FDA Gives Sunscreen Makers An Extension With Label Rules
May 16, 2012

FDA Gives Sunscreen Makers An Extension With Label Rules

Connie K. Ho for RedOrbit.com

As summer approaches and the weather gets warmer, many people will look to sunbathing as something to do to pass the time. If they do engage in sunbathing, they´ll have to take extra notice of sunscreen protection against harmful UV rays.

To help consumers in their search for the perfect product, the U.S. Food and Drug Administration (FDA) put in a few regulations regarding the marketing and labeling of products. However, recently, the agency announced that it would give sunscreen manufacturers another six months to comply.

According to Reuters, the extension was allowed to give companies extra time to avoid supply shortages. Last year, the FDA ordered sunscreen manufacturers to make a number of changes to their labels to better express to consumers how they should use the product. The agency decided to extend the deadline from June to December after major trade associations argued that their member companies were having difficulties making the changes; smaller companies have until December 2013 to comply.

"We're thinking proactively here... we don't want them to cease making sunscreens available this summer because they don't think they'll be able to meet the compliance date," said Shelly Burgess, a spokeswoman for the agency, in the article by Reuters.

Previous updates by the FDA have focused on rules regarding protection against ultraviolet B rays, but not ultraviolet A radiation. Ultraviolet A rays can cause skin cancer and early skin aging. Ultraviolet B radiation is known for causing sunburns.

With the new regulations, sunscreen makers would have to pass an exam by the FDA to prove that their products protect against UVA and UVB rays before being allowed to label their products as having “Broad Spectrum” protection. The products that pass the test can claim to reduce risk of skin cancer and early skin aging only if they have a sun protection factor (SPF) of 15 or higher. Sunscreen products that don´t pass the test or pass the exam but have SPF between 2 and 14 aren´t allowed to claim to prevent sunburns. Sunscreen manufactures also cannot claim to be “waterproof” or “sweat proof” under the new rules; they can only state that they are water or sweat resistant.  Lastly, sunscreens cannot be advertised as providing protection for more than two hours unless they submit data to the FDA that shows that their product demonstrates this trait.

Some people disagree with the extension given to sunscreen makers by the FDA.

“The FDA took a major step backwards today and as a result, more consumers will likely get burned this summer,” Senator Jack Reed (D-R.I.), who´s worked on having the FDA tighten regulations on sunscreen, told the Associated Press.

In the Associated Press article, Farah Ahmed of the industry´s Personal Care Products Council said that sunscreens aren´t undergoing reformulation. The FDA rules are based on revising the packaging of the sunscreen products. She believes that it takes time to change the labeling to fit extra information on what protection the sunscreen offers.

For consumers who are looking to buy sunscreen this summer, it´s important to look at the ingredient list. Dr. Joshua Zeichner, a dermatologist at Mount Sinai Medical Center in New York, explained to the Associated Press that sunscreens that have UVA protection include ingredients like zinc, titanium, avobenzone, or ecamsule. Zeichner also recommends using a sunscreen that has a SPF of 30 or higher. He believes it´s best to use about a shot-glass full of sunscreen and to remember to reapply the sunscreen often.