TIZO3- titanium dioxide, zinc oxide cream

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Titanium Dioxide 8%

Zinc Oxide 3.8%

PURPOSE

Sunscreen

INDICATIONS & USAGE

Helps prevent sunburn.

WARNINGS

For external use only.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure.

INACTIVE INGREDIENT

Alumina, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Iron Oxide (CI 77491), Lauryl PEG/PPG-18/18 Methicone, Hydrogen Dimethicone, PEG-10 Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIZO3 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-326
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	85.4 mg  in 1 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	40.7 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALUMINA (UNII: LMI26O6933)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
CI 77492 (UNII: EX438O2MRT)
CI 77499 (UNII: XM0M87F357)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
CI 77491 (UNII: 1K09F3G675)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-326-05	5 mL in 1 TUBE; Type 0: Not a Combination Product	05/10/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	05/10/2015

Labeler - Fallien Cosmeceuticals Ltd. (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-326)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(58892-326)