FDA Ruling on Sunscreens

The Food and Drug Administration (FDA) just released new guidelines for the labeling of sunscreen products. I thought I'd post a summary of the requirements of the ruling so you can be aware of what changes are coming to sunscreens. These products contain so many claims that this ruling should help clear up a lot of confusion consumers face when choosing a sunscreen product.

The new final rule includes the following requirements:

Broad Spectrum designation. Sunscreens that pass FDA's broad spectrum test procedure, which measures a product's UVA protection relative to its 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.

Use a sunscreen with a Sun Protection Factor (SPF) of 15 or higher. Sunscreens come in many forms, including ointments, creams, gels, lotions, wax sticks, and sprays.

If you do happen to get a sunburn, here are some tips from the Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health:

First Aid

- Take aspirin, acetaminophen, or ibuprofen to relieve pain, headache, and fever.

- Drink plenty of water to help replace fluid losses.

- Comfort burns with cool baths or the gentle application of cool wet cloths.

- Avoid further exposure until the burn has resolved.

- Use of a topical moisturizing cream, aloe, or 1% hydrocortisone cream may provide additional relief.

If blistering occurs:

- Lightly bandage or cover the area with gauze to prevent infection.

- Do not break blisters. (This slows healing and increases risk of infection.)

- When the blisters break and the skin peels, dried skin fragments may be removed and an antiseptic ointment or hydrocortisone cream may be applied.