Active Ingredients
Titanium Dioxide 8.6
zinc Oxide 10.0
Powder
FDA Label NDC 61354-052
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 for the product Powder (NDC 61354-052). 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, do not use, when using, keep out of the reach of children, 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 again caused by the sun.
Warnings
For external use only
Stop Use
Stop use and ask doctor if rash occurs
Do Not Use
Do not use on damaged 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 rigth away
Directions
Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. reapply at lease every 2 hours. Children under 6 months: ask a doctor. optional: apply toall skin exposed to the sun. Sun Protection measures. spending time in the sin increases your risk ofg skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15or 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 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, New Jersey 08536-0222.
Primary Package
61354-052_aw (Art Pp03921 Page 1)
61354-052_aw (Art Pp03921 Page 2)
61354-052_aw (Art Pp03921 Page 3)
Secondary Package
61354-052-01_aw (Art Sp11095)
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