Label: LUXURY REVITALIZING NOURISHING CREAM- glycerin. dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 20151-082-01, 20151-082-02 - Packager: Casmara Cosmetics, SA
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 February 21, 2017
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- Official Label (Printer Friendly)
- Warnings
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- Other Information
- Directions
- Uses
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Inactive Ingredients
Water, Butylene Glycol Dicaprylate/Dicaprate, Dimethicone, 4-Methylbenzylidene Camphor , Ethylhexyl methoxycinnamate, Propylene glycol, Argan kernel oil, Cetyl alcohol , Glyceryl stearate, Camellia japonica seed oil, Phenoxyethanol, PEG-75 stearate, Dimethicone crosspolymer, Oat protein extract, Ascorbic acid/Orange/Citrus limon/Citrus aurantifolia polypeptides, Ceteth-20, Steareth-20, Xanthan gum, Fragrance, Tocopherol/Wheat polypeptides, Ethylhexylglycerin, Tetrasodium glutamate diacetate, Limonene, Bitter orangeflower extract, Maltodextrin, Retinyl palmitate/Carrot polypeptide, Linalool, BHT, Calcium sulfate, Silica, Citral, Magnesium sulfate,Copper sulfate, Potassium sulfate, Zinc sulfate, Manganese sulfate, Ferric sulfate
- Uses
- ACTIVE INGREDIENTS PURPOSE
- Package Label
- Hydra lifting Firming Nourishing Cream See below image
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INGREDIENTS AND APPEARANCE
LUXURY REVITALIZING NOURISHING CREAM
glycerin. dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20151-082 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 3.36 mg in 1 mL GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength POTASSIUM SULFATE (UNII: 1K573LC5TV) 0.00025 mL in 1 mL FERRIC SULFATE (UNII: 3HWS7HF5XD) 0.00005 mL in 1 mL MANGANESE SULFATE (UNII: W00LYS4T26) 0.0001 mL in 1 mL ZINC SULFATE (UNII: 89DS0H96TB) 0.000017 mg in 1 mL CALCIUM SULFATE (UNII: WAT0DDB505) 0.003 mL in 1 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.069 mL in 1 mL MAGNESIUM SULFATE (UNII: DE08037SAB) 0.00065 mL in 1 mL CITRAL (UNII: T7EU0O9VPP) 0.001 mL in 1 mL HYDRATED SILICA (UNII: Y6O7T4G8P9) 0.001 mL in 1 mL CETETH-20 (UNII: I835H2IHHX) 0.26 mL in 1 mL ENZACAMENE (UNII: 8I3XWY40L9) 3 mL in 1 mL DIPROPYLENE GLYCOL (UNII: E107L85C40) 2.5 mL in 1 mL BASIC COPPER SULFATE (UNII: CUP529P5NS) 0.0005 mL in 1 mL GLYCERYL STEARATE SE (UNII: FCZ5MH785I) 1.4 mL in 1 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mL in 1 mL WATER (UNII: 059QF0KO0R) 59.74 mL in 1 mL XANTHAN GUM (UNII: TTV12P4NEE) 0.2 mL in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mL in 1 mL TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mL in 1 mL CETYL ALCOHOL (UNII: 936JST6JCN) 1.4 mL in 1 mL HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) 0.5 mL in 1 mL TOCOPHEROL (UNII: R0ZB2556P8) 0.134 mL in 1 mL ARGAN OIL (UNII: 4V59G5UW9X) 2 mL in 1 mL BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.013 mL in 1 mL MALTODEXTRIN (UNII: 7CVR7L4A2D) 0.036 mL in 1 mL BITTER ORANGE OIL (UNII: 9TLV70SV6I) 0.063 mL in 1 mL PERFLUNAFENE (UNII: 54A06VV62N) 0.2 mL in 1 mL STEARETH-20 (UNII: L0Q8IK9E08) 0.26 mL in 1 mL ASCORBIC ACID (UNII: PQ6CK8PD0R) 0.335 mL in 1 mL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) 0.64 mL in 1 mL PEG-75 STEARATE (UNII: OT38R0N74H) 0.68 mL in 1 mL CAMELLIA JAPONICA SEED OIL (UNII: U37N0S910T) 1 mL in 1 mL BUTYLENE GLYCOL DICAPRATE (UNII: 3Z317CA098) 8 mL in 1 mL LINALOOL, (+)- (UNII: F4VNO44C09) 0.013 mL in 1 mL VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.031 mL in 1 mL OCTINOXATE (UNII: 4Y5P7MUD51) 2.99 mL in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20151-082-02 1 in 1 BOTTLE, DISPENSING 02/21/2017 1 NDC:20151-082-01 50 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part347 02/21/2017 Labeler - Casmara Cosmetics, SA (464973544) Registrant - Casmara Cosmetics, SA (464973544) Establishment Name Address ID/FEI Business Operations Casmara Cosmetics, SA 464973544 manufacture(20151-082)