LipCoTZ Lip Balm/Sunscreen

Dosage form: lipstick
Ingredients: Titanium Dioxide 40mg in 1g, Zinc Oxide 55mg in 1g
Labeler: Fallien Cosmeceuticals, LTD.
NDC Code: 58892-125

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.

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

LIPCOTZ   LIP BALM/SUNSCREEN
titanium dioxide, zinc oxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58892-125
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (Titanium Dioxide) Titanium Dioxide40 mg  in 1 g
Zinc Oxide (Zinc Oxide) Zinc Oxide55 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Aluminum Oxide 
Aluminum Hydroxide 
Aluminum Stearate 
Ascorbic Acid 
Ascorbyl Palmitate 
C12-15 Alkyl Benzoate 
Ceresin 
Cetearyl Isononanoate 
Anhydrous Citric Acid 
Propylene Glycol Dicaprylate/Dicaprate 
Ethylhexyl Palmitate 
Kiwi Fruit 
Lime (Citrus) 
Sunflower Oil 
Hexyldecanol 
Hexyldecyl Laurate 
Ferric Oxide Red 
Lecithin, Soybean 
Polyethylene Glycol 400 
Stearic Acid 
Alpha-Tocopherol 
.ALPHA.-Tocopherol Acetate, D- 
Ginger Oil 
Packaging
#Item CodePackage Description
1NDC:58892-125-871 TUBE (1 STICK) 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/FEIOperations
Process Technologies & Packaging809172885MANUFACTURE, PACK
Establishment
NameAddressID/FEIOperations
Custom Analytics LLC144949372ANALYSIS

Revised: 09/2010
 
Fallien Cosmeceuticals, LTD.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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