Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50

ZINC OXIDE TOPICAL HUMAN OTC DRUG

Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 is an FDA drug label for the active ingredient ZINC OXIDE manufactured by Galderma Laboratories, L.P. 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 20231114.

Generic name
ZINC OXIDE
Manufacturer
Galderma Laboratories, L.P.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
0299-4110
Application
M020
Label effective
20231114

About this product

Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 is an FDA-registered drug product whose active ingredient is ZINC OXIDE. It is labelled by Galderma Laboratories, L.P. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 0299-4110, application M020, label effective 20231114. 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 Ingredients Zinc Oxide 12%

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 shake well apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age: 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. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses Other Information ▪ protect the product in this container from excessive heat and direct sun

Warnings

Warnings For external use only

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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

Recall and safety notices

2 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.

RecallProductFirmClassStatusReported
D-1031-2016 Doxycycline, USP Capsules 40 mg, Packaged in 30 ct Bottles, Rx Only. Marketed by: Prasco Laboratories, Mason, OH 45040 USA, Manufactured by: Catalent Pharma Solutions, LLC, Winchester, Kentucky 40391. NDC: 66993-815-30. Galderma Laboratories, L.P. Class III Terminated 20160622
D-1660-2012 Capex Shampoo (fluocinolone acetonide), Topical Shampoo, 0.01%, Rx only, For Topical Use Only, 4 fl oz in a 6 oz bottle, Marketed by: Galderma Laboratories, LP, Fort Worth, TX, Mfd. by: Hill Dermaceuticals, Inc., Sanford, FL --- NDC 0299-5500-04, Galderma Laboratories, L.P. Class III Terminated 20120905

Frequently asked questions

What is Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 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 Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50?
Galderma Laboratories, L.P. is the labeler of record for Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50. 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 Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 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 Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 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 Cetaphil Sheer Mineral Face Liquid Sunscreen SPF 50 been recalled?
2 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.