Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1
Summary
The FDA issued a Class I for Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, by Beiersdorf Inc. Reason: Chemical contamination; presence of benzene.
Details
Source
Drug Recall
External ID
D-0014-2022
Action Date
2021-10-27
Status
Terminated
Category
drug
Product Description
Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 5%, NET WT 1.6 OZ (45 g) can, Beiersdorf Inc., Wilton, CT 06897 UPC 0 41100 00506 9
Lot/Code Info: Lot# TN00BU3, exp. date 05/31/2024
Quantity Affected: 143,376 cans
Reason for Recall
Chemical contamination; presence of benzene
Distribution
Nationwide in the US
Type: Voluntary: Firm initiated
Recall Initiated: 2021-09-30
Company
Wilton, CT
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 32 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Beiersdorf Inc has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Beiersdorf Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Beiersdorf Inc have FDA actions?
Beiersdorf Inc has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0014-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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