CLASS II Drug recall · Reported 27 Oct 2021 · FDA Enforcement Report
Coppertone Pure & Simple baby 50 Sunscreen Spray recalled by Beiersdorf
Beiersdorf is recalling Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 08%, distributed nationwide in the US. The recall was initiated on 30 Sep 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0017-2022
- FDA event ID
- 88770
- Recalling firm
- Beiersdorf, Wilton, CT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Sep 2021
- FDA classified
- 15 Oct 2021
- Reported
- 27 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Sunscreen & Personal Care
Timeline
| 30 Sep 2021 | Recall initiated by company | |
| 15 Oct 2021 | Classified by FDA | +15 days |
| 27 Oct 2021 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations
Product as listed by the FDA
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
Where it was distributed
Nationwide in the US
Questions about this recall
Is Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 08% recalled?
Yes. Beiersdorf recalled Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 08% on 30 Sep 2021. The recall is Class II and its status is Terminated. Recall number D-0017-2022.
Why was it recalled?
cGMP Deviations
Which lots are affected?
Lot# TN009GH, 03/31/2023
Where was it sold?
Nationwide in the US
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Beiersdorf
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Coppertone Pure & Simple 50 Sunscreen Spray recalled by Beiersdorf | Beiersdorf | Benzene | Nationwide |
| Drug | CLASS II | Coppertone Pure & Simple kids 50 Sunscreen Spray recalled by Beiersdorf | Beiersdorf | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Coppertone Pure & Simple baby 50 Sunscreen Spray recalled by Beiersdorf | Beiersdorf | Benzene | Nationwide |
| Drug | CLASS I | Coppertone Sport Sunscreen Spray recalled by Beiersdorf | Beiersdorf | Benzene | Nationwide |
| Drug | CLASS I | Coppertone Pure & Simple kids 50 Sunscreen Spray recalled by Beiersdorf | Beiersdorf | Benzene | Nationwide |