3CE CRE AMY LIP COLOR 03 ZOOM IN- titanium dioxide lipstick

3CE CRE AMY LIP COLOR 03 ZOOM IN by

Drug Labeling and Warnings

3CE CRE AMY LIP COLOR 03 ZOOM IN by is a Otc medication manufactured, distributed, or labeled by Nanda Co., Ltd, Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 2.6%

INACTIVE INGREDIENT

Inactive Ingredients: Squalane, Caprylic/Capric Triglyceride, Ethylhexyl Hydroxystearate, Butyloctyl Salicylate, PentaerythritylTetraisostearate, Ozokerite, DiglycerylSebacate/Isopalmitate, Polyethylene, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Hydrogenated Polyisobutene, Diisostearyl Malate, Ceresin, Microcrystalline Wax, Dicalcium Phosphate, VP/Eicosene Copolymer, VP/Hexadecene Copolymer, SorbitanIsostearate, Red 28 Lake (CI 45410), Polyglyceryl-2 Triisostearate, Glass, Red 7 (CI 15850:1), Polyglyceryl-2 Diisostearate, Alumina, PhytosterylMacadamiate, Yellow 5 Lake (CI 19140), Iron Oxides (CI 77491), GlycerylCaprylate, Caprylyl Glycol, Blue 1 Lake (CI 42090), Tin Oxide (CI 77861), ArganiaSpinosa Kernel Oil, TheobromaGrandiflorum Seed Butter

PURPOSE

Purpose: Sunscreen

CAUTION

CAUTION: 1. Discontinue use and consult a doctor when - your skin irritates, swells, itches, shows spots on areas applied - your skin reacts similarly with above when exposed to sunlight 2. Avoid applying on wounded, irritated, troubled areas 3. After the use - keep the cap closed - keep it out of children's reach - keep it away from expose to sunlight, high and low temperatures

DESCRIPTION

INSTRUCTIONS: Intense moisturizing lip color lipstick that blends into your lips as soon as it is applied.

Directions: After applying a thin layer of lipstick, another layer of clear lip gloss will allow an additional transparency

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

3CE CRE AMY LIP COLOR 03 ZOOM IN 
titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 60764-113
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.11 g  in 4.5 g

Inactive Ingredients
Ingredient Name	Strength
Squalane (UNII: GW89575KF9)
Ethylhexyl Hydroxystearate (UNII: B7I80BVV5E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 60764-113-02	1 in 1 CARTON	08/10/2016
1	NDC: 60764-113-01	4.5 g in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/10/2016

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Establishment
Name	Address	ID/FEI	Business Operations
Nanda Co., Ltd		557816075	repack(60764-113)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(60764-113)