Antioxidant Sunscreen SPF 40
Antioxidant Sunscreen SPF 40 is an FDA drug label for the active ingredient OCTINOXATE AND ZINC OXIDE manufactured by Topiderm, Inc. 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 20191113.
- Generic name
- OCTINOXATE AND ZINC OXIDE
- Manufacturer
- Topiderm, Inc.
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 51326-829
- Application
- M020
- Label effective
- 20191113
About this product
Antioxidant Sunscreen SPF 40 is an FDA-registered drug product whose active ingredient is OCTINOXATE AND ZINC OXIDE. It is labelled by Topiderm, Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 51326-829, application M020, label effective 20191113. It is one of 4 FDA drug label records sharing the active ingredient OCTINOXATE AND ZINC OXIDE. 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 OCTINOXATE AND ZINC OXIDE 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 liberally 15 minutes before sun exposure Re-apply after 80 minutes of swimming or sweating, anytime after towel drying, or at least every 2 hours Use a water resistant sunscreen if swimming or sweating Use on children under 6 months of age: consult a doctor. 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 of 15 or higher and other sunscreen measures including: limit time in the sun, especially from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses
Warnings
Warnings For external use only. When using this product keep out of eyes, rinse with water to remove. Stop use if signs of irritation or rash appear.If irritation or rash persists consult a doctor. Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
More products with the same ingredient
OCTINOXATE AND ZINC OXIDECeraVe Developed with Dermatologists Skin Renewing Broad Spectrum SPF 30 Day
View labelOlay Complete Lightweight with Sunscreen Broad Spectrum SPF 15 Sensitive
View labelReactive Plus Anti-Oxidant Serum plus Broad-spectrum SPF 45
View labelHow products containing OCTINOXATE AND ZINC OXIDE compare
FDA lists 4 drug label records with OCTINOXATE AND ZINC OXIDE as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.
| Dosage form | Products | Manufacturer | Products |
|---|---|---|---|
| — | — | L'Oreal USA Products Inc. | 1 |
| — | — | Merz North America, Inc | 1 |
| — | — | The Procter & Gamble Manufacturing Company | 1 |
| — | — | Topiderm, Inc. | 1 |
| — | — | — | — |
Frequently asked questions
What is Antioxidant Sunscreen SPF 40 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 Antioxidant Sunscreen SPF 40?
Topiderm, Inc. is the labeler of record for Antioxidant Sunscreen SPF 40. 4 FDA label records share the active ingredient OCTINOXATE AND ZINC OXIDE, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.
What form does Antioxidant Sunscreen SPF 40 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 Antioxidant Sunscreen SPF 40 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.
Are there other products containing OCTINOXATE AND ZINC OXIDE?
Yes. 4 FDA drug label records list OCTINOXATE AND ZINC OXIDE as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.
Has Antioxidant Sunscreen SPF 40 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.