

All sunscreens will now have to place a “Drug Facts” label on the back or side of the package similar to other over the counter drugs that inform consumers of the ingredients and their functions.

With an estimated 68,130 new melanoma cases and 8,700 fatalities from skin cancer in the U.S. in 2010 according to the National Cancer Institute, the importance of having accurate information regarding sunscreen protection is clear. Consumers will now be able to make more informed choices and protect themselves more easily.