PlainRecalls
FDA Drug Low Class III Terminated

festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China

Reported: August 7, 2019 Initiated: April 1, 2019 #D-1533-2019

Product Description

festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China

Reason for Recall

CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.

Details

Units Affected
20, 000
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.
Location
Yuyao, N/A

Frequently Asked Questions

What product was recalled?
festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ingredients Octinoxate 7.5%, Octisalate 2.0%, Oxybenzone 4.0% Titanium Dioxide 2.5% Sunscreen Distributed by: festpak - Austin, TX 78732 Made in China. Recalled by NingBo Huize Commodity Co.,Ltd.. Units affected: 20, 000.
Why was this product recalled?
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Which agency issued this recall?
This recall was issued by the FDA Drug on August 7, 2019. Severity: Low. Recall number: D-1533-2019.