TIZO EYE RENEWAL SPF 20 (NON-TINTED)- zinc oxide cream 
Fallien Cosmeceuticals, LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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DRUG FACTS

Active Ingredients:

Zinc Oxide 9%

Purpose:

Sunscreen

Uses:

Helps prevents 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. Do not use on damaged or broken skin. Stop use and ask a doctor if rash occurs. When using this product, keep out of eyes. Rinse with water to remove. Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions:

Inactive Ingredients:

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 Hydrogen Dimethicone,PaImitoyI Tripeptide-1, PaImitoyl Tetrapeptide-7, PEG-10 Dimethicone, Polysorbate 20, Saccharomy- ces/Selenium Ferment, Sambucus Nigra Flower Extract, Siloxanetriol Alginate, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Undaria Pinnatifida Extract, Water

Other Information:

Principal Display Panel - 100 g Carton Label

MINERAL
PROTECTION

TIZO®

EYE RENEWAL

NON-TINTED
SPF 20

Firming Eye Repair

Mineral Sunscreen

Gentle Zinc Oxide

Peptides

Botanical Blend

Broad Spectrum SPF 20

Net Wt. 0.5 oz/15 g

Principal Display Panel - 100 g Carton Label
TIZO EYE RENEWAL SPF 20 (NON-TINTED) 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide90 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butylene Glycol (UNII: 3XUS85K0RA)  
Caffeine (UNII: 3G6A5W338E)  
Carbomer Homopolymer, Unspecified Type (UNII: 0A5MM307FC)  
Caprylhydroxamic Acid (UNII: UPY805K99W)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Corallina Officinalis (UNII: 4004498D06)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dimethicone Crosspolymer (450000 MPA.S AT 12% in Cyclopentasiloxane) (UNII: UF7620L1W6)  
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
Dimethiconol (2000 CST) (UNII: T74O12AN6Y)  
Glycerin (UNII: PDC6A3C0OX)  
Hydrogen Dimethicone (20 CST) (UNII: 12Z59IF64N)  
Isododecane (UNII: A8289P68Y2)  
Isohexadecane (UNII: 918X1OUF1E)  
Lauryl PEG/PPG-18/18 Methicone (UNII: ZJ5S27D9NX)  
Palmitoyl Tripeptide-1 (UNII: RV743D216M)  
Palmitoyl Tetrapeptide-7 (UNII: Q41S464P1R)  
PEG-10 Dimethicone (600 CST) (UNII: 8PR7V1SVM0)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Saccharomyces Cerevisiae (UNII: 978D8U419H)  
Sambucus Nigra Flower (UNII: 07V4DX094T)  
Silanetriol (UNII: E52D0J3TS5)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Undaria Pinnatifida (UNII: ICV1OK7M1S)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-113-151 in 1 CARTON09/01/2020
115 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/01/2020
Labeler - Fallien Cosmeceuticals, LTD (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-113)
Establishment
NameAddressID/FEIBusiness Operations
Fragrance Manufacturing Inc. (FMI)793406000MANUFACTURE(58892-113) , PACK(58892-113)

Revised: 1/2022
Document Id: c99218ee-a759-416e-bf2c-a5ea6f1d2bab
Set id: 33f8760c-2953-44a6-9239-424fdb97a5b3
Version: 2
Effective Time: 20220120
 
Fallien Cosmeceuticals, LTD