Online Exclusive: FDA Issues New Sunscreen Regulations
The agency issues final rule for labeling and effectiveness testing for OTC sunscreen products sold in US.
Written by Holly Jensky

On June 14, 2011, the U.S. Food and Drug Administration (FDA) issued a final rule, establishing the labeling and effectiveness testing for over-the-counter (OTC) sunscreen drug products*—sunscreens, sunscreen cosmetics, skin moisturizers and the like—with ultraviolet B (UVB) and ultraviolet A (UVA) protection. The requirements in the final rule will help ensure sunscreen products are appropriately labeled and tested for both UVA and UVB protection, as well as ensure their proper use. This is the first time the FDA has addressed UVA protection in relation to sunscreen products. The FDA is requiring that all sunscreen products tell consumers how they can further protect themselves against the sun’s harmful rays.
 

Preparation is key for making a smooth transition to the new sunscreen labeling requirements.

The final rule will take effect June 18, 2012. Since the release of the final rule, amending the “Final Monograph of 1999,” health and beauty companies have taken a deeper look into the new regulation and what it will mean for their products, packaging and label designs, as well as overall brand identity.

The FDA is requiring that sunscreen labeling inform consumers as to how well the product protects against UVA light—electromagnetic radiation, given off by the sun, that causes tanning of the skin. Regulations concerning UVA light were delayed until reliable testing methodologies could be codified and finalized. Recently, the FDA determined that sufficient data are now available to institute a standard broad spectrum test procedure to measure UVA protection in relation to the amount of UVB protection (UVB light or electromagnetic radiation given off by the sun that is primarily responsible for sunburn).

Under the final rule, sunscreen products that pass the broad spectrum test are to be labeled as “Broad Spectrum,” meaning the product protects against both UVA and UVB rays. The new Broad Spectrum designation will give consumers a better understanding of which sunscreen products offer the greatest protection of UVA and UVB radiation, which will help them make better-informed decisions about protecting themselves and their families against the harmful effects of the sun. In order to pass the test, the amount of the UVA protection must increase as the sun protection factor (SPF) value increases.

Broad Spectrum sunscreen products with an SPF value of 15 or higher, not only help protect against sunburn, but also help protect against early skin aging and skin cancer, when used as directed and with other sun protection measures. These products are required to include the statement “Broad Spectrum SPF,” followed by the numerical SPF value, on the primary display label. The statement must appear as continuous text, with no intervening text or graphics. The FDA is requiring that the entire text be the same font style, size and color on the same background color. In addition, the products may include the following indication statement, on the Drug Facts panel under the “Uses” section, to inform consumers that using the product, “as directed with other sun protection measures decreases the risk of skin cancer and early skin aging caused by the sun.”

Conversely, sunscreen products that do not pass the broad spectrum test, or those that are Broad Spectrum approved with a SPF value less than 15, are required to clearly state the SPF rating on the primary display label, and include the following warning statement on the Drug Facts panel, “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.”

In addition to the Broad Spectrum SPF rating, the FDA now requires sunscreen product labels to include information advising consumers that using a sunscreen product is just one way they can protect themselves against overexposure to UVA and UVB rays. Limiting time in the sun and wearing protective clothing, as part of a comprehensive sun protection regimen, are other recommendations that will be prominently displayed on labels. Using sunscreens liberally and reapplying frequently will also be advised.

Until now, an OTC sunscreen product was allowed to contain the statement “water- resistant” on its primary label if the product was shown to retain the labeled SPF value after 40 minutes of water immersion, or “very water-resistant” if it was shown to retain the labeled SPF value after 80 minutes of water immersion. The product, if water-resistant or very water-resistant, was additionally required to indicate whether it was formulated to be water-resistant for 40 or 80 minutes, and include timing and directions for reapplication under both the “Uses” and “Directions” sections on the Drug Facts panel.

Under the new final rule, any OTC sunscreen product that is water-resistant is now required to contain the statement “water-resistant (40 minutes)” or “water-resistant (80 minutes)” on its primary display label. The products are still required to include timing and directions for reapplication on the Drug Facts panel, but only under the “Directions” section.

No manufacturer can label a sunscreen product as “waterproof” or “sweatproof,” as these claims exaggerate product effectiveness, or identify their products as “sunblocks.” Additionally, manufacturers cannot claim a sunscreen product will provide sun protection for longer than 2 hours without reapplication, or will provide “instant protection” without submitting supporting data to these claims and obtaining FDA approval.

Sunscreens that are not water-resistant must instruct consumers to use a water- resistant sunscreen when swimming or sweating.

According to Holly Young, president and regulatory graphic specialist for H+Y Regulatory Graphics Consultants—a firm of regulatory compliance experts for U.S. and global beauty industry—many companies within the beauty and personal care industry have been including SPF/sunscreen in their product formulations for lipsticks, lip balms, facial cosmetics, skin moisturizers, etc., as an added benefit.

“The final rule for labeling and testing requirements for OTC sunscreen products has many companies concerned, regarding the potential technicalities it could pose, and how the regulation will affect product packaging,” Young said. “Although there are solutions available for all sunscreen/SPF packaging types, there’s a possibility that some companies will start to remove sunscreen from their products. If sunscreen is taken out, a company would most likely face having to develop a new product formula.”

Young notes, common concerns expressed by health and beauty companies regarding the final rule include:
• How will I label products packaged in small containers, tubes, etc.?
• How will my packaging look, and will it still communicate the product’s brand promise?
• What will the public’s perception be, with the additional labeling?
• What are the long-term ramifications of the final rule?
• How will the final rule affect the packaging graphics, costs, etc.?
• Does my product now require a carton or an extended text label?

Maintaining Brand Identity
Health and beauty companies have only a matter of seconds to capture consumers’ attention at the shelf. Labeling and packaging are two of the most influential tools for brand owners to communicate with consumers and influence their purchasing decisions.

“It’s certain that the federal government is looking out for the health and safety of consumers,” Young said. “It’s imperative that companies start assessing their products, product messaging and overall brand identity, so they can maintain a successful brand image while implementing the new regulation.”

Preparation is key to ensuring a smooth and successful transition to the new sunscreen labeling requirements. Young strongly advises that a company work together with its art department to pull all existing sunscreen/SPF product packaging and labels, and identify the possible label complications that could arise from incorporating the new regulations onto the packaging.

As noted, the final rule will significantly change the primary display label of a package. The remainder of the package will need to contain the “Drug Facts” panel, which must meet multiple requisites regarding the size of type, spacing, text and graphics.

“It’s crucial that companies maintain the brand identity of their product while meeting the regulatory compliance for product packaging graphics,” Young added. “All of the changes and additions that are part of the final rule are quite significant for the labeling of all sunscreen products. These changes and additions, while they are challenging, are designed to help consumers make better choices for their health and well-being.”

“Conversely, the health and well-being of your brand depends on holding on to your brand identity while incorporating these new regulations, and hopefully coming out stronger in consumer response to your brand,” Young added.

The FDA is allowing companies one year to implement the new labeling requirements. Products with annual sales of less than $25,000 will need to comply with the final rule by June 17, 2013. For items that are currently on the shelf, the FDA provides enough time for people to sell the product they already have labeled. The objective is to avoid financial hardship because of a labeling change, allowing existing label inventories to be used up before the new regulations become mandatory.

While the final ruling does pose some packaging and labeling challenges, there are resources available that can provide solutions. One such resource is extended text labeling. These labels enable a health and beauty company to retain the same label footprint as before, versus having to expand the label size to meet regulatory requirements. Extended text labels can offer the space brand owners need for multiple languages, consumer education, health and safety warnings, and cross-branding opportunities, while reducing the need for additional packaging.

“Extended text labels communicate more information without impeding a brand’s identity and positioning,” said Paulette Gramse, MultiVision product development manager for WS Packaging Group. “Companies may want to consider extended text labels when redesigning their primary labels to comply with the final ruling.”