PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported March 14, 2018

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.

Labeling: Label mix-up

Recall #
D-0590-2018
Affected scope
528 units
Initiated
February 23, 2018
Verify with FDA Drug →
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Bayer HealthCare Pharmaceuticals, Inc. recalled Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylen… - a moderate-severity action.

Coppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylen… was recalled by Bayer HealthCare Pharmaceuticals, Inc. in March 14, 2018. Reason: Labeling: Label mix-up. Check the official notice for the remedy. Verify recall #D-0590-2018 with the FDA Drug before acting.

The recall

Bayer HealthCare Pharmaceuticals, Inc. issued this moderate-severity FDA Drug recall-Labeling: Label mix-up.

Moderate
severity level
528 units
affected scope
Class II
classification
March 14, 2018
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0590-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 1 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,781 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 196
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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.

Reason for recall

Labeling: Label mix-up

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-0590-2018
Date reported March 14, 2018
Date initiated February 23, 2018
Recalling firm Bayer HealthCare Pharmaceuticals, Inc.
Firm location Whippany, NJ
Affected scope 528 units
Distribution Arkansas only

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

528 units units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) -
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0590-2018) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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.. Recalled by Bayer HealthCare Pharmaceuticals, Inc.. Units affected: 528 units.
Why was this product recalled?
Labeling: Label mix-up
Which agency issued this recall?
This recall was issued by the FDA Drug on March 14, 2018. Severity: Moderate. Recall number: D-0590-2018.
Where was the recalled product distributed?
Distribution: Arkansas only.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per … → · All Children & Baby Products recalls

This recall: FDA Drug, reported March 14, 2018. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026