VerifyRecall
Alerts
ACTIVE RECALL — CLASS IIActive recallD-0849-2016/FDA enforcement
Sesderma, Sl·Cosmetics·Oct 15, 2015

Repaskin 30 (Octacrylene 4%, Oxybenzone 3%, Octisalate 3%, Octinoxate 3% Avobenzone 3%) Facial…

What you need to know

Class II

  • What happened

    CGMP Deviations; product does not comply with cGMP requirements

  • Health risk

    The product may cause temporary or medically reversible health consequences, or the probability of serious harm is remote. Current good manufacturing practice failures can affect product identity, strength, quality or purity.

  • 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.

Active recall · classified by the FDAFL, PR, CO, GAMore cosmetics

Advertisement

Ad

Know someone who bought this?

A quick share can keep a pantry check from becoming a missed warning.

Share via WhatsApp

Match before you discard

Product identification

Source: FDA COSMETICS

Brand nameSesderma, Sl
Recalling firmSesderma, SlRafelbunol, Spain
UPC / barcodesNo UPC listed in the FDA enforcement record.
Lot / date codes
  • Lot code 51064901, exp 07/17
  • Lot code 51064902, exp 04/18
Distribution area
FLPRCOGA

Distributed to following states: FL, PR, CO, GA.

United States

Quantity affected27 bottles
Recall initiationFDA report date: May 18, 2016
FDA recall numberD-0849-2016

Beyond the headline

The recall, in context

Sesderma, Sl initiated this cosmetics recall on October 15, 2015. The FDA enforcement report states: CGMP Deviations; product does not comply with cGMP requirements. The FDA report lists distribution as: Distributed to following states: FL, PR, CO, GA.

The FDA enforcement report describes the reason as: CGMP Deviations; product does not comply with cGMP requirements

Repaskin 30 (Octacrylene 4%, Oxybenzone 3%, Octisalate 3%, Octinoxate 3% Avobenzone 3%) Facial… was made or distributed by Sesderma, Sl in Rafelbunol, Spain. This page reflects FDA report D-0849-2016, dated May 18, 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, current good manufacturing practice failures can affect product identity, strength, quality or purity.

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 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 Repaskin 30 (Octacrylene 4%, Oxybenzone 3%, Octisalate 3%, Octinoxate 3% Avobenzone 3%) Facial… recall?

Sesderma, Sl recalled Repaskin 30 (Octacrylene 4%, Oxybenzone 3%, Octisalate 3%, Octinoxate 3% Avobenzone 3%) Facial… in an FDA Class II enforcement action reported as D-0849-2016. CGMP Deviations; product does not comply with cGMP requirements

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 Sesderma, Sl recall still active?

Yes. As of the latest FDA enforcement report, this recall is listed as ongoing. Check the official source record for the most current status before making a decision.

Where can I verify this recall?

This page is normalized from the openFDA enforcement record D-0849-2016. 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

Brand history

More recalls by Sesderma, Sl

View brand
Class II·

Sesderma, Sl

Repaskin 50 (Octocrylene 7%, Titanium Dioxide 2%) Body Lotion Sunscreen Gel Cream, Broad…

CGMP Deviations; product does not comply with cGMP requirements

FL, PR, CO +1 moreCosmetics
Class II·

Sesderma, Sl

Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on, 2.5 FL OZ (75 ML) Bottle, Over The…

CGMP Deviations; product does not comply with cGMP requirements

FL, PR, CO +1 moreCosmetics

Related alerts

Recent cGMP deviations recalls

All alerts
Class II·

Shantou Qiwei Industrial Co., LTD

Menow Sunscreen Pressed Powder SPF35 Pa+++, NET Content, 9g/0.32 OZ, Manufactured by: Shantzu…

CGMP Deviations

CACosmetics
Class II·

Wellnov Supplements LLC

Liposomal Women's Liquid Multivitamin Drops with Iron

Deviations from current Good Manufacturing Practices (cGMP) that could lead to bacterial pathogen and possible C. Botulinum concerns.

Nationwide (US) +1 countriesFood

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