Suntegrity recalled over sterility concerns

Recall date

May 24, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

SYNCHRONICITY SPA INC, DBA SUNTE recalls suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broad Spectrum SPF30, Net WT 2OZ (56.7 g), Sun…

Recall number

D-0588-2024

FDA classification

Class I

Brand / firm

SYNCHRONICITY SPA INC, DBA SUNTE

Sold / 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

Why it was recalled

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

Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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