OTC Sunscreen Foundation Recalled for Fungal Mold Contamination
Suntegrity IMPECCABLE SKIN sunscreen foundation is recalled for microbial contamination with Aspergillus Sydowii mold. Consumers should discontinue use immediately.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification applies to this recall. The rubric mandates that if the agency's own classification is FDA Class I, the severity score must be at least 4. No illnesses or deaths have been reported, which prevents a Critical rating, but the Class I status requires a Severe classification.
Plain-English summary
The FDA is recalling 1,902 tubes of IMPECCABLE SKIN - IVORY sunscreen foundation (Zinc Oxide 15%, SPF 30, 2 oz) manufactured by Synchronicity Spa Inc. DBA Suntegrity. The affected product has lot number 115BU with an expiration date of June 30, 2025 (NDC 69949-152-01, UPC 854245006187).
This recall is due to microbial contamination of the non-sterile product. Aspergillus Sydowii (mold) was detected in the product.
This product was distributed nationwide throughout the United States and internationally to Canada, Cayman Islands, Bermuda, France, and Asia-Pacific regions. Consumers should stop using this product immediately.
If you have this product, do not use it and contact Synchronicity Spa Inc. DBA Suntegrity for further information. Consult a healthcare provider if you have any health concerns related to use of this product.
The recalled product
- Product
- IMPECCABLE SKIN - IVORY (ZINC OXIDE)
- Brand
- IMPECCABLE SKIN - IVORY
- Manufacturer
- SYNCHRONICITY SPA INC, DBA SUNTE
- Category
- Drug — Topical Sunscreen
- Affected units
- 1,902
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: 115BU
- Exp: 06/30/2025
UPCs (1)
- 854245006187
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by SYNCHRONICITY SPA INC, DBA SUNTE under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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