The skin health mantra for “wearing sunscreen” still resonates loudly and clearly, but a new warning letter from the FDA puts some formulations under fire.
According to Cincinnati, Ohio cosmetics Kelly Dovos said on August 6 that Supergoop for an unapproved dose format! , Vacation Inc., Kalani Sunwear, Fallien Cosmeceuticals (Tizo Brand) and K&Care Organics have issued warning letters.
“The FDA noted that, according to the commercially available monograph M020, sunscreen in doses other than oils, lotions, creams, gels, butter, pastes, ointments, sticks, sprays and powders could only be sold legally with approved new drug applications.
“The FDA may be concerned that mousse or foam may not provide proper coverage, which is important for effective sun protection,” she says. “Brands should have done appropriate testing to make label claims, but if the dosage form is not listed in the rules, it is not sufficient for the FDA. New dosage forms that are not listed will require new drug application.”
The FDA also said that the product could pose a risk to consumers as it is packaged because it resembles a whipped cream container, which could pose a risk to consumers, which could increase the risk that someone might mistakenly consume it for food.
It is specifically referred to by characters. “To date, no secretary has issued a final order of less than 505g(b) or 505g(c).
“This could mean that vacation whipped sunscreens could be pulled out of the market,” Dobos says. “The warning letter states: “If this issue is not properly addressed, there could be legal action, including unrestricted seizures and injunctions.”
