POWDER- zinc oxide powder

Powder by

Drug Labeling and Warnings

Powder by is a Otc medication manufactured, distributed, or labeled by Oxygen Development LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Titanium Dioxide 8.6%

Zinc Oxide 10.0%

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

Package

INGREDIENTS AND APPEARANCE

POWDER 
zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-043
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	8.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)	73 g  in 100 g
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)	5.35 g  in 100 g
POTASSIUM HYDROLYZED JOJOBA ESTERS (UNII: CH428W5O62)	0.55 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-043-02	1 in 1 CARTON	01/11/2022
1	NDC: 61354-043-01	8 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/11/2022

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-043)