TIZO EYE RENEWAL SPF 20 (NON-TINTED)- zinc oxide cream

TiZO Eye Renewal SPF 20 (Non-Tinted) by

Drug Labeling and Warnings

TiZO Eye Renewal SPF 20 (Non-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 Ingredient:

Zinc Oxide 9%

Purpose:

Sunscreen

Directions:

Apply liberally 15 minutes before sun exposure.

Warning:

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

Warning and Directions:

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

INACTIVE INGREDIENT

Butylene Glycol, Caffeine, Carbomer, Caprylhydroxamic Acid, Caprylyl Glycol, Corallina Officinalis Extract, Cyclohexasiloxane, Cyclopentasiloxane, Dimethicone Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Glycerin, Hydrogen Dimethicone, Isododecane, Isohexadecane, Lauryl PEG/PPG-18/18 Methicone, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20, Saccharomyces/Selenium Ferment, Sambucus Nigra Flower Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undaria Pinnatifida Extract, Water

Warning:

Keep out of the reach of children.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TIZO EYE RENEWAL SPF 20 (NON-TINTED) 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	90 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
SAMBUCUS NIGRA FLOWER (UNII: 07V4DX094T)
DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)
GLYCERIN (UNII: PDC6A3C0OX)
ISOHEXADECANE (UNII: 918X1OUF1E)
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)
SILANETRIOL (UNII: E52D0J3TS5)
LAURYL PEG/PPG-18/18 METHICONE (UNII: ZJ5S27D9NX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CORALLINA OFFICINALIS (UNII: 4004498D06)
DIMETHICONE CROSSPOLYMER (UNII: UF7620L1W6)
WATER (UNII: 059QF0KO0R)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
HYDROGEN DIMETHICONE (20 CST) (UNII: 12Z59IF64N)
ISODODECANE (UNII: A8289P68Y2)
CYCLOHEXASILOXANE (UNII: XHK3U310BA)
CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)
CARBOMER (UNII: 0A5MM307FC)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CAFFEINE (UNII: 3G6A5W338E)
UNDARIA PINNATIFIDA (UNII: ICV1OK7M1S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-113-05	1.5 g in 1 PACKET; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2020

Labeler - Fallien Cosmeceuticals, LTD (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Fragrance Manufacturing Inc.		793406000	manufacture(58892-113)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	analysis(58892-113)