Label: 3CE CRE AMY LIP COLOR 01 PICK ME UP- titanium dioxide lipstick
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Contains inactivated NDC Code(s)
NDC Code(s): 60764-112-01, 60764-112-02 - Packager: Nanda Co., Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated October 13, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients: Squalane, Caprylic/Capric Triglyceride, Ethylhexyl Hydroxystearate, Butyloctyl Salicylate, Polyglyceryl-2 Triisostearate, Ozokerite, Polyethylene, DiglycerylSebacate/Isopalmitate, Phytosteryl/Isostearyl/Cetyl/Stearyl/Behenyl Dimer Dilinoleate, Hydrogenated Polyisobutene, Ceresin, Microcrystalline Wax, Yellow 6 Lake (CI 15985), Diisostearyl Malate, PentaerythritylTetraisostearate, Dicalcium Phosphate, VP/Eicosene Copolymer, VP/Hexadecene Copolymer, SorbitanIsostearate, Red 7 (CI 15850:1), Polyglyceryl-2 Diisostearate, Alumina, Red 6 (CI 15850), PhytosterylMacadamiate, Yellow 5 Lake (CI 19140), GlycerylCaprylate, Caprylyl Glycol, ArganiaSpinosa Kernel Oil, TheobromaGrandiflorum Seed Butter
- PURPOSE
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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
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
3CE CRE AMY LIP COLOR 01 PICK ME UP
titanium dioxide lipstickProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60764-112 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 0.02 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:60764-112-02 1 in 1 CARTON 08/10/2016 1 NDC:60764-112-01 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(60764-112) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(60764-112)
