The U.S. Food and Drug Administration (FDA) is cracking the whip on makers of mousse sunscreen.
The federal watchdog group sent letters to five brands, including Supergoop!, Vacation Inc., Kalani Sunwear, K & Care Organics, and Fallien Cosmeceuticals (makers of TiZo sunscreen), stating that the frothy formulas are “misbranded.”
According to FDA rules, sunscreens can only be sold as oils, lotions, creams, gels, butters, pastes, ointments, sticks, sprays, or powders, not foams, mousses, or whips. If a company wants to sell a whipped sunscreen, it must submit a new drug application with sufficient data proving their safety and effectiveness.
“There are no FDA-approved applications in effect for your drug products,” the agency wrote in letters to the brands. This notification doesn’t necessarily mean the mousse sunscreens are unsafe.
Some of these products are packaged to resemble whipped cream. But “packaging drug products in containers that resemble food containers commonly used by adults and children can mislead consumers into mistaking the products for food, which is of particular concern as this increases the risk of accidental ingestion,” the FDA wrote.
The companies have 15 working days of receipt to let the FDA know about the specific steps it has taken to correct any violations. Failure to comply could mean that the products are pulled from the market. Stay tuned.
