koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen

TITANIUM DIOXIDE, ZINC OXIDE TOPICAL HUMAN OTC DRUG

koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen is an FDA drug label for the active ingredient TITANIUM DIOXIDE, ZINC OXIDE manufactured by Kapa'ihi, 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 20231111.

Generic name
TITANIUM DIOXIDE, ZINC OXIDE
Manufacturer
Kapa'ihi, Inc
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
71889-350
Application
M020
Label effective
20231111

About this product

koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen is an FDA-registered drug product whose active ingredient is TITANIUM DIOXIDE, ZINC OXIDE. It is labelled by Kapa'ihi, Inc taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 71889-350, application M020, label effective 20231111. 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, 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 Titanium Dioxide (6.00%) Zinc Oxide (6.00%) Purpose Sunscreen

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 at least every two-hours or immediately after swimming. sweating or towel drying. SUN PROTECTION MEASURES, Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: - Wear long sleeve shirts, pants, hats and sunglasses. - For children under 6-months, consult a physician.

Warnings

WARNINGS: For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and consult physician if irritation or rash develops. Keep out of reach of children. If product is swallowed, get medical attention or contact poison control center immediately

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TITANIUM DIOXIDE, ZINC OXIDE

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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 koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection 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 koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen?
Kapa'ihi, Inc is the labeler of record for koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection Sunscreen. 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 koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection 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 koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection 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 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 koa protect our ocean life OXYBENZONE FREE Broad Spectrum SPF 30 UVA UVB Protection 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.