New Sunscreen Regulations: What You Need to Know
On June 14, 2011, The U.S. Food and Drug Administration announced new regulations for labeling sunscreen and other sun-blocking products. The familiar SPF categorization will still exist in an updated capacity, but will be joined by a new label, "Broad Spectrum." Depending on annual sales, companies will have until either December 17, 2012, or December 13, 2013, to comply with the FDA testing and update their labels accordingly.
If you sell sun-, skin-, or even lip-care products, you need to know what the new regulations mean and how they may affect your business. There is new terminology, new declarations that must be printed, others that are now banned, and several other changes that can affect the decoration and design of your personal care products.
What Are the New Regulations?
Starting December 12, sun block with the appropriate amount of UVA and UVB protection will be labeled as Broad Spectrum, indicating that it protects against premature aging and skin cancer as well as sunburn. Sunscreens that only protect against sunburn will not have the Broad Spectrum designation.
Sunscreen with SPF 2 to 14 will need to indicate on the packaging that the product has not been shown to help prevent skin cancer or aging. Labels will also need to indicate whether they are water-resistant and for how long, and display usage directions.
In addition, the FDA has proposed a rule that would limit SPF rankings to "50+" and is "currently reexamining the safety information available for active ingredients included in sunscreens marketed today." These proposals, while unlikely to have an impact by next year, may lead to further labeling and testing requirements down the line.
SPF? Broad Spectrum? UVA and UVB? What Does it All Mean?
Sun Protection Factor (SPF) has been the standard for sunscreen since the 1960s, but as scientists learn more about the way sun exposure works, it's become necessary to expand product testing and reporting. The addition of the Broad Spectrum classification will allow manufacturers to better detail what kinds of skin damage the lotion protects against.
"Broad Spectrum is the designation that a product reduces the risk of skin cancer and early skin aging," explained Megan Ludlow, marketing manager for SnugZ USA, based in Salt Lake City. "Broad Spectrum products still have a Sun Protection Factor. Any product that has an SPF below 15 would need to carry a warning stating that the product has not been shown to help prevent skin cancer or early skin aging. SPF 15 or higher will be permitted to claim that they help reduce the risk of skin cancer and premature skin aging."
Any product with the Broad Spectrum designation has an SPF 15 or higher rating, but not all products with SPF 15 and above will be labeled as Broad Spectrum. The difference is determined by how much protection a sunscreen provides against both ultraviolet A (UVA) and ultraviolet B (UVB) radiation, two of the leading causes of skin damage.
"UVA rays are known to cause skin cancer and early skin aging while UVB rays are known to cause sunburn," said Teresa Perdue, quality assurance director for Leashables by OraLabs, Parker, Colo. "On products labeled as SPF but not Broad Spectrum, the SPF value indicates the amount of protection against sunburn only."
It's therefore possible for a product to have an SPF 50 rating, but only provide protection against sunburn-causing UVB rays. "Sunscreens on the market today are a mix of those that have the sunscreen chemicals that provide both UVA/UVB protection and those that provide UVB protection only," Perdue said. "Companies will need to ensure the claims they are making on their sunscreen is backed by required testing."
How Will the New Rules Affect Your Business?
Many skincare products in our industry already abide by FDA requirements. "We will not need to change any of our formulas," Ludlow said of SnugZ USA's sunscreen and lip balm. "We will update our labels accordingly and provide testing for the UVA and UVB protection as well as the number of minutes that our sunscreen will be water-resistant."
The new labeling requirements should be the main focus of your attention. Once the regulations take effect, all packaging must reflect the new information in order to avoid fines. As a result, the space available for client's artwork may be affected.
"The new guidelines will definitely impact product labels and imprint areas," Perdue said. "If a sunscreen has the required standard testing to state water-resistant claims, it will now have to list the amount of time the product remains effective while swimming or sweating. That is additional lines of text for the front label. The back panels will be impacted as well because if a sunscreen is not water-resistant, it must include a direction instructing consumers to use a water-resistant sunscreen if swimming or sweating."
Beyond changes to labeling, distributor salespeople will want to make sure "they are using a company who complies with FDA guidelines, regularly tests their products, and ask for documentation to prove the tests were actually done," explained Ludlow.
Perdue echoed the need to work with known and trusted manufacturers with documentation proving FDA compliance. "There can be serious repercussions by the FDA, if a company makes a claim on a product they cannot substantiate. The FDA has increased its surveillance on cosmetics, food, drugs and dietary supplements to ensure the consumer is purchasing a product that can meet the claims being made by the company on that product," she said.