Impeccable Skin - Ivory Cream
FDA Recall NDC 69949-151
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Impeccable Skin - Ivory (NDC 69949-151). A significant event, classified as Class I, was initiated on May 24, 2024 by Synchronicity Spa, Inc. Dba Suntegrity. The reported reason for this action was: "Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)"
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class I Ongoing
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
May 24, 2024
Jul 17, 2024
1,902 tubes
Recall Profile & Regulatory Data
Event ID
94737
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
SYNCHRONICITY SPA INC, DBA SUNTE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
Product Description
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, NDC: 69949-152-01 UPC 854245006187
Batch or Lot Expiration Information
Lot# : 115BU, Exp: 06/30/2025
Affected Packages Involved in this Recall
69949-151-01Product
69949-152-01Product
69949-153-01Product
69949-154-01Product
69949-155-01Product
69949-156-01Product
69949-157-01Product
8542450061Product
Class II Ongoing
CGMP Deviations
May 24, 2024
Jul 17, 2024
8202 tubes
Recall Profile & Regulatory Data
Event ID
94737
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
SYNCHRONICITY SPA INC, DBA SUNTE
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
Product Description
suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Suntegrity Skincare, Las Vegas, NV 89128, a) NDC: 69949-151-01, UPC: 854245006170 - IVORY b) NDC: 69949-156-01, UPC: 854245006224 - NUDE c) NDC: 69949-152-01, UPC: 854245006187 - BUFF d) NDC: 69949-153-01, UPC: 854245006194 - SAND e) NDC: 69949-155-01, UPC: 854245006217 - BRONZE f) NDC: 69949-157-01, UPC: 854245006446 - MOCHA
Batch or Lot Expiration Information
Lot# Lot: a) 107IV, Exp: 04/30/2025 b) 107NU, Exp: 06/30/2025; 109NU, Exp: 10/31/2025 c) 117BU, Exp: 10/31/2025 d) 113SA, Exp: 06/30/2025; 114SA, Exp: 10/31/2025 e) 106BR, Exp: 04/30/2025; f) 101MO, Exp: 05/31/2025
Affected Packages Involved in this Recall
69949-151-01Product
69949-152-01Product
69949-153-01Product
69949-154-01Product
69949-155-01Product
69949-156-01Product
69949-157-01Product
8542450061Product
8542450062Product
8542450064Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
