New Sunscreen Labeling Rules Issued by FDA

On June 14, 2011, the US Food and Drug Administration (FDA) issued its long-awaited rules for sunscreen labels, enabling consumers to more easily identify sunscreens that offer safe and effective protection from the sun’s cancer-causing ultraviolet (UV) radiation. The new regulations went into effect in December 2012 for larger manufacturers. Products grossing under $25,000 in sales now have until December 2013.

The guidelines include labeling requirements for protection against the sun’s ultraviolet A (UVA) rays. Sunscreens that meet FDA standards for both ultraviolet B (UVB) and UVA protection may be labeled “broad-spectrum,” a term that, until now, was frequently used but had no official meaning. Newly standardized methods for measuring UVA protection have made these improvements possible.

Broad-spectrum sunscreens with an SPF (sun protection factor, a measurement of protection against UVB rays) of 15 or higher are able to state, “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.” Sunscreen manufacturers have never before been able to make such a claim. 

FDA Sunscreen Labeling Guidelines at a Glance

  • Sunscreens may be labeled “broad-spectrum” if they provide protection against both UVA and UVB radiation according to FDA-sanctioned test methods.
  • Only broad-spectrum sunscreens with an SPF of 15 or higher may state that they help protect against skin cancer and early skin aging if used as directed with other sun protection measures.
  • Broad-spectrum sunscreens with SPFs of 2-14 must display a warning that the product has not been shown to help prevent skin cancer or early skin aging.
  • The terms “sunblock,” “sweatproof” and “waterproof” are no longer allowed on sunscreen labels.
  • Sunscreens may claim to be “water-resistant,” but must specify whether they protect the skin for 40 or 80 minutes of swimming or sweating, based on standard testing. Sunscreens that are not water-resistant must instruct consumers to use a water-resistant sunscreen if swimming or sweating.
  • A company cannot claim that its sunscreen products provide sun protection for more than two hours without submitting test results to prove this.
  • The FDA has proposed a regulation that would require sunscreen products with SPF values higher than 50 to be labeled “SPF 50+.” The FDA is seeking additional data before making a final ruling. Learn more about high-SPF sunscreens.
  • The FDA is currently reviewing the effectiveness of sunscreen wipes, powders, towelettes, as well as body washes and shampoo with sunscreen ingredients. No decisions have been made.
  • For sunscreen spray products, the agency has requested additional data to establish effectiveness and to determine whether they present a safety concern if inhaled unintentionally.* 

*The Skin Cancer Foundation recommends applying spray sunscreen in a well-ventilated room, or outdoors (keeping in mind that the wind may carry some sunscreen away). Keep your eyes and mouth closed when spraying sunscreen. When applying to the face, it’s best to spray the sunscreen on your hand and then apply to your face by hand.

 

Updated June 26, 2013