COTZ PURE SPF 30 SUNSCREEN- titanium dioxide, zinc oxide cream

Cotz Pure SPF 30 by

Drug Labeling and Warnings

Cotz Pure SPF 30 by is a Otc medication manufactured, distributed, or labeled by Fallien Cosmeceuticals, LTD., Custom Analytics LLC, Process Technologies & Packaging. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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:

• Apply liberally 15 minutes before sun exposure.
• Reapply:
  • - After 40 minutes of swimming or sweating
  • - Immediately after towel drying
  • - At least every 2 hours
• Children under 6 months: Ask a doctor
• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • - Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • - Wear long-sleeved shirts, pants, hats, and sunglasses

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

INGREDIENTS AND APPEARANCE

COTZ PURE SPF 30   SUNSCREEN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	41 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	84 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-600-01	1 in 1 CARTON
1		85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/14/2012

Labeler - Fallien Cosmeceuticals, LTD. (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	ANALYSIS(58892-600)

Establishment
Name	Address	ID/FEI	Business Operations
Process Technologies & Packaging		809172885	MANUFACTURE(58892-600) , PACK(58892-600)