LIPCOTZ  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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LIPCŌTZ

Drug Facts

Active Ingredients

Titanium Dioxide 4.0%

Zinc Oxide 5.5%

Purpose

Sunscreen

Sunscreen

Uses:

Helps prevent sunburn; higher SPF gives more sunburn protection for skin that sunburns easily

Warnings:

For External Use Only. Stop use and consult a physician if rash or irritation develops. Avoid contact with eyes.

Keep out of reach of children:

If swallowed, get medical help or contact a Poison Control Center.

Directions:

Apply generously to lips prior to sun exposure. Reapply often and after water activity, excessive perspiration or towel drying. Children under 6 years old, consult a physician.

Inactive Ingredients:

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

Principal Display Panel – Carton Label

NDC 58892-125-87

SPF 45

LIPCŌTZ

Contains Only Titanium & Zinc™

SPF 45

Contains Only Titanium & Zinc™

Ultra High Sun Protection no chemical sunscreen filters

Net Wt. .14 Oz./ 4.5 g

For Information Call:

800-332-5536

Manufactured for: Fallene, Ltd

West Norriton, PA

Principal Display Panel – Carton Label
LIPCOTZ   LIP BALM/SUNSCREEN
titanium dioxide, zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-125
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:58892-125-871 in 1 CARTON
14.5 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/01/2005
Labeler - Fallien Cosmeceuticals, LTD. (958388357)
Establishment
NameAddressID/FEIBusiness Operations
Process Technologies & Packaging809172885MANUFACTURE, PACK
Establishment
NameAddressID/FEIBusiness Operations
Custom Analytics LLC144949372ANALYSIS

Revised: 9/2010
Document Id: 5d4a9076-4a63-4ea3-8776-802e06fba806
Set id: 0d0bd849-3f96-4d7a-9ca9-7cf93f4e001b
Version: 1
Effective Time: 20100909
 
Fallien Cosmeceuticals, LTD.