Zinc Oxide 20.00%
Zinc Oxide 20.00% is an FDA drug label for the active ingredient SPF 50 MINERAL manufactured by Coconut Caliente Costa Rica LLC 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 20260507.
- Generic name
- SPF 50 MINERAL
- Manufacturer
- Coconut Caliente Costa Rica LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 85033-001
- Application
- M020
- Label effective
- 20260507
About this product
Zinc Oxide 20.00% is an FDA-registered drug product whose active ingredient is SPF 50 MINERAL. It is labelled by Coconut Caliente Costa Rica LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 85033-001, application M020, label effective 20260507. 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 SPF 50 MINERAL are most often described in connection with: helps prevent. 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
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.
Frequently asked questions
What is Zinc Oxide 20.00% used for?
Uses Helps prevent sunburn
Who makes Zinc Oxide 20.00%?
Coconut Caliente Costa Rica LLC is the labeler of record for Zinc Oxide 20.00%.
What form does Zinc Oxide 20.00% 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 20.00% 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 20.00% been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.
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.