bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01

TITANIUM DIOXIDE TOPICAL HUMAN OTC DRUG

bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01 is an FDA drug label for the active ingredient TITANIUM DIOXIDE manufactured by Orveon Global US, LLC 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 20231004.

Generic name
TITANIUM DIOXIDE
Manufacturer
Orveon Global US, LLC
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
98132-751
Application
M020
Label effective
20231004

About this product

bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01 is an FDA-registered drug product whose active ingredient is TITANIUM DIOXIDE. It is labelled by Orveon Global US, LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 98132-751, application M020, label effective 20231004. It is one of 71 FDA drug label records sharing the active ingredient TITANIUM DIOXIDE. 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 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 ingredient(s) Titanium dioxide 6.2%

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 For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours children under 6 months: 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 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-sleeve shirts, pants, hats, and sunglasses

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 ask a doctor if rash occurs Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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TITANIUM DIOXIDE

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How products containing TITANIUM DIOXIDE compare

FDA lists 71 drug label records with TITANIUM DIOXIDE 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
— — Amway Corp 16
— — Farmasi US LLC 12
— — Orveon Global US LLC 7
— — TAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI 4
— — 3LAB, Inc 3

Frequently asked questions

What is bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01 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 bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01?
Orveon Global US, LLC is the labeler of record for bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01. 71 FDA label records share the active ingredient TITANIUM DIOXIDE, 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 bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01 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 bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01 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?
Yes. 71 FDA drug label records list TITANIUM DIOXIDE 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 bareMinerals Complexion Rescue Broad Spectrum SPF 30 Opal 01 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.