3CE CRE AMY LIP COLOR 16 GIDDY UP- 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.

----------

ACTIVE INGREDIENT

Active Ingredient: Titanium Dioxide 2.0%

PURPOSE

Purpose: Sunscreen

INACTIVE INGREDIENT

Inactive Ingredients: Squalane, Caprylic/Capric Triglyceride, Ethylhexyl Hydroxystearate, Butyloctyl Salicylate, Ozokerite, Polyglyceryl-2 Triisostearate, Diglyceryl Sebacate/Isopalmitate, VP/Hexadecene Copolymer, Polyethylene, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Hydrogenated Polyisobutene, Red 28 Lake (CI 45410), Ceresin, Microcrystalline Wax, Diisostearyl Malate, Sorbitan Isostearate, Dicalcium Phosphate, VP/Eicosene Copolymer, Polyglyceryl-2 Diisostearate, Alumina, Red 6 (CI 15850), Phytosteryl Macadamiate, Red 22 Lake (CI 45380), Pentaerythrityl Tetraisostearate, Yellow 6 Lake (CI 15985), Glyceryl Caprylate, Caprylyl Glycol, Argania Spinosa Kernel Oil, Theobroma Grandiflorum Seed Butter, Yellow 5 Lake (CI 19140)

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 16 GIDDY UP 
titanium dioxide lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60764-124
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide0.09 g  in 4.5 g
Inactive Ingredients
Ingredient NameStrength
Squalane (UNII: GW89575KF9)  
Ethylhexyl Hydroxystearate (UNII: B7I80BVV5E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:60764-124-021 in 1 CARTON08/10/2016
1NDC:60764-124-014.5 g in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/10/2016
Labeler - Nanda Co., Ltd (557816075)
Registrant - Nanda Co., Ltd (557816075)
Establishment
NameAddressID/FEIBusiness Operations
Nanda Co., Ltd557816075repack(60764-124)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(60764-124)

Revised: 10/2016
Document Id: 8d0eb702-a012-4e66-967c-f44f106b2fe5
Set id: c8e1b4bf-7999-4b10-9080-86fb63de584c
Version: 1
Effective Time: 20161014
 
Nanda Co., Ltd