FDA Label for Zinc Oxide
View Indications, Usage & Precautions
Zinc Oxide Product Label
The following document was submitted to the FDA by the labeler of this product Oxygen Development Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Active Ingredient
Titanium Dioxide 4.55%
Zinc Oxide 3.5%
Purpose
Sunscreen
Uses
Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early aging caused by the sun.
Warnings
For external use only. Stop use and ask a doctor if rash occurs. Do not use on damage or broken skin.
When Using
When using this product keep out of eyes. Rinse with water to remove.
Keep Out Of The Reach Of Children.
If swallowed, get medical help or contact a Poison Control center right away.
Directions
Shake before 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 the 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. - 2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
Other Information
Protect the product in this container from excessive heat and direct sunlight.
You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222
Inactive Ingredient
Cyclopentasiloxane, Isododecane, Polysilicone-11, Polymethylsilsesquioxane, Hexyl Laurate, PEG-10 Dimethicone, Polyglyceryl-4 Isostearate, Stearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Alumina, Triethoxycaprylylsilane, Dipalmitoyl Hydroxyproline, Diamond Powder
Package Label.Principal Display Panel
Secondary Package
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