3CE CRE AMY LIP COLOR 13 VEG AS NIGHT- titanium dioxide lipstick
Nanda Co., 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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ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 0.7%

INACTIVE INGREDIENT

Inactive Ingredients: Squalane, Caprylic/Capric Triglyceride, Pentaerythrityl Tetraisostearate, Ethylhexyl Hydroxystearate, Butyloctyl Salicylate, Polyglyceryl-2 Triisostearate, Ozokerite, Ceresin, Diglyceryl Sebacate/Isopalmitate, Polyethylene, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Hydrogenated Polyisobutene, Microcrystalline Wax, Red 6 (CI 15850), Dicalcium Phosphate, VP/Eicosene Copolymer, VP/Hexadecene Copolymer, Sorbitan Isostearate, Alumina, Diisostearyl Malate, Phytosteryl Macadamiate, Yellow 6 Lake (CI 15985), Glyceryl Caprylate, Caprylyl Glycol, Yellow 5 Lake (CI 19140), Argania Spinosa Kernel Oil, Theobroma Grandiflorum 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

Image of carton

3CE CRE AMY LIP COLOR 13 VEG AS NIGHT
titanium dioxide lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:60764-121
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	0.03 g in 4.5 g

Ingredient Name	Strength
Inactive Ingredients
Squalane (UNII: GW89575KF9)
Pentaerythrityl Tetraisostearate (UNII: 9D7IK5483F)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:60764-121-02	1 in 1 CARTON	08/10/2016
1	NDC:60764-121-01	4.5 g in 1 BOTTLE; Type 0: Not a Combination Product

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

Labeler - Nanda Co., Ltd (557816075)

Registrant - Nanda Co., Ltd (557816075)

Name	Address	ID/FEI	Business Operations
Establishment
Nanda Co., Ltd		557816075	repack(60764-121)

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(60764-121)