Zinc Oxide Perfecting Sunscreen

ZINC OXIDE TOPICAL HUMAN OTC DRUG

Zinc Oxide Perfecting Sunscreen is an FDA drug label for the active ingredient ZINC OXIDE manufactured by Epicuren Discovery 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 20260714.

Generic name
ZINC OXIDE
Manufacturer
Epicuren Discovery
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
84378-100
Application
M020
Label effective
20260714

About this product

Zinc Oxide Perfecting Sunscreen is an FDA-registered drug product whose active ingredient is ZINC OXIDE. It is labelled by Epicuren Discovery taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 84378-100, application M020, label effective 20260714. 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.

Active ingredients

Active Ingredients

Indications & Usage

Indication and Use

Dosage & Administration

Dosage and Administration

Warnings

Other information

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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 Zinc Oxide Perfecting Sunscreen used for?
Indication and Use

Who makes Zinc Oxide Perfecting Sunscreen?
Epicuren Discovery is the labeler of record for Zinc Oxide Perfecting 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 Zinc Oxide Perfecting 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 Zinc Oxide Perfecting 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 Zinc Oxide Perfecting 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.