BLUE MONARCH Tinted SPF-50 (Rose Gold)

BLUE MONARCH Tinted SPF-50 (Rose Gold) is an FDA drug label for the active ingredient ZINC OXIDE manufactured by Blue Monarch, 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 20231111.

Generic: ZINC OXIDE

Manufacturer: Blue Monarch, LLC

Product Type: HUMAN OTC DRUG

Route: TOPICAL

Dosage Form:

NDC: 72101-419

Application: M020

Effective: 20231111

Active Ingredients: Active Ingredients Zinc Oxide 18.00% Purpose Sunscreen

Indications & Usage

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection 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 and as needed. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours Use a water-resistant sunscreen if swimming or sweating Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Sun Protection Measures. Limit time in the sun, especially from 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses.

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 a doctor if rash or irritation developsand Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use

Adverse Reactions

Not available.

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