Active Ingredient
Titanium Dioxide 15%
Zinc oxide 17%
Powder
FDA Label NDC 61354-061
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 61354-061). 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 ingredient, purpose, uses, warnings, do not use, when using, stop use, 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
Help precent 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
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.
Stop Use
Stop use and ask a doctor if rash occurs
Keep Out Of The Reach Of Children
If swallowed, get medical help or contact a poison controler center right away
Directions
Apply generously 15 minutes before sun exposure. Children under 6 months of age: ask a doctor.
Reapply: immediately after towel drying. At least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Sun protections measures. 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: lomit 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 sun
Iniactive Ingredient
pollymethylsilsesquoxane, silica, jojoba esters, alumina, oryza sativa (rice)extract, caprylyl glycol, phenoxyethanol, hexylene glycol, aluminum dimyristate, triethoxycaprylylsilane, disodium stearoyl glutamate, iron oxides, mica.
Questions Or Comments
(844) 821 8151
Pimary Package
61354-061-01_aw (Art 050 Lbl Wrp 063)
Secondary Package
61354-061-01_aw (Art 050 Uni 863)
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