Zinc Oxide 20%
Zinc Oxide 20% is an FDA drug label for the active ingredient SUNSCREEN SPF 50 manufactured by The Beach Rooster administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20260701.
- Generic name
- SUNSCREEN SPF 50
- Manufacturer
- The Beach Rooster
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 87223-001
- Application
- M020
- Label effective
- 20260701
About this product
Zinc Oxide 20% is an FDA-registered drug product whose active ingredient is SUNSCREEN SPF 50. It is labelled by The Beach Rooster taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 87223-001, application M020, label effective 20260701. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.
What it is used for
Across FDA labelling, products containing SUNSCREEN SPF 50 are most often described in connection with: helps prevent, sun protection, measures see, directions decreases, risk skin, aging caused. Wording differs between labels, and the full indications section on this page takes precedence when it is present.
Active ingredients
Indications & Usage
Uses Helps prevent sunburn . If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Dosage & Administration
Directions Apply evenly to face and neck 15 minutes before sun exposure reapply: After 80 minutes of swimming or sweating . Immediately after towel drying . At least every 2 hours • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10a.m.– 2p.m. . Wear long-sleeve shirts, pants, hats, and sunglasses. . Children under 6 months: Ask a doctor.
Warnings
Warnings For external use only. Do not use on damaged or broken skin. When using this product • keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs.
Recall and safety notices
3 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.
| Recall | Product | Firm | Class | Status | Reported |
|---|---|---|---|---|---|
| D-0212-2026 | Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02. | Blossom Pharmaceuticals | Class II | Ongoing | 20251210 |
| D-0206-2026 | Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15. | Blossom Pharmaceuticals | Class II | Ongoing | 20251210 |
| D-0298-2025 | babyganics, Sheer Blend, SPF 50 Mineral Sunscreen Fragrance Free (zinc oxide 20%), a) 1.7 FL OZ (50 mL) bottle, UPC 810035921658, b) 8 FL OZ (236 mL) bottle, UPC 810035921382, Dist. by KAS Direct, LLC, 1525 Howe St., Racine, WI 53403, Made in Canada. | Johnson, S C and Son, Inc | Class II | Ongoing | 20250402 |
Frequently asked questions
What is Zinc Oxide 20% used for?
Uses Helps prevent sunburn . If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Who makes Zinc Oxide 20%?
The Beach Rooster is the labeler of record for Zinc Oxide 20%.
What form does Zinc Oxide 20% come in?
administered by topical. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.
Is Zinc Oxide 20% prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.
Has Zinc Oxide 20% been recalled?
3 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.
Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.
This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.