The FDA made changes to the way sunscreens are marketed in the U.S., and its important (especially for us island dwellers) to know what these changes mean. The Final Rule took effect this summer.
What is Broad Spectrum?
Since older rules mainly dealt with the cause of sunburn, ultraviolet B (UVB) radiation from the sun, measures were taken to include ultraviolet A (UVA) radiation, which contributes to skin cancer and early aging to the rules. To test the sunscreen’s ability to prevent UVA radiation, the broad spectrum test was created. Passing the broad spectrum test shows that the product provides UVA protection that is proportional to its UVB protection. If a sunscreen product passes the broad spectrum test, the bottle can be labeled as “Broad Spectrum.” Scientific data demonstrated that products that are “Broad Spectrum SPF 15 [or higher]” have been shown to reduce the risk of skin cancer and early skin aging when used with other sun protection measures, in addition to helping prevent sunburn.
What is the SPF value?
The SPF value indicates the level of sunburn protection provided by the sunscreen product, or protection from UVB radiation. All sunscreens go through a test that measures the amount of ultraviolet (UV) radiation exposure it takes to cause sunburn when a person is using the product in comparison to how much exposure it takes to cause a sunburn when the product isn’t used. The product is labeled with the SPF value that corresponds to the amount of sunburn protection the product provides. The higher the SPF value (up to 50), the better the sunburn protection. It is important to remember that the SPF value only represents the product’s ability to provide protection against UVB radiation.
Main Points of the New Rules:
- Broad Spectrum designation. Sunscreens that pass FDA’s broad spectrum test procedure, which measures a product’s ultraviolet A (UVA) protection relative to its ultraviolet B (UVB) protection, may be labeled as “Broad Spectrum SPF [value]” on the front label. For Broad Spectrum sunscreens, SPF values also indicate the amount or magnitude of overall protection. Broad Spectrum SPF products with SPF values higher than 15 provide greater protection and may claim additional uses, as described in the next bullet.
- Use claims. Only Broad Spectrum sunscreens with an SPF value of 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 between 2 and 14 can only claim to help prevent sunburn.
- “Waterproof,” “sweatproof” or “sunblock” claims. Manufacturers cannot label sunscreens as “waterproof” or “sweatproof,” or identify their products as “sunblocks,” because these claims overstate their effectiveness. Sunscreens also cannot claim to provide sun protection for more than 2 hours without reapplication or to provide protection immediately after application (for example– “instant protection”) without submitting data to support these claims and obtaining FDA approval.
- Water resistance claims. Water resistance claims on the front label must indicate whether the sunscreen remains effective for 40 minutes 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.
What do consumers most need to know when buying and using sunscreens?
Spending time in the sun increases a person’s risk of skin cancer and early skin aging.To reduce these risks,consumers should regularly use a Broad Spectrum sunscreen with an SPF value of 15 or higher in combination with other protective measures such as:
- Limiting time in the sun, especially between the hours of 10 AM and 2 PM when the sun’s rays are the strongest.
- Wearing clothing to cover skin exposed to the sun when possible.
- Using a water resistant sunscreen if swimming or sweating.
- Reapplying sunscreen, even if it is labeled as water resistant, at least every 2 hours. (Water resistant sunscreens should be reapplied more often after swimming or sweating, according to the directions on the label.)
Consumers should also be aware that no sunscreens are “waterproof” because all sunscreens eventually wash off. Sunscreens can only be labeled as “water resistant” if they are tested according to the required SPF test procedure. Sunscreens labeled “water resistant” sunscreens will also be required to state whether the sunscreen remains effective for 40 minutes or 80 minutes when swimming or sweating, and all sunscreens will be required to provide directions on when to reapply.