FDA Issues New Sunscreen Labeling Rules

The US Food and Drug Administration (FDA) has issued its long-awaited new rules for sunscreen labeling enabling consumers to more easily identify sunscreens that offer safe, effective protection from the sun’s cancer-causing ultraviolet (UV) radiation.

For the first time, the rules will include testing and labeling requirements for protection against the sun’s ultraviolet A (UVA) rays. Sunscreens that meet FDA standards for both ultraviolet B (UVB) and UVA protection may be termed “broad-spectrum,” a term that, until now, was frequently used but had no official meaning. Newly standardized methods for measuring UVA protection have made these improvements possible.

At the June 14, 2011 press conference, the FDA’s Director of the Center for Drug Evaluation and Research, Janet Woodcock, MD, announced that broad- spectrum sunscreens with an SPF (sun protection factor, a measurement of protection against UVB rays) of 15 or higher will be able to state, “If used as directed with other sun protection measures, this product reduces the risk of skin cancer and early skin aging, as well as helps prevent sunburn.” Sunscreen manufacturers have never before been able to make such a claim.

Here are the main points in the FDA’s new sunscreen rules:

• Sunscreens may be labeled “broad- spectrum” if they provide protection against both UVA and UVB radiation according to FDA-sanctioned test methods.

• Only broad-spectrum sunscreens with an SPF of 15 or higher may state that they protect against skin cancer if used as directed with other sun protection measures.

• Broad-spectrum sunscreens with SPFs of 2-14 must display a warning that the product has not been shown to help prevent skin cancer or early skin aging.

• The terms “sunblock,” “sweatproof” and “waterproof” are no longer allowed on sunscreen labels.

• Sunscreens may claim to be “water-resistant,” but must specify whether they protect the skin for 40 or 80 minutes of swimming or sweating, based on standard testing. Sunscreens that are not water-resistant must instruct consumers to use a water-resistant sunscreen if swimming or sweating.

• A company cannot claim that its sunscreen products provide sun protection for more than two hours without submitting test results to prove this.

In response to separate questions about the safety of certain sunscreen ingredients, Dr. Woodcock affirmed that the ingredients in sunscreens marketed today have been in use for many years, and there is no reason to believe that they are not safe for consumer use. 

Update (5/11/2012): The FDA has announced that it is giving sunscreen manufacturers an additional six months of time to implement the new regulations, which will now go into effect in mid-December 2012. Products grossing under $25,000 in sales now have until December 2013.

Sunscreen Labeling According to 2011 Final Rule

If used as directed with other sun protection measures, this product reduces the risk of skin cancer and early skin aging, as well as helps prevent sunburn.

Only products labeled both Broad Spectrum AND SPF15 or higher have been shown to provide all these benefits.

Published on August 24, 2011