Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
suntegrity (Zinc Oxide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
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
Affected NDCs
69949-0151-01
69949-0152-01
69949-0153-01
69949-0155-01
69949-0156-01
69949-0157-01
Compare with the code on your package — it is the most precise check available.
Drug: Zinc
Product details
From the FDA NDC directory, for the product codes this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Impeccable Skin - Ivory Zinc Oxide NDC 69949-0151 |
150 mg/g | Cream Topical |
Synchronicity Spa, Inc. DBA Suntegrity | OTC |
| Impeccable Skin - Buff Zinc Oxide NDC 69949-0152 |
150 mg/g | Cream Topical |
Synchronicity Spa, Inc. DBA Suntegrity | OTC |
| Impeccable Skin - Sand Zinc Oxide NDC 69949-0153 |
150 mg/g | Cream Topical |
Synchronicity Spa, Inc. DBA Suntegrity | OTC |
| Impeccable Skin - Bronze Zinc Oxide NDC 69949-0155 |
150 mg/g | Cream Topical |
Synchronicity Spa, Inc. DBA Suntegrity | OTC |
| Impeccable Skin - Nude Zinc Oxide NDC 69949-0156 |
150 mg/g | Cream Topical |
Synchronicity Spa, Inc. DBA Suntegrity | OTC |
| Impeccable Skin - Mocha Zinc Oxide NDC 69949-0157 |
150 mg/g | Cream Topical |
Synchronicity Spa, Inc. DBA Suntegrity | OTC |
- Recalling firm
- Synchronicity Spa INC, Dba Sunte
- Origin
- NV, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Jun 11, 2024 · FDA notice with lot numbers
- FDA recall number
- D-0589-2024 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
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Class I · High risk
suntegrity
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