RECALL RECORD — CLASS IIIRecall closedD-0341-2019/FDA enforcement

Advanced Protection Sunscreen SPF 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5…

What you need to know

Class III
  • What happened

    Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.

  • Health risk

    The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. 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 FDADistribution not listedMore cosmetics

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Product identification

Source: FDA COSMETICS

Brand nameCbi Laboratories, INC.
Recalling firmCbi Laboratories, INC.Fort Worth, TX, United States
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • Lot #: 131965, Exp 12/2018; 127426 Exp. 01/2019; 129045, 130424 Exp. 06/2019; 130432 Exp. 10/2019; 131870 Exp. 06/2019; 132648, Exp. 03/2020
  • 133732 Exp. 04/2020; 134400 Exp. 02/2020; 135345 Exp. 08/2020
Distribution area

United States, Maldives, Canada, United Arab Emirates, and New Zealand

United States, Canada

Quantity affected5363 tubes
Recall initiationFDA report date: December 26, 2018
FDA recall numberD-0341-2019

Beyond the headline

The recall, in context

Cbi Laboratories, INC. initiated this cosmetics recall on December 10, 2018. The FDA enforcement report states: Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients. The FDA report lists distribution as: United States, Maldives, Canada, United Arab Emirates, and New Zealand.

The FDA enforcement report describes the reason as: Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.

Advanced Protection Sunscreen SPF 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5… was made or distributed by Cbi Laboratories, INC. in Fort Worth, TX, United States. This page reflects FDA report D-0341-2019, dated December 26, 2018.

Why this is a Class III recall

Class III means the product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. In this recall, the product may not deliver the sun protection stated on its label, increasing the risk of sunburn and UV exposure.

FDA definition

The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations.

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 lot and date codes 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

Product safety recall

Symptoms to watch for

The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.

Higher-risk groups

Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.

What to do now

  1. 1Stop using or eating the product and keep it away from children and pets.
  2. 2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
  3. 3Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Read the official source record for the specific hazard and instructions.

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 Advanced Protection Sunscreen SPF 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5… recall?

Cbi Laboratories, INC. recalled Advanced Protection Sunscreen SPF 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5… in an FDA Class III enforcement action reported as D-0341-2019. Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.

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. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.

Is the Cbi Laboratories, INC. 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-0341-2019. 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

Brand history

More recalls by Cbi Laboratories, INC.

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