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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Various CA BOTANA Sunscreens and Topical Gels Recalled for Manufacturing Issues

Agency Publication Date: November 26, 2025
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Summary

CA BOTANA International, Inc. has recalled 24,356 units of various sunscreens, pain relief gels, and skin treatments due to Good Manufacturing Practice (CGMP) deviations. The recall includes multiple brands such as CLEARSTEM, Doctor D. Schwab, Gabriel, and Sea Enzyme, which were distributed in five U.S. states and territories. Consumers should check their products for specific brands and lot numbers that do not meet quality standards.

Risk

The recall is due to deviations from current Good Manufacturing Practices, which means the safety, purity, or potency of these topical products cannot be guaranteed. There is a potential risk that the products may be ineffective or contain impurities that could lead to skin irritation or other adverse reactions.

What You Should Do

  1. Check your product packaging for the brand name and the lot number and expiration date printed on the bottle or tube. See the Affected Products section below for the full list of affected codes.
  2. If you have health concerns, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact CA BOTANA International, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: CLEARSTEM YOU ARE SUNSHINE SPF 50 (2.1 oz/61g)by CLEARSTEM Skincare
Variants: Zinc Oxide 21%, Bottle
Lot Numbers:
D54447 (Exp 11/30/2027)
NDC:
35192-046-17
Product: Dr. Bump Natural Pain Relief Gel (4 FL OZ/118 ML)by Dr. Bump
Variants: Menthol 5%, Bottle
UPC Codes:
818204025138
Lot Numbers:
D54947 (Exp 4/30/2028)
NDC:
35192-052-18
Product: Doctor D. Schwab Mineral Sunscreen SPF 50 (4 oz/113.4 g)by Doctor D. Schwab
Variants: Zinc Oxide 21%, Tube
Lot Numbers:
D54596 (Exp 1/31/2028)
NDC:
35192-042-02
Product: Doctor D. Schwab Flawless Skin Fluid Tinted Moisturizer SPF 50 (2.1 oz/61 g)by Doctor D. Schwab
Variants: Zinc Oxide 21%, Tube
Lot Numbers:
D54757 (Exp 3/31/2028)
NDC:
35192-043-17
Product: Doctor D. Schwab Controlling Balm with Tea Tree Oil (1 FL OZ/30 ML)by Doctor D. Schwab
Variants: Salicylic Acid 0.8%, Tube
Lot Numbers:
D54361 (Exp 8/31/2027)
NDC:
35192-016-05
Product: Doctor D. Schwab Controlling Cream (1 FL OZ/30 ML)by Doctor D. Schwab
Variants: Benzoyl Peroxide 2.7%, Tube
Lot Numbers:
D54066 (Exp 5/31/2027)
NDC:
35192-017-05
Product: Sea Enzyme Ultra Umbrella Sunscreen SPF 30 (4 oz/113.4 g)by Sea Enzyme
Variants: Titanium Dioxide 4%, Octinoxate 4%, Tube
Lot Numbers:
D53950 (Exp 5/31/2027)
NDC:
35192-011-02
Product: Doctor D. Schwab Clinical Weh Weh Natural Pain Relief Gel (4.2 oz/120 g)by Doctor D. Schwab
Variants: Menthol 5%, Tube
Lot Numbers:
D53081 (Exp 7/31/2026)
NDC:
35192-020-02
Product: Doctor D. Schwab Shimmery Sun Lotion Sunscreen SPF 30 (4 oz/113.4 g)by Doctor D. Schwab
Variants: Titanium Dioxide 5%, Octinoxate 4%, Tube
Lot Numbers:
D54597 (Exp 1/31/2028)
NDC:
35192-012-02
Product: Gabriel Mineral Sunscreen SPF 50 (2.1 oz/61 g)by Gabriel Cosmetics
Variants: Zinc Oxide 21%, Tube
UPC Codes:
70706095921
Lot Numbers:
D53371 (Exp 10/31/2026)
NDC:
35192-044-01
Product: Karina Daily Moisturizer SPF 25 (5 oz/141.7 g)by Karina
Variants: Octinoxate 7.5%, Zinc Oxide 7.0%, Tube
UPC Codes:
818204025725
Lot Numbers:
D54098 (Exp 3/31/2027)
NDC:
35192-033-16
Product: Sugared+Bronzed Tinted Mineral Sunscreen SPF 50 (3.3 oz/93 g)by Sugared+Bronzed
Variants: Zinc Oxide 21%, Tube
UPC Codes:
850047922236
Lot Numbers:
D53797 (Exp 04/30/2027)
NDC:
35192-055-18
Product: Elixir by Coco March Mineral Sunscreen SPF 50 (2.1 oz/62g)by Elixir by Coco March
Variants: Zinc Oxide 21%, Bottle
UPC Codes:
810145820070
Lot Numbers:
D53682 (Exp 3/31/2027)
NDC:
35192-048-17
Product: Elixir by Coco March Tinted Mineral Sunscreen SPF 50 (2.1 oz/62g)by Elixir by Coco March
Variants: Zinc Oxide 21%, Bottle
UPC Codes:
67229999138
Lot Numbers:
D53681 (Exp 03/31/2027)
NDC:
35192-050-17

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97820
Status: Active
Manufacturer: CA BOTANA International, Inc.
Sold By: CLEARSTEM Skincare; 1Beauty US LLC; Beauty4Pros LLC; Sugared+Bronzed; VitaTienda Co U.S.A.; Gabriel Cosmetics, Inc.
Manufactured In: United States
Units Affected: 13 products (1167 tubes; 1401 tubes; 555 tubes; 470 tubes; 874 tubes; 810 tubes; 805 tubes; 1617 tubes; 1492 tubes; 2090 tubes; 3295 bottles; 4890 bottles; 4890 bottles)
Distributed To: California, Colorado, Florida, Puerto Rico, Washington

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 ยท 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.