COTZ 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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CoTZ SPF 35 Sunscreen

DRUG FACTS

Active Ingredients:

Zinc Oxide 20%.

Purpose

Sunscreen

Uses

Warnings

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/VinyI Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Lauryl PEG/PPG 18/18 Methicone, Methicone, PEG-10 Dimethicone, Polyhydroxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Tocopheryl Acetate, Triethanolamine, Triethoxycaprylylsilane,

Manufactured
exclusively for
Fallene, Ltd.

West Norriton, PA 19403
Made in USA

Principal Display Panel – 3.5oz Carton Label

NDC 58892-118-01

Dermatologist

Recommended for

Ultra Sensitive Skin

CoTZ®

20% Zinc Oxide

vanishing formula

Pure Mineral

Sun protection

Moisturizing

water resistant

uva/uvb

SPF 35

Net. Wt. 3.5 oz./ 100g

Figure
COTZ SPF 35   SUNSCREEN
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-118
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Caprylhydroxamic Acid (UNII: UPY805K99W)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Cyclomethicone 6 (UNII: XHK3U310BA)  
Cyclomethicone 5 (UNII: 0THT5PCI0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Edetate Disodium (UNII: 7FLD91C86K)  
Glycerin (UNII: PDC6A3C0OX)  
Hydroxystearic Acid (UNII: 933ANU3H2S)  
Polysorbate 20 (UNII: 7T1F30V5YH)  
Sodium Chloride (UNII: 451W47IQ8X)  
Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ)  
.Alpha.-Tocopherol Acetate, D- (UNII: A7E6112E4N)  
Trolamine (UNII: 9O3K93S3TK)  
Triethoxycaprylylsilane (UNII: LDC331P08E)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-118-011 in 1 CARTON
1100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2011
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging809172885MANUFACTURE, PACK
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS
Establishment
NameAddressID/FEIBusiness Operations
Harmony Labs Inc105803274MANUFACTURE, PACK

Revised: 6/2011
Document Id: c8522483-b25f-4948-8976-a6a67d396454
Set id: 47d076f6-df6b-4b76-afb5-f8d56b577f93
Version: 1
Effective Time: 20110607
 
Fallien Cosmeceuticals, LTD.