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ZINC OXIDE Recall D-0589-2024

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

ZINC OXIDE Recall D-0589-2024 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-0589-2024
Event ID94737
BrandIMPECCABLE SKIN - IVORY
Generic NameZINC OXIDE
ManufacturerZINC OXIDE
Original Package?1
Active SubstanceZINC OXIDE
Drug RouteTOPICAL
DistributionDistributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
Quantity8202 tubes
Recall ReasonCGMP Deviations
Drug ClassificationClass II
Drug Code Info20240717
Product NDC69949-151 69949-152 69949-153
Drug UPC854245006170 854245006224 854245006187
Recall Initiation Date20240524
Report Date20240717
Classification Date20240708
Address2411 Tech Center Ct Ste 104N/A
Las Vegas, NV 89128-0805
United States
Recalling FirmSYNCHRONICITY SPA INC, DBA SUNTE
Initial Notification Letter
Unique Ingredient IdentifierSOI2LOH54Z
Drug Application NumberM020
Structured Product Labeling (SPL ID)9013d884-7a0e-4316-960d-a49cdffccf02
Structured Product Labeling (SPL Set ID)98a7896e-4b03-4184-ac2e-6b49e47c0bc4
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