New US Labeling Rules for Sunscreens

On June 14, 2011, the Food and Drug Administration (FDA) announced significant changes to the labeling rules for sunscreen products. The changes are intended to provide better information to consumers for the purchase and use of sunscreens, and to allow them to more effectively protect themselves and their families from sun-induced damage. The rules include warning label requirements and definitions and go into effect on June 18, 2012.

Key Points of Rules
All sunscreen products are considered over-the-counter (OTC) products and are required to be in the “Drug Facts” format.

> The FDA states that a sunscreen must protect equally against both types of sun radiation (UVB and UVA) to be considered “broad spectrum.” Broad Spectrum sunscreens with an SPF value 15 or higher can claim to reduce the risk of skin cancer and early skin aging if used as directed with other sun protection measures. Non-Broad Spectrum sunscreens, and Broad Spectrum sunscreens with an SPF value lower than 15, can only claim to “help prevent sunburn.”

> Any sunscreen product that is not Broad Spectrum, or that is Broad Spectrum with an SPF value less than 15, requires a warning statement. The wording of this warning has been revised to state, ‘‘Skin Cancer/Skin Aging Alert: [in bold font] 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 [in bold font] skin cancer or early skin aging.’’

> The rules also ban manufacturers from claiming that their sunscreens are waterproof or sweatproof. This is due to the fact that these claims are misleading and false. However, sunscreens can claim to be “Water Resistant.” If that term is used, it is required to be on the front label and must indicate whether the sunscreen remains effective for 40 minutes or 80 minutes while swimming or sweating, based on standard testing.

How Can Bureau Veritas Help?
Bureau Veritas can test sunscreens for labeling, physical characteristics, and active ingredients verification. If you need assistance related to sunscreens or have questions on any other health and beauty products, please contact your customer service representative or email: Customer.SupportServices@us.bureauveritas.com.

Keep Up-to-Date with Bureau Veritas

Keep informed on regulatory changes, upcoming events, webinars and more, by subscribing to Bureau Veritas Bulletin and Event announcements...Click to Subscribe

Bureau Veritas Consumer Products Services, Inc. ("BVCPS") provides the information in this client bulletin as a resource of general information. It does not replace any applicable legal or regulatory requirements and is provided "as is." BVCPS will not be liable for any indirect, special, punitive, consequential or other damages (including without limitation lost profits) of any kind in connection with this client bulletin. BVCPS DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE, IN CONNECTION WITH THIS CLIENT BULLETIN.