Sunscreen Rules – New FDA Sunscreen Rules

Sunscreen New FDA RulesThe FDA will be requiring sunscreen manufacturers to rate their products’ level of protection against UVA rays with one to four stars to let consumers know just complete their protection will be.  When selecting a sunscreen, these new FDA rules will give consumers the added assurance that the sunscreen they choose will provide the exact benefits which the product claims to provide.

The U.S. Food and Drug Administration (FDA) announced on May 11 that it is giving sunscreen manufacturers an additional six months to make the required labelling changes that will help users be more discerning when choosing a sunscreen.

According to FDA new sunscreen regulations, sunscreen manufacturers need to revise their sunscreen labels to allow consumers distinguish brands that could be labelled as “broad-spectrum ”, meaning they protect against both ultraviolet A and ultraviolet B rays. UVA and UVB rays contribute to skin cancer and early skin aging.

According to the new guidelines for sunscreen, sunscreens that pass the FDA’s broad-spectrum test, to see if they protect against both ultraviolet A and ultraviolet B rays, may be labelled as “Broad-Spectrum SPF” on the front label.

Only broad-spectrum sunscreens with an SPF value of 15 or higher can claim to reduce skin-cancer risk and early skin aging if used as directed with other protective measures. Other sunscreens, including those with an SPF value between 2 and 14, can claim only to help prevent sunburn.

Sunscreen rules from FDA also say brands cannot claim to be a sunblock, sweatproof or waterproof on their labels, to alert users that they must reapply the products every few hours.  Sunscreens cannot claim to provide sun protection for more than two hours without reapplication or to provide immediate protection without having submitted data to obtain FDA approval.

The new sunscreen guidelines also say that ”Water-resistance” labelling must indicate whether the sunscreen is effective for 40 minutes or 80 minutes while swimming or sweating. Other sunscreens must include a recommendation advising consumers to use water-resistant sunscreen if swimming or sweating.

Sunscreen products do not need to be reformulated to meet the new guidelines.  All sunscreen products must include standard drug-facts information on the back or side.

Major manufacturers have till December 2012 to make the necessary changes. Smaller companies have an even more generous deadline of December 2013. The FDA’s rationale of allowing the extension is to prevent sunscreen shortages.

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