COTZ SENSITIVE SPF 40  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.

----------

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:

Inactive Ingredients:

C12-15 Alkyl Benzoate, Caprylhydroxamic Acid, Caprylyl Glycol, Getyl PEG/PPG 10/1 Dimethicone, Cyelohexasiloxane, Cyclopentasiloxane, Dimethicone, Dimethicone Crosspolymer, Dlmethicone/Vinyl Dimethicone Crosspolymer, Dimethiconol, Disodium EDTA, Glycerin, Methicone, Microcrystalline Wax, PEG-10 Dimethicone, PEG-30 Dipolyhydroxystearate, Polyglyceryl-4 Isostearate, Polyhydraxystearic Acid, Polysorbate 20, Sodium Chloride, Stearyl Dimethicone, Tetrahexadecyl Ascorbate, Triethanolamine, Triethoxycaprylylsilane, Water

Other Information:

Principal Display Panel – SPF 40 100g Carton Label

DERMATOLOGIST RECOMMENDED

CoTZ®

SENSITIVE

The Healthier SunscreenTM Gentle Mineral ComplexTM #1 Rated UV Protection*
Will Not Irritate

Helps Prevent Heat Build-Up in Skin
which can Damage the Dermis

100% Free of:

Chemical Sunscreens, Oils, Fragrances

SPF 40
Broad
Spectrum
UVA-UVB

Soft & Sheer
Water Resistant
(40 minutes)

Net Wt. 3.5 oz/100 g

Principal Display Panel – SPF 40 100g Carton Label
COTZ SENSITIVE SPF 40   SUNSCREEN
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-418
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-418-011 in 1 CARTON
1100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/30/2012
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-418)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging809172885MANUFACTURE(58892-418)

Revised: 12/2012
Document Id: 7956ec06-a9ce-46d4-a721-e5c21ee1d18c
Set id: 885a674b-3457-4dfe-a801-529094b00499
Version: 1
Effective Time: 20121218
 
Fallien Cosmeceuticals, LTD.