The U.S. gets tough on sunscreen claims

why is US sunscreen labelling rule so strict?


In the United States, regulators want consumers to know, that not applying the right sunscreen is harmful to health. You may have seen sunscreens from the US with the following Health Warning on the labels:

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.

Since 2012, the U.S. federal government agency, the Food and Drug Administration has required sunscreens with SPF values of 2 to 14, and are not broad spectrum to display the health warning on the product label. Broad spectrum is defined as a sunscreen that has proven to give both UV-A and -B protection. The labelling rule, also known as the Final Rule because it went through several years of review before it was passed in 2011, was not enforced until end 2012 to give sunscreen manufacturers time to update their labels to meet the new labelling rule.


Sunscreen, a skin protectant

Why is the FDA labelling rule on sunscreen more stringent than in Europe or Asia, where regulators do not require health warning labels to be printed on sunscreens with low SPF and UV-A protection?

The main reason is sunscreen is not categorised as cosmetics in the U.S., but as an over-the-counter drug. It is seen as a skin protectant like other non-prescriptive topical cream or medication used for skin treatment. This is why the U.S. is  strict on what goes into the sunscreen. FDA has not approved many chemical sun filters, that have already been available in the European market. Instead, it wants a history of data on toxicity and photo stability to ensure they are safe for use. But there hasn’t been a long history of data because these chemical sun filters are new. They only appeared in the market  from the 1990s to meet the growing demand for sun filters with good UV-A absorption.

By contrast, Europe is a hot-bed for research on chemical sun filters. European chemical-based sunscreens are arguably better than those in America because manufacturers could pick and choose from many more sun filters. However, the FDA’s reluctance to open the gates for more chemical sun filters into the U.S. encouraged the development of chemical-free sunscreens. Natural skincare companies flourished.  There are more chemical-free sunscreens available in the U.S. than Europe. The mineral compound, zinc oxide, is the active ingredient in most of these sunscreens, but it is an ingredient rarely found in European sunscreens.

Elsewhere, in Asia, there is a variety of BB creams and cosmetics, that have sun filters in their ingredients. Asian manufacturers are allowed to be more creative in their formulation than in America, where the rules are stricter. The good news is when sun filters are available in more products, more consumers are protected in the sun. The bad news is by combining sun filters with other ingredients, it may reduce the photo-stability of the sun filters, and increase the risk of free radicals and allergens. It is widely believed that there are more cases of skin allergies, and patients with skin sensitivity than before because daily skincare products are increasingly loaded with chemicals.

Related Story: How Safe are BB creams?

In the U.S., sunscreens that have SPF levels of 2 to 14, and do not meet the FDA standard of broad spectrum must carry a Health Warning on the label. On the other  hand, sunscreens with SPF values of 15 or more, and are broad spectrum would carry a recommendation that reads:

“If used as directed with other sun protection measures, this product reduces the risk of skin cancer and early skin aging, as well as helps prevent sunburn.”


Additionally, FDA also tightened the use of the term, “water resistant” on sunscreens. Claims of water resistant must be backed with evidence, and sunscreen manufacturers must specify the length of the protection in relation to the declared SPF levels on the sunscreens. Only two time periods  — 40 or 80 minutes — are permitted on the sunscreen label.

For e.g. a sunscreen that carries a label that reads, “water resistant for 40 minutes,” should be able to remain water resistant for a period of 40 minutes while sweating or swimming..  Words like “waterproof” and “sweat-proof” are no longer allowed on sunscreen labels. FDA also banned claims like “instant protection” or “sun protection for more than two hours without reapplication” from labels unless manufacturers could support these claims.

Questions you would likely ask when buying a good sunscreen are: What is the SPF?  Is this sunscreen broad spectrum? Is it water resistance, and for how long? If you are choosing a sunscreen from the US, the information will be clearly shown on the front of the label. Also, turn to the back to make sure it does not carry a health warning, but a recommendation.



FDA Sunscreen Label – Consumer Update, US’ Food and Drug Administration.

Does Europe have better sunscreens? Environmental Working Group.



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