TIZO ULTRA ZINC SPF 40 (TINTED)- zinc oxide cream

TiZO Ultra Zinc SPF 40 (Tinted) by

Drug Labeling and Warnings

TiZO Ultra Zinc SPF 40 (Tinted) by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD., Fragrance Manufacturing Inc., Custom Analytics LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients:

Zinc Oxide 20%

Purpose:

Sunscreen

Directions:

Apply liberally 15 minutes before sun exposure.

Warnings:

For external use only. Keep out of the reach of children

Warnings and Directions:

For external use only. Keep out of the reach of children. Apply liberally 15 minutes before sun exposure.

INACTIVE INGREDIENT

Bismuth Oxychloride, C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Hydrogen Dimethicone, Iron Oxides, Mica, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Warning:

Keep out of the reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIZO ULTRA ZINC SPF 40 (TINTED) 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-319
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHANOLAMINE (UNII: 9O3K93S3TK)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) (UNII: 8INO2K35FA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
MICA (UNII: V8A1AW0880)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
IRON OXIDES (UNII: 1K09F3G675)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
WATER (UNII: 059QF0KO0R)
STEARYL DIMETHICONE (400 MPA.S AT 50C) (UNII: R327X197HY)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-319-05	5 g in 1 TUBE; Type 0: Not a Combination Product	03/15/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/15/2022

Labeler - Fallien Cosmeceuticals, LTD. (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(58892-319)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-319)