14% Zinc Oxide

FDA Drug Profile — Resource Essentials Sun Protection Mineral SPF 30

Drug Details

Generic Name
14% Zinc Oxide
Brand Names
Resource Essentials Sun Protection Mineral SPF 30
Application Number
M020
Sponsor
Skinresource.md, L.L.C.
NDC Codes
1
Dosage Forms
SPRAY
Routes
TOPICAL
Active Ingredients
ZINC OXIDE

Indications and Usage

Uses • Helps prevent sunburn • If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun. Warnings • For external use only Flammable Do not spray near heat, sparks, sources of ignition, or flames. Protect this product from excessive heat and direct sun 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 skin irritation or redness occurs for more than 72 hours. Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away Directions • Apply liberally 15 minutes before sun exposure. Reapply: Every 2 hours during the day after swimming or sweating. • Children under 6 months: ask a doctor. Sun Protection Measure: 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 a.m.to 2 p.m. Wear long-sleeved shirts, pants, hats, and sun glasses

Warnings

Warnings • For external use only - Flammable Do not spray near heat, sparks, sources of ignition, or flames. Protect this product from excessive heat and direct sun 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 skin irritation or redness occurs for more than 72 hours. Keep out of reach of children lf product is swallowed, get medical help or contact a Poison Control Center right away Warnings