CREAM- titanium dioxide, zinc oxide lotion

Cream by

Drug Labeling and Warnings

Cream 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 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 skin aging caused by the sun.

Warnings

For external use only

Stop use and ask doctor if rash occurs.

Do not use on damaged or broken skin.

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 of 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 our 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:

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, NJ 08536-0222.

Inactive Ingredients

Cyclopentasiloxane, Isododecane, Mica, 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, Iron Oxides.

Primary Package (Inner)

61354-051-24

Secondary Package (Outer)

30ml, 61354-051-24

INGREDIENTS AND APPEARANCE

CREAM 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61354-051
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	3.5 mg  in 100 mg
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.55 mg  in 100 mg

Inactive Ingredients
Ingredient Name	Strength
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISODODECANE (UNII: A8289P68Y2)
MICA (UNII: V8A1AW0880)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61354-051-24	1 in 1 CARTON	02/22/2021
1		30 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	part352	02/22/2021

Labeler - OXYGEN DEVELOPMENT, LLC (137098492)

Establishment
Name	Address	ID/FEI	Business Operations
OXYGEN DEVELOPMENT, LLC		137098492	manufacture(61354-051)