ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)

TITANIUM DIOXIDE, ZINC OXIDE TOPICAL HUMAN OTC DRUG

ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan) is an FDA drug label for the active ingredient TITANIUM DIOXIDE, ZINC OXIDE manufactured by ZO Skin Health 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 20260416.

Generic name
TITANIUM DIOXIDE, ZINC OXIDE
Manufacturer
ZO Skin Health Inc.
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
42851-205
Application
M020
Label effective
20260416

About this product

ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan) is an FDA-registered drug product whose active ingredient is TITANIUM DIOXIDE, ZINC OXIDE. It is labelled by ZO Skin Health Inc. taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 42851-205, application M020, label effective 20260416. It is one of 84 FDA drug label records sharing the active ingredient TITANIUM DIOXIDE, 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 TITANIUM DIOXIDE, ZINC OXIDE are most often described in connection with: helps prevent, sunburn higher, spf gives, protection provides, 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

Drug Facts Active Ingredients Titanium Dioxide 5.4% Zinc Oxide 13.2%

Indications & Usage

Uses ■ helps prevent sunburn ■ higher SPF gives more sunburn protection ■ provides high protection against 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 and as needed. ■ Use a water-resistant sunscreen if swimming or sweating ■ Reapply: ■ 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

Warnings

For external use only.

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TITANIUM DIOXIDE, ZINC OXIDE

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Anhydrous SPF 30

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How products containing TITANIUM DIOXIDE, ZINC OXIDE compare

FDA lists 84 drug label records with TITANIUM DIOXIDE, 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
— — Elements Brands, Inc. 6
— — Drmtlgy, LLC 4
— — ENGLEWOOD LAB, INC. 4
— — Boscia LLC 3
— — UNDRBUDR, LLC 3

Frequently asked questions

What is ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan) used for?
Uses ■ helps prevent sunburn ■ higher SPF gives more sunburn protection ■ provides high protection against 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 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan)?
ZO Skin Health Inc. is the labeler of record for ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan). 84 FDA label records share the active ingredient TITANIUM DIOXIDE, 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 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan) 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 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan) 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 TITANIUM DIOXIDE, ZINC OXIDE?
Yes. 84 FDA drug label records list TITANIUM DIOXIDE, 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 ZO Skin Health Daily Mineral Sunshade Broad-Spectrum Sunscreen SPF 45 (Tan) 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.