FDA Recall D-0589-2024

SYNCHRONICITY SPA INC, DBA SUNTE · Las Vegas, NV

Class II Ongoing 720 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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

Quantity: 8202 tubes

Reason for recall

CGMP Deviations

Recall record

Recall number: D-0589-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
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
Recall initiated: 2024-05-24
Classified by FDA Center: 2024-07-08
FDA published: 2024-07-17
Recalling firm: SYNCHRONICITY SPA INC, DBA SUNTE
Firm location: Las Vegas, NV

Drug identification

Brand name(s): IMPECCABLE SKIN - IVORY
Generic name(s): ZINC OXIDE
Manufacturer(s): Synchronicity Spa, Inc. DBA Suntegrity
NDC(s): 69949-151, 69949-152, 69949-153, 69949-154, 69949-155, 69949-156, 69949-157
Route(s): TOPICAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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