Checked
OTC
208
zinc oxide · 208 is an over-the-counter drug containing zinc oxide, made by PETER L. KOPELSON, M.D.,.
- Type
- Over the counter
- Drug class
- Not classified
- Route
- Topical
- Manufacturers
- 1
- + 2 repackager labels
Related recalls
FDA drug recalls that name this drug or its active ingredient
- Class IIDrugOngoing12/10/2025Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw...Blossom Pharmaceuticals · 7 products · cGMP deviations
- Class IIDrugOngoing12/03/2025Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA...CA BOTANA International, Inc. · 8 products · CGMP Deviations
- Class IIDrugOngoing11/26/2025Renew PeriProtect, Zinc Oxide 12%, Dimethicone 1%, 113g (4 oz.) per tube, DermaRite Industries LLC, 7777...DermaRite Industries, LLC · CGMP Deviation; manufactured at the same facility where other...
- Class IIDrugOngoing09/17/2025Ultra Violette, Velvet Screen SPF 50, Blurring Mineral Skinscreen, Zinc Oxide 22.75%, a) 15 mL, 0.5 fl....GRACE & FIRE PTY LTD · 2 products · Subpotent/Super-potent Product: Testing of the SPF 50 sunscreen...
- Class IIDrugOngoing07/16/2025B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint...KABANA SKIN CARE · 4 products · cGMP deviations
Forms and strengths
From the FDA NDC Directory · 1 product codes
| Dosage form | Strength | Route | NDCs |
|---|---|---|---|
| Cream | 160 mg/g | topical | 1 |
Manufacturers and labels
2 FDA labels · 2 from repackagers
Repackager labels (2)
- PETER L. KOPELSON, M.D.,12/11/2025
- PETER L. KOPELSON, M.D.12/11/2025
208: common questions
- Is 208 a prescription drug?
- No. 208 is sold over the counter (OTC) without a prescription.
- Are there other products with the same active ingredient as 208?
- Yes. Other FDA-listed products with the same active ingredients include Diaper Rash, Zinc Oxide 20%, SPF 50 Sunscreen Stick, Cream.
- Who makes 208?
- PETER L. KOPELSON, M.D., lists 208 with the FDA.
Source: U.S. Food and Drug Administration, openFDA drug label (SPL) and NDC Directory · Last updated 12/11/2025 · Label text is shown as published by the manufacturer. Not medical advice
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