LIPCOTZ- titanium dioxide, zinc oxide lipstick

LipCoTZ by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

LIPCOTZ   LIP BALM/SUNSCREEN
titanium dioxide, zinc oxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58892-125
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	40 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	55 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58892-125-87	1 in 1 CARTON
1		4.5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/01/2005

Labeler - Fallien Cosmeceuticals, LTD. (958388357)

Establishment
Name	Address	ID/FEI	Business Operations
Process Technologies & Packaging		809172885	MANUFACTURE, PACK

Establishment
Name	Address	ID/FEI	Business Operations
Custom Analytics LLC		144949372	ANALYSIS