suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shades, Broad… recall
FDA recall D-0589-2024 · initiated May 24, 2024
SYNCHRONICITY SPA INC, DBA SUNTE recalled suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shad… in May 2024 — an FDA Class II recall (D-0589-2024) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
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: 8202 tubes
Details
- Product
- 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
- Recalling company
- SYNCHRONICITY SPA INC, DBA SUNTE
- Classification
- Class II
- 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, Multiple Shad… recalled?
- SYNCHRONICITY SPA INC, DBA SUNTE recalled suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shad… in May 2024 — an FDA Class II recall (D-0589-2024) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shad… recalled?
- Per the FDA enforcement record, the reason for recall D-0589-2024 was: CGMP Deviations
- Is a recalled suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, Multiple Shad… 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. May cause temporary or medically reversible harm; low probability of serious harm. 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, Multiple Shad… 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: a) 107IV, Exp: 04/30/2025 b) 107NU, Exp: 06/30/2025; 109NU, Exp: 10/31/2025 c) 117BU, Exp: 10/31/2025 d) 113SA, Exp: 06/30/2025; 114SA, Exp: 10/31/2025 e) 106BR, Exp: 04/30/2025; f) 101MO, Exp: 05/31/2025. 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-0589-2024.