Medications & Supplements/Topical Products

Sesderma, SL: Various Sunscreens and Skincare Products Recalled for Manufacturing Deviations

Agency Publication Date: October 11, 2018

Summary

Sesderma, SL is recalling approximately 1,767 units of various over-the-counter drug products, including Dryses antiperspirants, Salises acne treatment gel, Repaskin sunscreens, and Screenses tinted compacts. These products were manufactured in Spain and distributed in Florida, Puerto Rico, Colorado, and Georgia. The recall was initiated because the products do not comply with Current Good Manufacturing Practice (cGMP) requirements, which are the federal standards for ensuring product quality and safety during production.

Risk

Failure to follow Good Manufacturing Practices means the quality, purity, and potency of these medications cannot be guaranteed, potentially leading to ineffective treatment or skin irritation.

What You Should Do

Check your product packaging for the brand names Dryses, Salises, Repaskin, or Screenses and match the specific NDC or UPC codes provided in the product list.
Identify your specific lot number and expiration date, such as Dryses Antiperspirant lot 40444601 (Exp 01/2019) or Salises Acne Gel lot 51004101 (Exp 2/2020).
Stop using the affected product immediately if it matches the identified lot numbers and expiration dates.
Contact your healthcare provider or pharmacist for guidance regarding the use of these topical treatments.
Return any unused product to the place of purchase for a refund and contact Sesderma, SL for further instructions.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Drug product return/refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Dryses Aluminum Chlorohydrate Antiperspirant Solution (3.4 fl. oz)

Model:

NDC 63181-0015-1

UPC Codes:

8470003244268

Lot Numbers:

40444601 (Exp 01/2019)

41414601 (Exp 05/2019)

40024602 (Exp 12/2018)

Product: Salises Facial Moisturizing Acne Treatment Gel (1.7 fl. oz)

Model:

NDC 63181-0016

Lot Numbers:

51004101 (Exp 2/2020)

43394101 (Exp 11/2019)

33444101 (Exp 11/2018)

Product: Repaskin 50 Body Lotion Sunscreen gel cream (6.8 fl oz)

Model:

NDC 63181-0013-1

UPC Codes:

8429979415707

Lot Numbers:

41464901 (Exp 05/17)

Product: Repaskin 30 Body Lotion Sunscreen gel cream (6.8 fl oz)

Model:

NDC 63181-0012-1

UPC Codes:

8429979415691

Lot Numbers:

41274901 (Exp 2/19)

Product: Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on (2.5 fl oz)

Model:

NDC 63181-0019-1

UPC Codes:

8470002075221

Lot Numbers:

40414701 (Exp 09/19)

33524701 (Exp 10/18)

40144101 (Exp 10/18)

Product: Dryses Aluminum Chlorohydrate Deodorant for Women Roll-on (2.5 fl oz)

Model:

NDC 16047-0029-1

Lot Numbers:

33454701 (Exp 11/18)

40424701 (Exp 1/2019)

Product: Repaskin 50 Facial Sunscreen gel cream (1.7 fl oz)

Model:

NDC 63181-0011-1

Lot Numbers:

51594901 (Exp 06/18)

Product: Repaskin 30 Facial Sunscreen gel cream (1.7 fl oz)

Model:

NDC 63181-0010-1

Lot Numbers:

51064901 (Exp 07/17)

51064902 (Exp 04/18)

Product: Screenses Color Sunscreen Tinted compact Brown (0.35 oz)

UPC Codes:

8429979252166

Lot Numbers:

H-04 (Exp 07/2019)

Product: Screenses Color Sunscreen Tinted compact Light (0.35 oz)

UPC Codes:

8429979252159

Lot Numbers:

H04.2 (Exp 11/2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73574

Status: Active

Manufacturer: Sesderma, SL

Sold By: specialty retailers

Manufactured In: Spain

Units Affected: 10 products (542 bottles; 459 bottles; 15 bottles; 20 bottles; 354 bottles; 195 bottles; 66 bottles; 27 bottles; 45 compacts; 44 compacts)

Distributed To: Florida, Puerto Rico, Colorado, Georgia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Check your product packaging for the brand names Dryses, Salises, Repaskin, or Screenses and match the specific NDC or UPC codes provided in the product list.

Identify your specific lot number and expiration date, such as Dryses Antiperspirant lot 40444601 (Exp 01/2019) or Salises Acne Gel lot 51004101 (Exp 2/2020).

Stop using the affected product immediately if it matches the identified lot numbers and expiration dates.

Contact your healthcare provider or pharmacist for guidance regarding the use of these topical treatments.

Return any unused product to the place of purchase for a refund and contact Sesderma, SL for further instructions.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Dryses Aluminum Chlorohydrate Antiperspirant Solution (3.4 fl. oz)

Model:

NDC 63181-0015-1

UPC Codes:

8470003244268

Lot Numbers:

40444601 (Exp 01/2019)

41414601 (Exp 05/2019)

40024602 (Exp 12/2018)

Product: Salises Facial Moisturizing Acne Treatment Gel (1.7 fl. oz)

Model:

NDC 63181-0016

Lot Numbers:

51004101 (Exp 2/2020)

43394101 (Exp 11/2019)

33444101 (Exp 11/2018)

Product: Repaskin 50 Body Lotion Sunscreen gel cream (6.8 fl oz)

Model:

NDC 63181-0013-1

UPC Codes:

8429979415707

Lot Numbers:

41464901 (Exp 05/17)

Product: Repaskin 30 Body Lotion Sunscreen gel cream (6.8 fl oz)

Model:

NDC 63181-0012-1

UPC Codes:

8429979415691

Lot Numbers:

41274901 (Exp 2/19)

Product: Dryses Aluminum Chlorohydrate Deodorant for Men Roll-on (2.5 fl oz)

Model:

NDC 63181-0019-1

UPC Codes:

8470002075221

Lot Numbers:

40414701 (Exp 09/19)

33524701 (Exp 10/18)

40144101 (Exp 10/18)

Product: Dryses Aluminum Chlorohydrate Deodorant for Women Roll-on (2.5 fl oz)

Model:

NDC 16047-0029-1

Lot Numbers:

33454701 (Exp 11/18)

40424701 (Exp 1/2019)

Product: Repaskin 50 Facial Sunscreen gel cream (1.7 fl oz)

Model:

NDC 63181-0011-1

Lot Numbers:

51594901 (Exp 06/18)

Product: Repaskin 30 Facial Sunscreen gel cream (1.7 fl oz)

Model:

NDC 63181-0010-1

Lot Numbers:

51064901 (Exp 07/17)

51064902 (Exp 04/18)

Product: Screenses Color Sunscreen Tinted compact Brown (0.35 oz)

UPC Codes:

8429979252166

Lot Numbers:

H-04 (Exp 07/2019)

Product: Screenses Color Sunscreen Tinted compact Light (0.35 oz)

UPC Codes:

8429979252159

Lot Numbers:

H04.2 (Exp 11/2019)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 73574

Status: Active

Manufacturer: Sesderma, SL

Sold By: specialty retailers

Manufactured In: Spain

Units Affected: 10 products (542 bottles; 459 bottles; 15 bottles; 20 bottles; 354 bottles; 195 bottles; 66 bottles; 27 bottles; 45 compacts; 44 compacts)

Distributed To: Florida, Puerto Rico, Colorado, Georgia