The US Food and Drugs Administration (FDA) has issued a warning to popular sunscreen brands over their mousse products.
The regulator has sent five warning letters about this type of sun care format, which is also called ‘whipped’ due to its foam-style texture.
In a post on X (formerly known as Twitter), the FDA said: “Beware of sunscreen products in mousse form because they might not be effective.
“The FDA issued five warning letters to companies marketing sunscreen products in mousse form.”
Supergoop! was sent a warning letter about its PLAY SPF Body Mousse, and Vacation was issued a similar notice concerning two of its products: Classic Whip Broad Spectrum SPF 30 Sunscreen Mousse and Classic Whip Glow Broad Spectrum SPF 30 Shimmer Sunscreen Mousse.
Sunscreen formats approved in the US by the FDA include oil, lotion, cream, gel, butter, paste, ointment, stick, spray, and powder.
However, current rules do not cover sunscreen “in a mousse dosage form”, according to the letters.
Vacation’s use of metal canisters that look like those used to dispense edible whipped cream have also been deemed “misleading” to consumers and the FDA said it could pose a risk of accidental ingestion.
The FDA also issued warning letters to K & Care Organics, which runs the Botao brand, Kalani Sunwear and Fallene Cosmeceutical, which owns the brand TiZo, over their mousse sunscreen products.
Sunscreens are categorised as over-the-counter (OTC) drugs by the FDA, meaning there are stricter requirements, including around marketing and labelling, than in other countries where they are considered cosmetic products.
Supergoop! said in a statement: "At Supergoop! we remain committed to innovation in sun care and the highest standards of product efficacy and safety.
"The recent communication from the FDA regarding our PLAY SPF 50 Body Mousse is focused on product labeling and has nothing to do with its safety, effectiveness, or formula.
"We are working closely with the FDA to resolve this matter as we continue to uphold the high standards our consumers expect from us."
Kalani Sunwear said in a statement provided to Cosmetics Business: “Kalani Sunwear can confirm that the recent FDA warning letter concerns only the fact that, under US regulations, SPF products are classified as drugs and therefore require registration before being marketed in the United States.
“The letter does not state that mousse-format sunscreens are less effective or unsafe, nor does it question the quality or performance of our formulation.
“Our Sun Mousse SPF 50 is developed and manufactured in Sweden to the highest European standards and uses the most advanced UV filters currently available — filters not yet approved for use in the US, where the last new UV filter approval occurred in 1999.
“These provide proven protection against both UVA and UVB radiation and meet all stringent EU safety and efficacy requirements.”
Cosmetics Business has contacted, Vacation, K & Care Organics and Fallien Cosmeceuticals for comment.
The companies must respond to the FDA within 15 days, laying out the steps it has taken to correct the violations and prevent recurrence, or provide information on why it believes it is not in violation.