FDA MedWatch - Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) by Suntegrity Skincare

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TOPIC: Suntegrity Impeccable Skin Sunscreen Foundation (Multiple Shades) by Suntegrity Skincare: Recall - Due to Microbial Contamination

AUDIENCE: Consumer, Health Professional, Dermatology, Pharmacy

ISSUE: Suntegrity Skincare is recalling 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.

To date, no adverse event reports had been received at the time of the recall.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: Suntegrity Impeccable Skin Sunscreen Foundation is labelled to help prevent sunburn.

RECOMMENDATIONS: 

• 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.

• All Consumers/distributors/retailers that have subject product 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. 

  • 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. 

• Consumers with questions regarding this recall can contact Suntegrity Skincare via email at ImpeccableSkinRecall@SuntegritySkincare.com.

Health professionals and consumers are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report online.
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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