Coola Bare Republic Mineral Face-Lotion SPF 70
Coola Bare Republic Mineral Face-Lotion SPF 70 is an FDA drug label for the active ingredient TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8% manufactured by COOLA 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 20231220.
- Generic name
- TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%
- Manufacturer
- COOLA LLC
- Product type
- HUMAN OTC DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 79753-041
- Application
- M020
- Label effective
- 20231220
About this product
Coola Bare Republic Mineral Face-Lotion SPF 70 is an FDA-registered drug product whose active ingredient is TITANIUM DIOXIDE 3.5% ZINC OXIDE 15.8%. It is labelled by COOLA LLC taken by topical and marketed as a human otc drug product. Identifiers on file: NDC 79753-041, application M020, label effective 20231220. 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 3.5% ZINC OXIDE 15.8% 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
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 ● 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 ●Children under 6 months: Ask a doctor
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 doctor if skin rash occurs
Frequently asked questions
What is Coola Bare Republic Mineral Face-Lotion SPF 70 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 Coola Bare Republic Mineral Face-Lotion SPF 70?
COOLA LLC is the labeler of record for Coola Bare Republic Mineral Face-Lotion SPF 70.
What form does Coola Bare Republic Mineral Face-Lotion SPF 70 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 Coola Bare Republic Mineral Face-Lotion SPF 70 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.
Has Coola Bare Republic Mineral Face-Lotion SPF 70 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.