CLASS II ONGOING Drug recall · Reported 3 Dec 2025 · FDA Enforcement Report
Elixir by Coco March Tinted Mineral Sunscreen SPF recalled
CA BOTANA International is recalling Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21% per, distributed in California, Colorado, Florida, Puerto Rico, Washington. The recall was initiated on 10 Oct 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0194-2026
- FDA event ID
- 97820
- Recalling firm
- CA BOTANA International, San Diego, CA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 10 Oct 2025
- FDA classified
- 26 Nov 2025
- Reported
- 3 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Sunscreen & Personal Care
Timeline
| 10 Oct 2025 | Recall initiated by company | |
| 26 Nov 2025 | Classified by FDA | +47 days |
| 3 Dec 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Elixir by Coco March Tinted 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: 35192-050-17, UPC 6 7229 99913 8
Where it was distributed
CA, CO, FL, PR, WA
Questions about this recall
Is Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21% per recalled?
Yes. CA BOTANA International recalled Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21% per on 10 Oct 2025. The recall is Class II and its status is Ongoing. Recall number D-0194-2026.
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot D53681, exp 03/31/2027
Where was it sold?
CA, CO, FL, PR, WA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.