Drug FDA Class I Ongoing Contamination / non-sterility

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

SYNCHRONICITY SPA INC, DBA SUNTE Published Jul 17, 2024

Risk level

Class I

Dangerous or defective — could cause serious health problems or death.

Severity score 85/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact SYNCHRONICITY SPA INC, DBA SUNTE or your place of purchase with questions, and see the source record below for full details.

Reason for recall

Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold)

Hazards

Aspergillus Sydowii · primary

Affected products (1)

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

IMPECCABLE SKIN - IVORY · 1,902 tubes

NDC: 69949-151, 69949-152, 69949-153, 69949-154, 69949-155, 69949-156, 69949-157, 69949-151-01, 69949-152-01, 69949-153-01, 69949-154-01, 69949-155-01, 69949-156-01, 69949-157-01, 8542450061

Code info: Lot#: 115BU, Exp: 06/30/2025;

Affected areas

Nationwide

Timeline

Initiated

May 24, 2024
Published

Jul 17, 2024

Recall number: D-0588-2024
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.