Sunscreen Recalled Nationwide as FDA Sets Risk Level

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A recall has been initiated nationwide for a sunscreen product, with the U.S. Food and Drug Administration (FDA) setting the risk level at Class III.

Why It Matters

Per the FDA, Class III recalls are the "the least serious of the three types of FDA recalls. Class III recalls apply to minor product defects or errors that are unlikely to cause harm to someone's health."

The FDA's other recall classes include Class II, which are applied in "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote;" and a Class I recall, the most serious. This is applicable in "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death."

What To Know

A release from the FDA said that 4,834 tins of "BADGER 50, ADVENTURE SPORT MINERAL SUNSCREEN WITH CLEAR ZINC," from The W.S. Badger Company, Inc., in New Hampshire were recalled due to a missing label.

Newsweek has contacted the W.S. Badger company for comment via email.

"The finished product potentially missing the labeling with the drug facts panel, bar code and directions for use," the FDA said.

The voluntary recall by the company was initiated on January 17, the release said, with the center classification date being January 29.

In June last year, a separate sunscreen recall prompted a nationwide warning after certain products were found to contain mold.

The FDA said at the time that Suntegrity Skincare's Impeccable Skin Sunscreen Foundation developed "a higher than acceptable microbiological mold count" over time.

Allergic skin reactions were one potential effect.

"It could also cause a primary fungal skin infection if used on open wounds or sunburned skin," read the FDA's release at the time. "If it is introduced into the eye, eye infections may occur. A primary skin infection due to aspergillus species in an immunocompromised individual should be treated medically."

Separately, a facial moisture recall was initiated due to a deviation from Current Good Manufacturing Practice regulations—which are essential to ensure the safety and efficacy of pharmaceutical products—Newsweek reported earlier this month, with the FDA giving the recall its second-highest risk classification.