Suntegrity Skincare, of Las Vegas, Nevada, has voluntarily recalled 9 lots of its Suntegrity Impeccable Skin Sunscreen Foundation in multiple shades because the microbiological mold count (of the species Aspergillus Sydowii) in some tubes was found to be “higher than acceptable,” reports the FDA.
Officials say the higher mold count in those tubes came from a single lot (Lot 115BU) and were found to have formed after the release of the product and over time, according to a recent test. However, Suntegrity Skincare decided to recall additional lots as a precautionary measure, despite the fact that all original and recent tests have returned clear: 107IV, 107NU, 109NU, 117BU, 113SA, 114SA, 106BR, and 101MO.
According to the FDA, those who use topical products contaminated with Aspergillus Sydowii may experience an allergic skin reaction. In open wounds or on skin that is sunburned, use of the product may lead to a primary fungal skin infection. Similarly, users are at risk of eye infections if the affected product makes contact with the eye. Immunocompromised individuals who develop a primary skin infection involving the Aspergillus species should seek medical attention.
To date of the FDA announcement, released June 11, 2024, Suntegrity Skincare has not received any reports of related adverse events.
Indicated for sunburn prevention, Suntegrity Impeccable Skin Sunscreen Foundation is packaged in 2-ounce orange tubes bearing the product lot number on the backside and along the top near the seal. Affected lots, which can be referenced in the chart included in the FDA communication, were distributed by the company online and through retail stores across the country.
Since the announcement, Suntegrity’s distributors, retail partners, and website customers have been notified via email, and the company has also begun arranging to have all recalled products safely disposed. Anyone who happens to be in possession of any of the affected products is urged to immediately cease all use.
Customers who either purchased the product via SuntegritySkincare.com or through Suntegrity’s Amazon store should email their order number, product lot number, and their name to ImpeccableSkinRecall@SuntegritySkincare.com in order to verify their purchase. Upon verification, customers seeking refunds, store credit, or an exchange (in the form of another Suntegrity Face SPF product) are asked to show proof that they’ve disposed of the tube, with a photo showing the back of the package, where the lot number is found.
Affected products that were purchased from a retailer may be exchanged (for a 5-in-1 Tinted Sunscreen and a free gift) by emailing Suntegrity directly at ImpeccableSkinRecall@SuntegritySkincare.com. Those seeking store credit should reach out to the retail point of purchase. Customers should note that photo proof of disposal (and lot number) are required to process the credit.
Recall-related questions may be directed to Suntegrity Skincare via email at ImpeccableSkinRecall@SuntegritySkincare.com, Emails will be monitored, and responded to as soon as possible, on Monday through Friday, from 9:00 a.m. to 5:00 p.m. Pacific Time. Those experiencing any health problems believed to be connected to the over-the-counter product should consult their physician or healthcare provider.
As the FDA continues to monitor this recall, any adverse reactions or quality issues should be reported to the agency’s MedWatch Adverse Event Reporting program.
Our compassionate attorneys at TruLaw are personally invested in connecting you with the legal support and representation you need after a distressing medical event. If you or a loved one has suffered an adverse health outcome that can be traced to a mold contamination in a topical drug, you deserve maximum compensation. We are here to help you build a case for your desired outcome and hold negligent parties responsible. Contact us online or take our free Instant Case Evaluation ℠ to learn more.