CLASS I ONGOING Drug recall · Reported 17 Jul 2024 · FDA Enforcement Report
suntegrity, (Zinc Oxide 15%) Impeccable Skin sunscreen recalled
Synchronicity SPA Inc is recalling suntegrity, (Zinc Oxide 15%) Impeccable Skin sunscreen foundation, Buff, Broad Spectrum, distributed nationwide in the US. The recall was initiated on 24 May 2024 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0588-2024
- FDA event ID
- 94737
- Recalling firm
- Synchronicity SPA Inc, Las Vegas, NV
- Manufacturer
- Synchronicity Spa, Inc. DBA Suntegrity
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 24 May 2024
- FDA classified
- 8 Jul 2024
- Reported
- 17 Jul 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Drug class
- Sunscreen & Personal Care
Timeline
| 24 May 2024 | Recall initiated by company | |
| 8 Jul 2024 | Classified by FDA | +45 days |
| 17 Jul 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Product as listed by the FDA
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
Where it was distributed
Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Which lots are affected?
Lot#: 115BU, Exp: 06/30/2025;
Where was it sold?
Distributed Nationwide in the USA and Queensland, Christchurch, Ontario, Quebec, Alberta, British Columbia Cayman Islands, Bermuda, France, Amsterdam, Hants, Dubai, Hong Kong, Singapore, Taiwan
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 94737This product is part of a recall event; the main page for the event is suntegrity, (Zinc Oxide 15%) Impeccable Skin sunscreen recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | suntegrity, (Zinc Oxide 15%) Impeccable Skin sunscreen recalledImpeccable Skin - Ivory | Synchronicity SPA Inc | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Synchronicity SPA Inc
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | suntegrity, (Zinc Oxide 15%) Impeccable Skin sunscreen recalledImpeccable Skin - Ivory | Synchronicity SPA Inc | Manufacturing (CGMP) Deviations | Nationwide |
Other Zinc Oxide recalls
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | WeCare, Zinc Oxide Ointment recalled by Blossom PharmaceuticalsZinc Oxide | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nivagen, Zinc Oxide Ointment recalled by Blossom PharmaceuticalsNivagen Zinc Oxide | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 % recalledNivagen Zinc Oxide | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Dynashield cream recalled by Blossom PharmaceuticalsDynashield | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Dynashield Skin Protectant recalled by Blossom PharmaceuticalsDynashield | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |