National Council Praises New FDA Sunscreen Rules
Release Date: 
Tue, 06/14/2011


The National Council on Skin Cancer Prevention Praises New FDA Sunscreen Rules

The National Council on Skin Cancer Prevention applauds the U.S. Food and Drug Administration’s (FDA) for issuing new sunscreen regulations. The rules are designed to give consumers better information about which sunscreen products offer the most protection from both ultraviolet A (UVA) and ultraviolet B (UVB) exposure, which contribute to sunburn, skin cancer and premature skin aging

Sun protection is an important public health issue, and sunscreen is an integral part of a comprehensive sun protection regimen that also includes seeking shade, wearing long-sleeved pants and shirts, hats and sunglasses.

“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 Sandra I. Read MD, FAAD, co-chair of the National Council.

Broad-spectrum protection means a sunscreen protects the skin from ultraviolet A (UVA) and ultraviolet B (UVB) rays, both of which can cause skin cancer, including basal cell carcinoma, squamous cell carcinoma and melanoma, the deadliest form of skin cancer. UVB rays cause sunburn; UVA rays penetrate deeper, causing premature aging. Both rays damage the immune system. The amount of protection a sunscreen provides against UVB rays is indicated through its SPF (Sun Protection Factor) number, but until now, the FDA has not required a consistent standard for measuring a sunscreen’s UVA protection.

The new FDA regulations will allow sunscreen products that pass the FDA’s test for protection against both UVA and UVB rays to be labeled as “Broad Spectrum.” To pass the test, a sunscreen must provide a certain percentage of protection against UVA rays compared to UVB rays. The new FDA regulations also require that sunscreen product labels include statements that educate the public about the dangers of sun exposure and how to protect themselves.

“The FDA clearly gave careful consideration to the comments and weighed the scientific evidence to prepare these regulations,” said dermatologist Henry W. Lim, MD, FAAD, past National Council co-chair. “The FDA has now established testing guidelines that will ensure consumers who choose a broad-spectrum protection sunscreen with SPF 15 or higher will receive excellent protection from UVA and UVB rays.”

The FDA is also proposing some additional changes that could affect sunscreens in the future. One proposal is to limit the maximum SPF on labels to “50+” because there isn’t enough information to prove that sunscreens with SPFs higher than 50 provide any greater protection for users.

Every year, more than 3.5 million new cases of skin cancer affecting more than 2 million people will be diagnosed in the United States. Exposure to ultraviolet (UV) radiation is the most preventable cause of skin cancer.

Here are the main points in the FDA’s new sunscreen rules:

  • Sunscreens may be labeled “broad-spectrum” if they provide protection against ultraviolet A (UVA) and ultraviolet B (UVB) radiation.
  • Only broad-spectrum sunscreens with a Sun Protection Factor (SPF) of 15 or higher can state that they protect again skin cancer if used as directed with other sun protection measures.
  • Sunscreens with an SPF of 2-14 will be required to have a warning stating that the product has not been shown to help prevent skin cancer or early skin aging.
  • The terms “sunblock”, “sweatproof” and “waterproof” are no longer allowed on sunscreen labels.
  • A sunscreen may claim to be “water resistant”; however, the product must specify if it offers 40 minutes or 80 minutes of protection 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.
  • Sunscreens cannot claim to provide sun protection for more than two hours without reapplication.
  • Sunscreen manufacturers will have one year to comply with the FDA ruling; smaller companies will have two years.
  • The ingredients in sunscreens marketed today have been used for many years and FDA does not have any reason to believe these products are not safe for consumer use.
  • The FDA reiterated that sunscreen alone is not enough, and should be used in conjunction with a complete sun protection regimen, including seeking shade, wearing long-sleeved pants and shirts, hats and sunglasses.

 Click here to read the FDA Final Sunscreen Monograph.