Label: LUXURY REVITALIZING SERUM- glycerin, dimethicone cream
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Contains inactivated NDC Code(s)
NDC Code(s): 20151-063-01, 20151-063-02 - 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 November 1, 2016
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- Uses
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Inactive ingredients
water, phenoxyethanol, biosaccharide gum-1, PEG-40 castor oil, ascorbic acid, sodium levulinate, glyceryl caprylate, sodium polyacrylate, alpha-tocopherol, dimethicone, perflunafene, ethylhexylglycerin, tetrasodium glutamate diacetate, sodium anisate, cyplopentasiloxane, trideceth-6, limonene, Vitamin A- Palmitate, ethylbisiminomethylguaiacol manganase chloride, PEG-PPG 18/18 dimethicone, linalool.
- Directions
- Active Ingredients Purpose
- Luxury Revitalizing Serum
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INGREDIENTS AND APPEARANCE
LUXURY REVITALIZING SERUM
glycerin, dimethicone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:20151-063 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 15 mg in 1 mL DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 0.13 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM ANISATE (UNII: F9WFJ28MV9) 0.08 mg in 1 mL GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) 0.21 mg in 1 mL WATER (UNII: 059QF0KO0R) 81.17 mg in 1 mL DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6) 0.069 mg in 1 mL ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg in 1 mL TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg in 1 mL PERFLUNAFENE (UNII: 54A06VV62N) 0.1 mg in 1 mL PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg in 1 mL PEG-40 CASTOR OIL (UNII: 4ERD2076EF) 0.5 mg in 1 mL LINALOOL, (+)- (UNII: F4VNO44C09) 0.006 mg in 1 mL BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H) 0.057 mg in 1 mL SODIUM LEVULINATE (UNII: VK44E1MQU8) 0.288 mg in 1 mL .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) 0.13 mg in 1 mL TRIDECETH-6 (UNII: 3T5PCR2H0C) 0.042 mg in 1 mL LIMONENE, (+)- (UNII: GFD7C86Q1W) 0.03 mg in 1 mL ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU) 0.01 mg in 1 mL PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) 0.007 mg in 1 mL ASCORBIC ACID (UNII: PQ6CK8PD0R) 0.33 mg in 1 mL SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) 0.18 mg in 1 mL VITAMIN A PALMITATE (UNII: 1D1K0N0VVC) 0.031 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:20151-063-02 1 in 1 BOTTLE, PLASTIC 04/15/2016 1 NDC:20151-063-01 50 mL in 1 BOTTLE, PLASTIC; 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 08/11/2015 Labeler - CASMARA COSMETICS, SA (464973544) Registrant - CASMARA COSMETICS, SA (464973544) Establishment Name Address ID/FEI Business Operations CASMARA COSMETICS, SA 464973544 manufacture(20151-063)