SOOTHE Daily Mineral Sunscreen

TITANIUM DIOXIDE, ZINC OXIDE TOPICAL HUMAN OTC DRUG

SOOTHE Daily Mineral Sunscreen is an FDA drug label for the active ingredient TITANIUM DIOXIDE, ZINC OXIDE manufactured by Rodan & Fields 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 20231130.

Generic name
TITANIUM DIOXIDE, ZINC OXIDE
Manufacturer
Rodan & Fields
Product type
HUMAN OTC DRUG
Route
TOPICAL
Dosage form
N/A
NDC
14222-2440
Application
M020
Label effective
20231130

Active ingredients

Active Ingredients Titanium Dioxide 3.6% Zinc Oxide 2.34%

Indications & Usage

Uses Helps prevent sunburn. When 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 before use. Every AM, apply liberally and evenly over face + neck 15 minutes before sun exposure. Reapply at least every 2 hours. Reapply after 40 minutes of swimming or sweating and after 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 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 AM - 2 PM. Wear long-sleeve shirts, pants, hats and sunglasses. Children under 6 months: Ask a doctor.

Contraindications

Not available.

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

Adverse Reactions

Not available.

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