FDA Ups the Ante on Sunscreen Labeling Requirements

Rockville, MD—The labeling and marketing of sunscreens just got a whole lot harder. The U.S. Food and Drug Administration (FDA) has issued new rules that introduce revised parameters for what sunscreen manufacturers can say about their products.

Effective as early as June 2012, products that have an SPF of less than 15 and those that don’t pass broad-spectrum tests (which examine whether it protects against both UVA and UVB rays) must alert shoppers on their labels that they cannot prevent skin cancer or aging. Only sunscreens that pass such tests and have higher SPFs can make such claims.

And, if companies want to say their products are waterproof, sweatproof or are sunblocks, they must submit additional data to FDA for review. Also, products can no longer claim to have SPFs of 50+ because FDA doesn’t feel current data support the benefit of extremely high SPFs.

“FDA has evaluated the data and developed testing and labeling requirements for sunscreen products, so that manufacturers can modernize their product information and consumers can be well-informed on which products offer the greatest benefit,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research in an FDA press release. “These changes to sunscreen labels are an important part of helping consumers have the information they need so they can choose the right sun protection for themselves and their families.”

The new rule will affect products with $25,000+ sales beginning June 18, 2012, and June 2013 for other sunscreens. The guidelines are available at www.gpo.gov/fdsys/pkg/FR-2011-06-17/pdf/2011-14766.pdf.

Published in WholeFoods Magazine, August 2011