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RECALL RECORD — CLASS IIRecall closedD-0977-2016/FDA enforcement
Bayer Health Care LLC·Cosmetics·May 10, 2016

Coppertone Sunscreen Lotion, Clearly Sheer, Broad Spectrum SPF 50, 5 FL OZ (147ml), OTC, Dist…

What you need to know

Class II

  • What happened

    Labeling; Product Contains Undeclared API (Oxybenzone)

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. The product may not deliver the sun protection stated on its label, increasing the risk of sunburn and UV exposure.

  • Action required

    Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement.

Recall closed · classified by the FDANationwide (US)More cosmetics

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Product identification

Source: FDA COSMETICS

Brand nameBayer Health Care LLC
Recalling firmBayer Health Care LLCCleveland, TN, United States
UPC / barcodes
00 041100 00576 2
Lot / date codes
  • CV006V9, 2/2018
Distribution area
Nationwide

Nationwide

United States

Quantity affected37, 512 bottles
Recall initiationFDA report date: June 15, 2016
FDA recall numberD-0977-2016

Beyond the headline

The recall, in context

Bayer Health Care LLC initiated this cosmetics recall on May 10, 2016. The FDA enforcement report states: Labeling; Product Contains Undeclared API (Oxybenzone). The FDA report lists distribution as: Nationwide.

The FDA enforcement report describes the reason as: Labeling; Product Contains Undeclared API (Oxybenzone)

Coppertone Sunscreen Lotion, Clearly Sheer, Broad Spectrum SPF 50, 5 FL OZ (147ml), OTC, Dist… was made or distributed by Bayer Health Care LLC in Cleveland, TN, United States. This page reflects FDA report D-0977-2016, dated June 15, 2016.

Why this is a Class II recall

Class II means the product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. In this recall, an allergen that is present but missing or incorrect on the label can cause a serious reaction in allergic consumers.

FDA definition

The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote.

What to do now

  1. 1

    Stop using it

    Set the product aside and do not apply it.

  2. 2

    Check the codes

    Compare the UPC and lot code against the table above.

  3. 3

    Return or discard

    Contact the retailer or recalling firm about a refund, and dispose of the product safely.

Consumer safety guide

Undeclared allergen

Symptoms to watch for

Hives, swelling, wheezing, coughing, vomiting, abdominal pain or a drop in blood pressure. Anaphylaxis is a medical emergency.

When symptoms may appear

Allergic reactions often begin within minutes to a few hours of eating the allergen.

Higher-risk groups

Anyone with a diagnosed food allergy, especially children, and people with a history of anaphylaxis or asthma.

What to do now

  1. 1Do not eat or serve the affected product if you or anyone in the household has a diagnosed allergy.
  2. 2If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services.
  3. 3Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

For a severe allergic reaction, do not wait for a callback or refund process before seeking emergency care.

This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.

Frequently asked

Questions about this recall

What is the Coppertone Sunscreen Lotion, Clearly Sheer, Broad Spectrum SPF 50, 5 FL OZ (147ml), OTC, Dist… recall?

Bayer Health Care LLC recalled Coppertone Sunscreen Lotion, Clearly Sheer, Broad Spectrum SPF 50, 5 FL OZ (147ml), OTC, Dist… in an FDA Class II enforcement action reported as D-0977-2016. Labeling; Product Contains Undeclared API (Oxybenzone)

What should I do if I bought this product?

Stop applying or using the product. Check the UPC and lot codes below, then return it to the retailer or contact the manufacturer about a refund or replacement. Do not eat or serve the affected product if you or anyone in the household has a diagnosed allergy. If symptoms such as swelling, wheezing or breathing difficulty occur, use the person's prescribed emergency plan and call emergency services. Keep the packaging, contact the retailer or manufacturer for a refund, and read the official recall notice for the exact allergen.

Is the Bayer Health Care LLC recall still active?

The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record D-0977-2016. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.

Verify before you act.

VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.

Official source

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Nationwide (US)Cosmetics

Record last synced from official openFDA enforcement data on November 14, 2026. Source record: official FDA notice.