Zinc Oxide by Oxygen Development LLC ZINC OXIDE- cream cream

Zinc Oxide by

Drug Labeling and Warnings

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

Drug Details [pdf]

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

PRINCIPAL DISPLAY PANEL

Secondary package

INGREDIENTS AND APPEARANCE

ZINC OXIDE 
cream cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-097
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.54 mg  in 100 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.498 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
ISODODECANE (UNII: A8289P68Y2)	10.69 mg  in 100 mg
HEXYL LAURATE (UNII: 4CG9F9W01Q)	1.76 mg  in 100 mg
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)	4.68 mg  in 100 mg
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)	3.19 mg  in 100 mg
PEG-10 DIMETHICONE (220 CST) (UNII: 287GF3Y3WC)	1.65 mg  in 100 mg
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)	55.74 mg  in 100 mg
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)	1.5 mg  in 100 mg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-097-01	1 in 1 CARTON	06/23/2023
1		100 mg in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	06/23/2023

Labeler - Oxygen Development LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
Oxygen Development LLC		137098492	manufacture(61354-097)