CLASS II Drug recall · Reported 14 Mar 2018 · FDA Enforcement Report
Coppertone Kids Sunscreen Spray (avobenzone recalled by Bayer HealthCare
Bayer HealthCare Pharmaceuticals is recalling Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, distributed in Arkansas. The recall was initiated on 23 Feb 2018 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-0590-2018
- FDA event ID
- 79252
- Recalling firm
- Bayer HealthCare Pharmaceuticals, Whippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2018
- FDA classified
- 12 Mar 2018
- Reported
- 14 Mar 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Sunscreen & Personal Care
Timeline
| 23 Feb 2018 | Recall initiated by company | |
| 12 Mar 2018 | Classified by FDA | +17 days |
| 14 Mar 2018 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label mix-up
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.
Where it was distributed
Arkansas only
Questions about this recall
Why was it recalled?
Labeling: Label mix-up
Which lots are affected?
Lot#: 7N04CS, 7N05CS, Exp. 11/2019
Where was it sold?
Arkansas only
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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