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
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0589-2024 |
| Event ID | 94737 |
| Brand | IMPECCABLE SKIN - IVORY |
| Generic Name | ZINC OXIDE |
| Manufacturer | ZINC OXIDE |
| Original Package? | 1 |
| Active Substance | ZINC OXIDE |
| Drug Route | TOPICAL |
| Distribution | Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan |
| Quantity | 8202 tubes |
| Recall Reason | CGMP Deviations |
| Drug Classification | Class II |
| Drug Code Info | 20240717 |
| Product NDC | 69949-151 69949-152 69949-153 |
| Drug UPC | 854245006170 854245006224 854245006187 |
| Recall Initiation Date | 20240524 |
| Report Date | 20240717 |
| Classification Date | 20240708 |
| Address | 2411 Tech Center Ct Ste 104N/A Las Vegas, NV 89128-0805 United States |
| Recalling Firm | SYNCHRONICITY SPA INC, DBA SUNTE |
| Initial Notification | Letter |
| Unique Ingredient Identifier | SOI2LOH54Z |
| Drug Application Number | M020 |
| 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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