suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SP… recall
FDA recall D-0588-2024 · initiated May 24, 2024
SYNCHRONICITY SPA INC, DBA SUNTE recalled suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad S… in May 2024 — an FDA Class I recall (D-0588-2024) because Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold).
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,902 tubes
Details
- Product
- 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
- Recalling company
- SYNCHRONICITY SPA INC, DBA SUNTE
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- 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
- Initiated
- May 24, 2024
- FDA report date
- Jul 17, 2024
Frequently asked
- Was suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad S… recalled?
- SYNCHRONICITY SPA INC, DBA SUNTE recalled suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad S… in May 2024 — an FDA Class I recall (D-0588-2024) because Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold). Most serious — a reasonable probability that use will cause serious harm or death.
- Why was suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad S… recalled?
- Per the FDA enforcement record, the reason for recall D-0588-2024 was: Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)
- Is a recalled suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad S… dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad S… are affected?
- 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. The recall covers these lots — Lot#: 115BU, Exp: 06/30/2025;. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0588-2024.