COTZ LIP BALM  LIP BALM/SUNSCREEN- titanium dioxide, zinc oxide lipstick 
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 4.0%

Zinc Oxide 5.5%

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:

Alumina, Aluminum Hydroxide, Aluminum Stearate, Ascorbic Add, Ascorbyl Palmitate, C12-15 Alkyl Benzoate, Cetearyl Isononanoate, Cetyl PEG/PPG-15/15 Butyl Ether Dimethicone, Citric Add, Dipropylene Glycol Dicaprylate-Caprate, Ethylhexyl Palmitate, Flavor, Helianthus Annuus (Sunflower) Seed Wax, Hexyldecanol, Hexyldecyl Laurate, Iron Oxide, Lecithin, Ozokerite, PEG-8, Polyglyceryl-3 Diisostearate, Polyhydroxystearic Acid, Stearic Acid, Tocopherol, Tocopheryl Acetate, Zingiber Officinale (Ginger) Root Oil

Other Information:

Principal Display Panel – 4.5 g Carton Label

CoTZ®

LIP BALM

The Healthier Lip BalmTM

100% Free of:

Chemical Sunscreens, Oils,

Lanolin, Gluten

SPF45

Broad

Spectrum

UVA-UVB

WATER RESISTANT

(80 MINUTES)

Net Wt. .14 oz/4.5 g

Principal Display Panel – 4.5 g Carton Label
COTZ LIP BALM   LIP BALM/SUNSCREEN
titanium dioxide, zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide40 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide55 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aluminum Oxide (UNII: LMI26O6933)  
Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
Aluminum Stearate (UNII: U6XF9NP8HM)  
Ascorbic Acid (UNII: PQ6CK8PD0R)  
Ascorbyl Palmitate (UNII: QN83US2B0N)  
C12-15 Alkyl Benzoate (UNII: A9EJ3J61HQ)  
Ceresin (UNII: Q1LS2UJO3A)  
Cetearyl Isononanoate (UNII: P5O01U99NI)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Propylene Glycol Dicaprylate/Dicaprate (UNII: O4446S9CRA)  
Ethylhexyl Palmitate (UNII: 2865993309)  
Kiwi Fruit (UNII: 71ES77LGJC)  
Lime (Citrus) (UNII: 8CZS546954)  
Sunflower Oil (UNII: 3W1JG795YI)  
Hexyldecanol (UNII: 151Z7P1317)  
Hexyldecyl Laurate (UNII: 0V595C1P6M)  
Ferric Oxide Red (UNII: 1K09F3G675)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Polyethylene Glycol 400 (UNII: B697894SGQ)  
Stearic Acid (UNII: 4ELV7Z65AP)  
.Alpha.-Tocopherol (UNII: H4N855PNZ1)  
.ALPHA.-Tocopherol Acetate, D- (UNII: A7E6112E4N)  
Ginger Oil (UNII: SAS9Z1SVUK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58892-126-871 in 1 CARTON
14.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/02/2004
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS(58892-126)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging809172885MANUFACTURE(58892-126) , PACK(58892-126)

Revised: 12/2012
Document Id: e51f9ed7-389f-4b5b-b9b3-5a408350a7bb
Set id: a3345cf5-5e48-4052-b5c2-65633869de5a
Version: 2
Effective Time: 20121228
 
Fallien Cosmeceuticals, LTD.