Sonage Protec Plus SPF 30 Mineral Sunscreen

ZINC OXIDE TOPICAL HUMAN OTC DRUG

Sonage Protec Plus SPF 30 Mineral Sunscreen is an FDA drug label for the active ingredient ZINC OXIDE manufactured by ASA Universal Inc. dba: Sonage 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 20260812.

Generic name
ZINC OXIDE
Manufacturer
ASA Universal Inc. dba: Sonage
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
69546-322
Application
M020
Label effective
20260812

About this product

Sonage Protec Plus SPF 30 Mineral Sunscreen is an FDA-registered drug product whose active ingredient is ZINC OXIDE. It is labelled by ASA Universal Inc. dba: Sonage taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 69546-322, application M020, label effective 20260812. It is one of 404 FDA drug label records sharing the active ingredient 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 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

Active Ingredient: Zinc Oxide 15.7%

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. • Reapply after 80 minutes of swimming or sweating • Reapply immediately after towel drying • Reapply at least every 2 hours. • Children under 6 months: Ask 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses.

Warnings

Warnings: For external use only Do not use on damaged or broken skin. When using this product keep out of eye. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If the product is swallowed, get medical help or contact a Poison Control Center right away.

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How products containing ZINC OXIDE compare

FDA lists 404 drug label records with 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 formProductsManufacturerProducts
— — Ilia, Inc. 30
— — COSMAX USA, CORP 24
— — Colorescience 16
— — Allure Labs Inc 9
— — Raw Elements LLC 9

Frequently asked questions

What is Sonage Protec Plus SPF 30 Mineral Sunscreen 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 Sonage Protec Plus SPF 30 Mineral Sunscreen?
ASA Universal Inc. dba: Sonage is the labeler of record for Sonage Protec Plus SPF 30 Mineral Sunscreen. 404 FDA label records share the active ingredient 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 Sonage Protec Plus SPF 30 Mineral Sunscreen 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 Sonage Protec Plus SPF 30 Mineral Sunscreen 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 ZINC OXIDE?
Yes. 404 FDA drug label records list 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 Sonage Protec Plus SPF 30 Mineral Sunscreen 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.