Mineral sunscreen

MINERAL SUNSCREEN CUTANEOUS HUMAN OTC DRUG

Mineral sunscreen is an FDA drug label for the active ingredient MINERAL SUNSCREEN manufactured by Guangzhou Origin Beauty Cosmetics Co., Ltd. administered by CUTANEOUS. 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 20260819.

Generic name
MINERAL SUNSCREEN
Manufacturer
Guangzhou Origin Beauty Cosmetics Co., Ltd.
Product type
HUMAN OTC DRUG
Route
CUTANEOUS
Dosage form
N/A
NDC
87545-002
Application
M020
Label effective
20260819

About this product

Mineral sunscreen is an FDA-registered drug product whose active ingredient is MINERAL SUNSCREEN. It is labelled by Guangzhou Origin Beauty Cosmetics Co., Ltd. taken by cutaneous and marketed as a human otc drug product. Identifiers on file: NDC 87545-002, application M020, label effective 20260819. It is one of 4 FDA drug label records sharing the active ingredient MINERAL SUNSCREEN. 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 MINERAL SUNSCREEN are most often described in connection with: helps prevent, sunburn usedas, sunprotection measures, seedirections decreases, riskof skin, early skinaging. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

ZINC OXIDE [NON-NANO] ZINC OXIDE [NON-NANO]

Indications & Usage

Helps prevent sunburn. If usedas directed with other sunprotection measures (seeDirections), decreases the riskof skin cancer and early skinaging caused by the sun, Uses SECTION

Dosage & Administration

Apply liberally 15 minutes before sun exposure Reapply: After 40 minutes of swimming or sweating ■Immediately after towel drying ■At least every 2 hours

Warnings

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

More products with the same ingredient

MINERAL SUNSCREEN

BABIES KIDSSUN PROTECTION

PANERGYTEK USA INC View label

Mineral Sunscreen SPF 50

ALAINA HEALTHCARE PRIVATE LIMITED View label

doTERRA Sun Body

doTERRA International, LLC View label

How products containing MINERAL SUNSCREEN compare

FDA lists 4 drug label records with MINERAL SUNSCREEN 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
— — ALAINA HEALTHCARE PRIVATE LIMITED 1
— — Guangzhou Origin Beauty Cosmetics Co., Ltd. 1
— — PANERGYTEK USA INC 1
— — doTERRA International, LLC 1
— — — —

Recall and safety notices

5 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-0190-2026 Gabriel Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz, Net 61 g per tube, Dist. By: Gabriel Cosmetics, Inc., Redmond, WA USA 98052, NDC: 35192-044-01, UPC 7 07060 9592 1 CA BOTANA International, Inc. Class II Ongoing 20251203
D-0192-2026 Sugared+Bronzed Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, Net WT 3.3 OZ (93 G) per tube, Dist. By: Sugared+Bronzed, 929 Montana Ave, Santa Monica, CA 90403. NDC: 35192-055-18, UPC 8 50047 92223 6 CA BOTANA International, Inc. Class II Ongoing 20251203
D-0183-2026 Doctor. D. Schwab Mineral Sunscreen SPF 50, Zinc Oxide 21%, 4 oz./ 113.4 g per tube, Manufactured by CA Botana, San Diego, CA 92123. NDC: 35192-042-02 CA BOTANA International, Inc. Class II Ongoing 20251203
D-0193-2026 Elixir by Coco March Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-048-17, UPC 8 10145 82007 0 CA BOTANA International, Inc. Class II Ongoing 20251203
D-0194-2026 Elixir by Coco March Tinted Mineral Sunscreen SPF 50, Zinc Oxide 21%, 2.1 oz (62g) per bottle, Distributed by: VitaTienda Co U.S.A., San Juan, PR 00646. NDC: 35192-050-17, UPC 6 7229 99913 8 CA BOTANA International, Inc. Class II Ongoing 20251203

Frequently asked questions

What is Mineral sunscreen used for?
Helps prevent sunburn. If usedas directed with other sunprotection measures (seeDirections), decreases the riskof skin cancer and early skinaging caused by the sun, Uses SECTION

Who makes Mineral sunscreen?
Guangzhou Origin Beauty Cosmetics Co., Ltd. is the labeler of record for Mineral sunscreen. 4 FDA label records share the active ingredient MINERAL SUNSCREEN, 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 Mineral sunscreen come in?
administered by cutaneous. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is 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 MINERAL SUNSCREEN?
Yes. 4 FDA drug label records list MINERAL SUNSCREEN 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 Mineral sunscreen been recalled?
5 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.