Sunscreen Foundations Recalled Nationwide Due to Risk of Fungal Infection

The U.S. Food and Drug Administration (FDA) in White Oak, Md., on June 5, 2023. Madalina Vasiliu/The Epoch Times

Skincare company Suntegrity is recalling some of its Sunscreen Foundations after testing showed a “higher than acceptable” microbiological mold count, according to a notice posted on the US Food and Drug Administration’s (FDA) website on June 11.

The Las Vegas-based skincare company is voluntarily recalling nine lots of its “Impeccable Skin Sunscreen Foundation” in multiple shades after a recent test discovered the higher amounts of Aspergillus Sydowii in some tubes, which it said developed “post-release and over time.”

Suntegrity Impeccable Skin Sunscreen Foundation helps prevent sunburn, according to the label, and is packaged in 2-ounce orange tubes. Customers can find the product lot number on the back of the tube, at the top where the tube is sealed.

The items subject to the recall are:

• Lot No. 107IV in the shade “Ivory,” (Exp 04/25)
• Lot No. 107NU in the shade “Nude,” (Exp 06/25)
• Lot No. 109NU in the shade “Nude,” (Exp 10/25)
• Lot No. 117BU in the shade “Buff,” (Exp 10/25)
• Lot No. 113SA in the shade “Sand,” (Exp 06/25)
• Lot No. 114sA in the shade “Sand,” (Exp 10/25)
• Lot No. 106BR in the shade “Bronze,” (Exp 04/25)
• Lot NO. 101MO in the shade “Mocha,” (Exp 05/25)

The products were distributed online by the company and at retail stores nationwide, according to the notice.

Aspergillus Sydowii is a pathogenic fungus commonly found in soil.

Risks of Aspergillus Sydowii Contamination

“A topical product that is found to be contaminated with Aspergillus Sydowii could potentially cause an allergic skin reaction and related symptoms,” the notice on the FDA’s website said. “It could also cause a primary fungal skin infection if used on open wounds or sunburned skin.”

The notice also stated that eye infections may occur if contaminated products are introduced into the eye.

“A primary skin infection due to Aspergillus species in an immunocompromised individual should be treated medically,” the notice on the FDA website said.

In a separate notice, Suntegrity said it was alerted to the potential contamination after a customer detected a “strong odor” in a tube of the product.

“We recently tested tubes from various batches of Impeccable Skin (with and without an off-odor) and the issue seems to be present only when there is a strong odor,” the company said.

“If you have been using Impeccable Skin and the product did not have an unusual odor, the product is not likely to have had an issue at the time of use because all of the batches passed microbiological testing when they were initially released for sale,” the company noted.

Customers Can Exchange, Refund Recalled Items

Suntegrity

Suntegrity said the recall was being conducted “out of an abundance of caution” while the company continues to investigate the situation, “even though all original and recent test results received have come back clear.”

No adverse events have been reported in relation to the recalled items, according to the notice. However, all distributors, retailers, and consumers are being asked to immediately stop using or selling the products.

Suntegrity said it has also notified its distributors, retailers, and website customers by email and is arranging for the disposal of all recalled products.

Customers who bought the recalled items directly from the SuntegritySkincare.com website or via Amazon from Suntegrity can email [email protected] with their order number, product lot number, and name to receive a refund or store credit or to replace the item with another Suntegrity Face SPF product.

Consumers who purchased them from retailers across the U.S. can also visit the store to receive store credit.

In that case, customers will need to provide proof of disposal of the tube with a photo of the back (showing the lot number) to confirm receipt and processing of these recall instructions, according to the notice.