Label: 3CE EYE SHADOW PALETTE SADDLE- titanium dioxide powder
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Contains inactivated NDC Code(s)
NDC Code(s): 60764-065-01, 60764-065-02 - 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 4, 2016
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- ACTIVE INGREDIENT
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INACTIVE INGREDIENT
Inactive Ingredients:
A) Mica (CI 77019), Talc, Iron Oxides (CI 77491), Nylon-12, Neopentyl Glycol Diethylhexanoate, Phenyl Trimethicone, Magnesium Myristate, Magnesium Stearate, Silica, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Iron Oxides (CI 77492), Polybutene, Propanediol, Dimethicone, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Sodium Dehydroacetate, Hydrogenated Lecithin, Tin Oxide (CI 77861)
B)~D) Mica (CI 77019), Talc, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491), Nylon-12, Neopentyl Glycol Diethylhexanoate, Phenyl Trimethicone, Magnesium Myristate, Magnesium Stearate, Silica, Diisostearyl Malate, Dipentaerythrityl Hexahydroxystearate/Hexastearate/Hexarosinate, Octyldodecyl Stearoyl Stearate, Isostearyl Neopentanoate, Iron Oxides (CI 77492), Polybutene, Propanediol, Dimethicone, Iron Oxides (CI 77499), Triethoxycaprylylsilane, Sodium Dehydroacetate, Hydrogenated Lecithin, Tin Oxide (CI 77861)
- PURPOSE
- CAUTION
- DESCRIPTION
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
3CE EYE SHADOW PALETTE SADDLE
titanium dioxide powderProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:60764-065 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide 0.68 g in 8 g Inactive Ingredients Ingredient Name Strength Mica (UNII: V8A1AW0880) Talc (UNII: 7SEV7J4R1U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:60764-065-02 1 in 1 CARTON 08/20/2016 1 NDC:60764-065-01 8 g in 1 CONTAINER; 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 08/20/2016 Labeler - Nanda Co., Ltd (557816075) Registrant - Nanda Co., Ltd (557816075) Establishment Name Address ID/FEI Business Operations Nanda Co., Ltd 557816075 repack(60764-065) Establishment Name Address ID/FEI Business Operations Cosmax, Inc. 689049693 manufacture(60764-065)
