Looking Fit 04/2004: Sunless 2004

With sunless continuing to gain momentum, it is critical that salons understand the sunless concept and issues that surround it. On July 1, 2003, the Food and Drug Administration (FDA) released information about dihydroxyacetone (DHA), the primary ingredient behind the explosive sunless craze. This statement came in response to many questions about the proper use of sunless booths and handheld airbrush tanning systems. Salons that offer sunless services should educate their employees about this important issue.

The Food, Drug, and Cosmetic Act (FD&C Act), Section 721 authorizes the regulation of color additives, including their uses and restrictions. Specifically, these regulations are found in Title 21, Code of Federal Regulations (21 CFR), beginning at Part 70. If a color additive is not permitted by regulation or is used in a way that does not comply with the specific regulation(s) authorizing its use, it is considered unsafe under the law. The FD&C Act prompted the FDA to clarify what it deemed proper “external use.”

The regulations list DHA as a color additive for use in adding color to the human body. However, its use in cosmetics—including sunless tanning products—is restricted to external application (21 CFR 73.2150). According to the CFR, “externally applied” cosmetics are those “applied only to external parts of the body and not to the lips or any body surface covered by mucous membrane” (21 CFR 70.3v).

In addition, no color additive may be used in cosmetics intended for use in the area of the eye unless the color additive is permitted specifically for such use. The CFR defines area of the eye as “the area enclosed within the circumference of the supraorbital ridge, including the eyebrow, the skin below the eyebrow, the eyelids and the eyelashes, and conjunctival sac of the eye, the eyeball, and the soft areolar tissue that lies within the perimeter of the infra-orbital ridge” (21 CFR 70.3s).

When using products containing DHA as a spray or mist, sunless airbrush technicians must avoid exposure to parts of the body for which DHA is not approved, including the area of the eyes, lips, or mucous membrane, or even inhalation. Because of this, the FDA suggests to consumers to ask the following questions when considering salons where DHA is applied by spraying or misting:

• Are consumers protected from exposure in the entire area of the eyes, in addition to the eyes themselves?
• Are consumers protected from exposure on the lips and all parts of the body covered by mucous membrane?
• Are consumers protected from internal exposure caused by inhaling or ingesting the product?

If the answer to any of these questions is no, the FDA says that the consumer is not protected from the use of sunless products. In this case, the FDA suggests that the consumer request measures to protect their eyes and mucous membranes and prevent inhalation.

Staff should take extra care in informing clients to avoid breathing the sunless product during the application process. Consumers also should try to avoid direct application of the product into the eye area as described earlier. They should use a lip balm or other barrier product on the lips and in the nostrils to avoid contact with the mucous membrane. Barrier creams and specially designed air-filtration devices are available through sunless product distributors and manufacturers.

The FDA’s cautious opinion on DHA most likely stems from information found in the products’ dated Material Safety Data Sheet (MSDS). DHA was first approved for cosmetic use in 1973. From its original use as a topical substance, DHA was listed with three risk numbers—R36, irritating to eyes; R37, irritating to the respiratory system; and R38, irritating to the skin.

The risk numbers are based on pure forms of DHA with no other additives considered, i.e., water. To put this into perspective, the purist form of many cosmetic ingredients typically fall under the same risk numbers.

To best take advantage of the bronzing effects of sunless products in its newest form, prudent salon owners and staff should revert to common sense when it comes to offering sunless in a spray or mist form. Have clients avoid getting this and other tanning products directly into their eyes. Assure proper ventilation for staff and clients in the sunless application area of the facility. And avoid contact with the mucous membrane of the mouth and nose by using a barrier product in the nostrils and on the lips.