Do The New FDA Regulations On Sunscreens Impact Product buys?

Technological advancements fueled by new requirements make a compelling reason for new innovations and guidelines in skincare. But sometimes it is the consumer who gets lost in this wide plethora of ever changing options.  Across the world dermatologists and skin care experts have emphasized the importance of sunscreens in preventing premature aging and reducing chances of skin cancer. It has emerged as one of the ‘must have’ skin care product.

The FDA recognizes the need to help consumers in understanding sunscreens better and has come up with new directives for sunscreen manufacturers to sell their products. Here is a sharp look at what these regulations are to help you make your sunscreen buys easier.

The test change: FDA has recognized that all sunscreens have to go through a more intensive test to be called a broad spectrum protectant. This test will ensure that the sunscreen protects not only from the UVB rays but also UVA rays. Dr. Ronald L. Moy, president of The American Academy of Dermatology Association states, “For the first time, 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,”. Only when a sunscreen has passed this test and offers a 15 SPF or more sun protection will it be allowed to make claims of preventing premature aging and reducing chances of skin cancer. Sunscreens that do not offer broad spectrum protection have to issue a warning on their label that warns the user of the consequences of sun damage. The warning will read as, “Skin Cancer/Skin Aging Alert:  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 skin cancer or early skin aging.”

This change in testing protocol makes me as a consumer feel comfortable with my buys. I can now decide better on what sunscreen product will help, both now and long-term.

Goodbye to labels such as ‘waterproof’, ‘sweat proof’ and ‘sun block’: The FDA has asserted that no sunscreen shall have the words ‘waterproof’, ‘sweat proof’ and ‘sun block’ mentioned on its label. Such claims are misleading as they overstate the products effectiveness. Products can only be labeled such once they have undergone standard FDA tests. Along with this the label has to state the duration of time for which the sunscreen remains effective while swimming, indulging in water related activities or sweating. Non water resistant sunscreens have to carry a warning on their label urging the consumer to use a water resistant sunscreen when swimming or sweating.

Great! these labels are going to help me buy better when on my next mountain climbing vacation.

Cap at SPF 50+: The FDA proposes to cap the SPF value of sunscreens at SPF 50+. This proposed cap has been reached due to the absence of sufficient data to prove that sunscreens above this SPF value provide greater protection. Studies reveal that between an SPF value of 50 and 75 the difference in sun protection is only 0.6%.

I had this feeling for a long time that companies were trying to claim ‘better sun protection’ by increasing the SPF levels to 80+/100+ without actual differences in protection. The FDA’s research and ruling has made my gut feeling come true!

Dosage forms in the sunscreen monograph: The FDA sunscreen enforcement policy allows certain dosage forms of OTC sunscreen products. FDA allowable delivery systems for sunscreens are lotions, gels, body butters and creams, pastes, ointments, sticks and sprays. The dosage products that don’t fall in this monograph are wipes, towelettes, body washes, shampoos and powders.

I used to always wonder on how a shampoo could sun protect! Now, I have science backing my intuition.

This FDA Ruling will come into effect for most manufactures from June 2012.  For companies whose annual sales is less than US$25,000 this will take effect from June 2013. This Final rule is an effort to “modernize…product information” for sunscreens according to Dr. Jane Woodcock, Director FDA Center of Drug Evaluation.

Will the  FDA guidelines make your sunscreen buys easier/difficult? Write in and share with us.


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