Suntegrity Skincare Issues Voluntary Recall of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) Due to Microbial Contamination

Summary

---

Company Announcement

FOR IMMEDIATE RELEASE - Jun 11, 2024 – Las Vegas, Nevada. On May 24, 2024, Suntegrity Skincare initiated a voluntarily recall of nine lots of Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) based on its discovery of a higher than acceptable microbiological mold count (Species: Aspergillus Sydowii) in some tubes of Lot 115BU that developed post-release and over time in a recent test. Out of an abundance of caution while investigating the situation, the company has decided to voluntarily recall these additional lots: 107IV, 107NU, 109NU, 117BU, 113SA, 114SA, 106BR, and 101MO even though all original and recent test results received have come back clear.

A topical product that is found to be contaminated with Aspergillus Sydowii could potentially cause an allergic skin reaction and related symptoms. 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. A primary skin infection due to Aspergillus species in an immunocompromised individual should be treated medically. No adverse event reports had been received at the time of the recall.

Suntegrity Impeccable Skin Sunscreen Foundation is labelled to help prevent sunburn and is packaged in 2 oz orange tubes. The product Lot number can be found on the back side of the tube at the top where the tube is sealed. See table below for a list of all lots and expiration dates. Product was distributed online by the company and nationwide via retail stores.

Suntegrity has notified its distributors, retailers and website customers by email and is arranging for disposal of all recalled products. All Consumers/distributors/retailers that have subject product (See Lot Numbers above) have been advised to immediately stop use and:

• If you have purchased this product directly from the SuntegritySkincare.com website or via Amazon from Suntegrity: email ImpeccableSkinRecall@SuntegritySkincare.com with your order number, product lot number, and name so your purchase can be verified. After confirmation, you will need to provide proof of disposal of the tube with a photo of the back (showing the lot number) so that you may receive a refund, store credit or product exchange (e.g. a replacement with another Suntegrity Face SPF product).
• If you purchased this product from a retailer: If you would like an exchange option (5-in-1 Tinted Sunscreen + free gift), you may contact Suntegrity directly via email at ImpeccableSkinRecall@SuntegritySkincare.com. If you prefer a store credit, please contact the retailer from whom you originally purchased the product. In either case, you 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.

Consumers with questions regarding this recall can contact Suntegrity Skincare via email at ImpeccableSkinRecall@SuntegritySkincare.com. Emails will be responded to as quickly as possible M-F between 9am and 5pm Pacific Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using this over-the-counter sunscreen drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Complete and submit the report Online
• Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.