Coppertone Pure & Simple Baby 50 Sunscreen Spray Recalled for cGMP Deviations
Beiersdorf Inc. is recalling 14,748 cans of Coppertone Pure & Simple baby 50 Sunscreen Spray due to cGMP (current Good Manufacturing Practice) deviations. The product was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries, and the hazard identified is a manufacturing practice deviation rather than a direct product contamination or safety defect. The source text does not report any actual harm to consumers.
Plain-English summary
Beiersdorf Inc., located in Wilton, Connecticut, is recalling Coppertone Pure & Simple baby 50 Sunscreen Spray (Zinc Oxide 24.08%, 5 oz cans) due to cGMP deviations. The affected lot is Lot# TN009GH, with an expiration date of 03/31/2023. The recall involves 14,748 cans that were distributed nationwide in the United States.
The recall was initiated voluntarily by the firm on September 30, 2021, and was terminated on April 13, 2023. The reason for the recall is failures to comply with current Good Manufacturing Practice requirements. The FDA classified this as a Class II recall on October 15, 2021.
Consumers who have this product should discontinue use. The product is identified by UPC 0 72140 02881 7.
The recalled product
- Product
- Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, NET WT 5 OZ (142 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 72140 02881 7
- Manufacturer
- Beiersdorf Inc
- Category
- Drug — Sunscreen
- Affected units
- 14,748
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# TN009GH
- 03/31/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Beiersdorf Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 8 products in this recall →Related recalls
Same manufacturer · Beiersdorf Inc
See all →- SevereCoppertone Pure & Simple Baby Sunscreen Spray Recalled for Benzene Contamination
FDA (Drugs) · 2021-10-27
- CriticalCoppertone Pure & Simple 50 Sunscreen Spray Recalled for Benzene Contamination
FDA (Drugs) · 2021-10-27
- ModerateCoppertone Pure & Simple Kids 50 Sunscreen Spray Recalled for cGMP Deviations
FDA (Drugs) · 2021-10-27
- SevereCoppertone Pure & Simple Kids 50 Sunscreen Spray Recalled for Benzene Contamination
FDA (Drugs) · 2021-10-27
- SevereCoppertone SPORT MINERAL 50 Sunscreen Spray Recalled for Benzene Contamination
FDA (Drugs) · 2021-10-27
Same hazard · cgmp deviation
See all →- ModeratePritam International Recalls Brush Buddies Toothpaste Due to CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModerateARU Toothpaste Recalled for CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls Brush Buddies Fluoride Toothpaste for CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls Brush Buddies Toothpaste Due to CGMP Deviations
FDA (Drugs) · 2026-10-28
- ModeratePritam International Recalls My Little Pony Toothpaste for CGMP Deviations
FDA (Drugs) · 2026-10-28
Similar recalls
- ModerateBayer Recalls Coppertone Kids Sunscreen Spray Due to Labeling Error
FDA (Drugs) · 2018-03-14
- ModerateBayer Recalls Coppertone Sunscreen Lotion for Undeclared Oxybenzone
FDA (Drugs) · 2016-06-15
- ModerateNeutrogena Beach Defense Sunscreen Spray Recalled for cGMP Deviations
FDA (Drugs) · 2021-10-06
- ModerateCLEARSTEM sunscreen recalled over current good manufacturing practice deviations
FDA (Drugs) · 2025-12-03
- ModerateNeutrogena COOLDRY SPORT Sunscreen Spray Recalled Due to cGMP Deviations
FDA (Drugs) · 2021-10-06
- ModerateNeutrogena Beach Defense SPF 100 sunscreen spray recalled for cGMP deviations
FDA (Drugs) · 2021-10-06