Active Ingredients
Titanium Dioxide 8.6%
Zinc Oxide 10.0%
Powder
FDA Label NDC 61354-043
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oxygen Development Llc for the product Powder (NDC 61354-043). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, stop use, when using, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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 skin aging caused by the sun.
Warnings
For external use only
Stop Use
Stop use and ask doctor if rash occurs
When Using
When using this product keep out of eyes. Rinse with water to remove.
Keep Out Of Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Apply liberally 15 minutes before sun exposure.
Use a water resistant sunscreen if swimming or sweating.
Reapply at least every 2 hours.
Children unther 6 months: Ask a doctor.
Optional: apply to all skin exposed to the sun.
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer 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 - 2p.m.
Wear long - sleeved shirts, pants, hats and sunglasses.
Other Information
Protect the prodcut in this container from excessive heat and direct sunlight.
You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, PO. Box 22, Plainsboro, New Jersey 08536-0222
Package
61354-043-01_aw (Art Pp04911)
61354-043-02_aw (Art Sp11095)
* Please review the disclaimer below.
