SOLAR PROTECTION FORMULA TIZO SPF 35  SUNSCREEN - zinc oxide lotion 
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 20%

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.

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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Other Information:

Inactive Ingredients:

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, Methicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane, Water

Manufactured exclusively for
Fallien, Ltd.
West Norriton PA 19403
Made in USA

Principal Display Panel – SPF 35 100g Carton Label

NDC 58892-318-01

SOLAR

PROTECTION

FORMULA®

TiZO®

For Ultra

Sensitive Skin

20% Zinc Oxide

Pure Mineral Protection

SPF 35

Broad Spectrum

Water Resistant

(40 minutes)

Net Wt. 3.5 Oz./ 100g

Principal Display Panel – SPF 35 100g Carton Label
SOLAR PROTECTION FORMULA TIZO SPF 35   SUNSCREEN
zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58892-318
Route of Administration TOPICAL DEA Schedule     
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
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Caprylhydroxamic Acid (UNII: UPY805K99W)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Cetyl PEG/PPG-10/1 Dimethicone (HLB 5) (UNII: 035JKJ76MT)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dimethicone 100 (UNII: RO266O364U)  
Dimethicone/Diene Dimethicone Crosspolymer (UNII: RSA9I561OK)  
Edetate Disodium (UNII: 7FLD91C86K)  
Methicone (20 cst) (UNII: 6777U11MKT)  
Microcrystalline Wax (UNII: XOF597Q3KY)  
PEG-10 Dimethicone (600 cst) (UNII: 8PR7V1SVM0)  
PEG-30 Dipolyhydroxystearate (UNII: 9713Q0S7FO)  
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)  
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Sodium Chloride (UNII: 451W47IQ8X)  
Stearyl Dimethicone (400 MPA.S AT 50C) (UNII: R327X197HY)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Trolamine (UNII: 9O3K93S3TK)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Water (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58892-318-01 1 in 1 CARTON
1 100 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 09/02/2012
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
Name Address ID/FEI Business Operations
Custom Analytics LLC 144949372 ANALYSIS(58892-318)
Establishment
Name Address ID/FEI Business Operations
Process Technologies & Packaging 809172885 MANUFACTURE(58892-318)

Revised: 12/2012
Document Id: 3279ee92-0ab5-498e-8483-3e7ee6a00824
Set id: a9de01a9-9b33-4f0e-ac99-0484f3d9fb9e
Version: 1
Effective Time: 20121218
 
Fallien Cosmeceuticals, LTD.