Sunscreen Foundation Under Class I Recall

Microbial contamination prompted a recall affecting 9 lots of Suntegrity Impeccable Skin Sunscreen Foundation in multiple shades. According to recalling firm Suntegrity Skincare, a higher than acceptable microbiological mold count (Aspergillus sydowii) was discovered in several tubes from lot 115BU. 

“A topical product that is found to be contaminated with Aspergillus sydowii could potentially cause an allergic skin reaction and related symptoms,” Suntegrity Skincare announced in a June 11, 2024, statement. “It could also cause a primary fungal skin infection if used on open wounds or sunburned skin. If it is introduced into the eye, eye infections may occur.”

The recall primarily affects Suntegrity Impeccable Skin Sunscreen Foundation, buff shade (NDC 69949-152-01, UPC 854245006187), from lot 115BU (Exp. 6/25). The US Food and Drug Administration (FDA) designated the recall Class I on July 8, 2024. The classification warns use of the affected product could cause serious adverse health consequences or death.

“A primary skin infection due to Aspergillus species in an immunocompromised individual should be treated medically,” the firm stated.

Eight additional lots were included in the recall out of an abundance of caution despite having clear test results, Suntegrity Skincare said. The FDA designated them Class II, communicating use of products from the lots may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm:

• Suntegrity Impeccable Skin Sunscreen Foundation, ivory shade (NDC 69949-151-01, UPC 854245006170), from lot 107IV (Exp. 4/25);
• Suntegrity Impeccable Skin Sunscreen Foundation, nude shade (NDC 69949-156-01, UPC 854245006224), from lots 107NU (Exp. 6/25) and 109NU (Exp. 10/25);
• Suntegrity Impeccable Skin Sunscreen Foundation, buff shade (NDC 69949-152-01, 854245006187), from lot 117BU (Exp. 10/25);
• Suntegrity Impeccable Skin Sunscreen Foundation, sand shade (NDC 69949-153-01, UPC 854245006194), from lots 113SA (Exp. 6/25) and 114SA (Exp. 10/25);
• Suntegrity Impeccable Skin Sunscreen Foundation, bronze shade (NDC 69949-155-01, UPC 854245006217), from lot 106BR (Exp. 4/25); and
• Suntegrity Impeccable Skin Sunscreen Foundation, mocha shade (NDC 69949-157-01, UPC 854245006446), from lot 101MO (Exp. 5/25).

The recalled products were distributed online by Suntegrity Skincare, Las Vegas, Nevada, and via retail stores to customers in the United States, Canada, and elsewhere around the world.  

Suntegrity Impeccable Skin Sunscreen Foundation is labeled to help prevent sunburn. Suntegrity Skincare voluntarily initiated the recalls on May 24, 2024.