FDA Sunscreen Regulations

In 2012, the FDA passed new regulations regarding the labeling of sunscreen. Regulatory-compliant sunscreens, with proper labeling, are now available for over-the-counter consumer use.

Significant changes to how sunscreen may be advertised are listed below:

1. Broad spectrum designation: Sunscreens that pass the FDA’s broad spectrum test procedure, which measures UVA and UVB protection, will be labeled as "Broad Spectrum" and "SPF 15" (or higher) on the front label.  

2. Use claims: Only Broad Spectrum sunscreens with an SPF value of 15 or higher will be able to claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Sunscreens that are not "Broad Spectrum" or have a SPF value between 2 and 14 have only been shown to prevent sunburn. The labels of these products will include the following warning: 

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early aging. 

3. “Waterproof,” “sweatproof” or “sunblock” claims: According to the FDA, manufacturers cannot label sunscreens as “waterproof” or “sweatproof” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection immediately upon application or protection for more than two hours without reapplication.  

4. Water resistance claims: Water resistance [not proof] claims on the front label will indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating.   

5. Drug facts: All sunscreens will include standard “Drug Facts” information on the back and/or side of the container. 

 

For more information, see the FDA Consumer Sunscreen Labeling update.