COTZ PURE SPF 30  SUNSCREEN - titanium dioxide, 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:

Titanium Dioxide 4.1%

Zinc Oxide 8.4%

Purpose

Sunscreen

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:

Brassica Campestris/Aleurites Fordii Oil Copolymer1 (from rapeseed and aleurites oils), Butyrospermum Parkii (Shea) Butter1 (shea tree extract), Camellia Oleifera Leaf Extract1 (Japanese green tea), Capric/Caprylic Triglyceride1,2,3(from coconut), Cellulose Gum1(from plant), Cetearyl Alcohol1,2,3(from coconut/ palm), Cetearyl Glucoside1,2,3(from coconut/palm and glucose sugar), Citric Acid (from citrus fruit), Glyceryl Caprylate1,2(from coconut), Glyceryl Undecylenate1,2(from castor bean and coconut glycerin), Iron Oxide1 (CI 77491) (natural mineral), Melissa Officinalis (Balm Mint) Extract1 (natural herb), Microcrystalline Cellulose1 (from wood pulp), Polyhydroxystearic Acid2(from castor plant), Rosmarinus Officinalis (Rosemary) Extract1 (natural herb), Salvia Officinalis (Sage) Leaf Extract1 (natural herb), Simmondsia Chinensis (Jojoba) Esters1,2(from natural plant) Sodium Stearoyl Glutamate1,2,3(from coconut and amino acid), Sorbitan Oleate Decylglucoside Crosspolymer4(from sugar and plant derived oleic acid), Xanthan Gum1(from plant sugar), Water

Other Information:

-
Protect this product from excessive heat and direct sun
-
May stain some fabrics

* All ingredients approved by one or more of these leading organizations: 1. Natural Products Association, 2. EcoCert, 3 NSF International, 4. Green Star Rated

Principal Display Panel – SPF 30 85g Carton Label

DERMATOLOGIST RECOMMENDED

CoTZ®

PURE

The Healthier Sunscreen
0%
Synthetic Ingredients
Preservatives
Chemical Sunscreens

Balanced Mineral ComplexTM Helps Prevent
Heat Build-Up in Skin, which Can
Damage the Dermis

Broad
Spectrum
SPF 30

Silky Soft & Gentle
Water Resistant
(40 minutes)

Net Wt. 3.5 oz/85.0 g

Principal Display Panel – SPF 30 85g Carton Label
COTZ PURE SPF 30   SUNSCREEN
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-600
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide41 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide84 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Shea Butter (UNII: K49155WL9Y)  
Camellia Oleifera Leaf (UNII: 5077EL0C60)  
Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
Carboxymethylcellulose Sodium (UNII: K679OBS311)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Cetearyl Glucoside (UNII: 09FUA47KNA)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Glyceryl Caprylate (UNII: TM2TZD4G4A)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Melissa Officinalis (UNII: YF70189L0N)  
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
Rosemary (UNII: IJ67X351P9)  
Sage (UNII: 065C5D077J)  
Sodium Stearoyl Glutamate (UNII: 65A9F4P024)  
Xanthan Gum (UNII: TTV12P4NEE)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-600-011 in 1 CARTON
185 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/14/2012
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-600)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging809172885MANUFACTURE(58892-600) , PACK(58892-600)

Revised: 12/2012
Document Id: 4d32c38b-7b9d-4c85-b279-af8d55c3b9b3
Set id: c114a1bc-60c1-49ad-a244-71d4b6d95d21
Version: 1
Effective Time: 20121218
 
Fallien Cosmeceuticals, LTD.