FDA Recalls Mineral Sunscreen Due to Manufacturing Process Deviations
CA BOTANA International is recalling Elixir by Coco March Mineral Sunscreen SPF 50 due to Current Good Manufacturing Practice (CGMP) deviations. The recall affects 3,295 bottles distributed in CA, CO, FL, PR, and WA.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall of a topical sunscreen due to manufacturing process deviations, with no reported illnesses or injuries. The specific nature of the CGMP violation is not disclosed, and no consumer harm has been documented.
Plain-English summary
CA BOTANA International is recalling Elixir by Coco March Mineral Sunscreen SPF 50 (NDC 35192-048-17) in 2.1 oz bottles. The affected lot is D53682, with an expiration date of March 31, 2027. A total of 3,295 bottles have been distributed.
The sunscreen is being recalled due to Current Good Manufacturing Practice (CGMP) deviations. The product was distributed to California, Colorado, Florida, Puerto Rico, and Washington. The recall was initiated by the manufacturer on October 10, 2025, and is voluntary.
Consumers who have purchased this product should discontinue use. Contact CA BOTANA International or the distributor VitaTienda Co U.S.A. for instructions on returns or refunds. The FDA is monitoring the recall on an ongoing basis.
The recalled product
- Product
- Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0
- Manufacturer
- CA BOTANA International, Inc.
- Category
- Drug — Sunscreen
- Hazard
- manufacturing-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot D53682
- exp 3/31/2027
Distribution
Distributed in 5 states:
- CA
- CO
- FL
- PR
- WA
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