FDA Announces New Requirements for Labeling of OTC Sunscreen Products in the USA

• By: Staff Editor
• Date: June 18, 2011

More than three decades after sunscreen labeling requirements were first introduced, the FDA announced these updates that will boost its efforts to ensure that sunscreens “meet modern-day standards for safety and effectiveness”. The previous labeling used in OTC sunscreens dealt almost exclusively with protection against sunburns caused primarily by ultraviolet B (UVB) radiation from the sun. The labels did not address the more dangerous ultraviolet A (UVA) radiation which contributes to skin cancer and early skin ageing.

According to the Skin Cancer Foundation, more than 3.5 million skin cancers are diagnosed in over two million Americans each year. One in five Americans will develop skin cancer during his or her lifetime. Of these cancers, about 90 percent of nonmelanoma skin cancers are associated with too much exposure to ultraviolet (UV) radiation from the sun.

These sobering statistics have driven the FDA to implement stricter and clearer regulations regarding over-the-counter sunscreens sold across the United States.

The FDA did a review of the latest science and decided that sufficient data was available to establish a “broad spectrum” test for determining a sunscreen product’s UVA protection. If the product passed this broad spectrum test, it would be able to provide UVA protection that is proportional to its UVB protection. Those sunscreens that pass this broad spectrum test will be allowed to be labeled as “Broad Spectrum” that protects against both UVA and UVB rays. The FDA has stated that these new testing and labeling requirements are necessary to provide consumers with the information need to make informed choices when selecting sunscreens.

The new FDA final rule that will come into force by summer 2012 includes the following requirements:

• Designating Sunscreens as Broad Spectrum – Products that pass the FDA’s broad spectrum test procedure will be deemed to protect the user against both UVA and UVB solar radiation. These products can be labeled as "Broad Spectrum SPF [value]" on the front label. Broad Spectrum SPF 15 and higher values are deemed to provide greater protection and may claim additional uses such as those explained below.
• Additional Claims on Product Labels – Only those Broad Spectrum sunscreens with SPF values of 15 and higher can claim to reduce the risk of skin cancer and early skin ageing if used as directed with other sun protection measures on their labels. Non-Broad Spectrum sunscreens and Broad Spectrum sunscreens with SPF values between 2 and 14 can no longer claim to protect against the risk of skin cancer and can only claim to help prevent sunburn.
• No more “Waterproof”, “Sweatproof” or “Sunblock” Claims – Sunscreen manufacturers can no longer label and market their products as “waterproof”, “sweatproof” or call their products “sunblocks” because these claims have been discredited through extensive testing. The products can also not claim more than two hours of sun protections without reapplication or to provide protection immediately after application (claims such as “instant protection”) without submitting test data that support these claims to the FDA and obtain its approval.
• Water Resistance Claims – Water resistance claims on the front label of the product must indicate whether the sunscreen remains effective for 40 or 80 minutes while swimming or sweating, based on standard testing. Sunscreens that are not water resistant must include a direction instructing consumers to use a water resistant sunscreen if swimming or sweating.
• Drug Facts – All sunscreens must include standard “Drug Facts” information on the back and/or side of the container.

The FDA has also formulated a proposed rule, which if finalized, would limit the maximum SPF value on sunscreen labels to "50 +". The agency says that there is not enough scientific data to show that products with SPF values higher than 50 provide greater protection for users than products with SPF values of 50.

Reaction to the new FDA requirements has mostly been positive. Dermatologists, skin cancer specialists, healthcare advocates and consumer rights protections groups have believed the new standards to be long overdue in light of the increasing rates of skin cancer in the country. The American Academy of Dermatology Association (Academy), which plays a major role in formulating policies that can enhance the quality of dermatologic care, released a statement praising the new FDA regulations.  "For the first time, the FDA has clearly defined the testing required to make a broad-spectrum protection claim in a sunscreen and indicate which type of sunscreen can reduce skin cancer risk," said dermatologist Ronald L. Moy, MD, FAAD, president of the Academy.

Additional Resources

• For more information about the FDA’s new sunscreen labeling and marketing requirements, please click here.
• FDA Final Rule: Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use