Label: PRESTIGE CAVIAR FULL MOISTURIZING EMULSION- dimethicone emulsion
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Contains inactivated NDC Code(s)
NDC Code(s): 70519-003-01, 70519-003-02 - Packager: FW1 R&D_Branch
- 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 June 27, 2017
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- DOSAGE & ADMINISTRATION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
Caviar Extract, Water, Glycerin, Butylene Glycol, Niacinamide, Pentaerythrityl Tetraethylhexanoate, 1,2-Hexanediol, Cyclopentasiloxane, Glyceryl Stearate, Limnanthes Alba (Meadowfoam) Seed Oil, Pentylene Glycol, Hydrogenated Poly(C6-14 Olefin), Cetearyl Alcohol, Polyglyceryl-3 Methylglucose Distearate, PEG-40 Stearate, Phenoxyethanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Caprylyl Glycol, Fragrance(Parfum), Carbomer, Tromethamine, Dimethicone/Vinyl Dimethicone Crosspolymer, Xanthan Gum, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate, Squalane, Adenosine, Dextrin, Theobroma Cacao (Cocoa) Extract, Disodium EDTA, Polysorbate 60, Imperata Cylindrica Root Extract, Sorbitan Isostearate, Polydecene, Gardenia Florida Fruit Extract, Saccharide Isomerate, Monascus Extract, PEG-8, Maltodextrin, Caprylic/Capric Triglyceride, Sorbitan Laurate, Hydrogenated Lecithin, Viscum Album (Mistletoe) Fruit Extract, Carthamus Tinctorius (Safflower) Flower Extract, Hydrolyzed Viola Tricolor Extract, Cassia Angustifolia Seed Polysaccharide, Ceramide 3, Hydroxyethylcellulose, Acetyl Dipeptide-1 Cetyl Ester, Sodium Citrate
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PRESTIGE CAVIAR FULL MOISTURIZING EMULSION
dimethicone emulsionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70519-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE 2.6 mg in 130 mL Inactive Ingredients Ingredient Name Strength CAVIAR, UNSPECIFIED (UNII: 020K6HLU0O) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) NIACINAMIDE (UNII: 25X51I8RD4) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) PENTYLENE GLYCOL (UNII: 50C1307PZG) HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-40 STEARATE (UNII: ECU18C66Q7) PHENOXYETHANOL (UNII: HIE492ZZ3T) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC) TROMETHAMINE (UNII: 023C2WHX2V) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ) XANTHAN GUM (UNII: TTV12P4NEE) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) ADENOSINE (UNII: K72T3FS567) ICODEXTRIN (UNII: 2NX48Z0A9G) COCOA (UNII: D9108TZ9KG) EDETATE DISODIUM (UNII: 7FLD91C86K) POLYSORBATE 60 (UNII: CAL22UVI4M) IMPERATA CYLINDRICA ROOT (UNII: VYT2JA85NH) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) HYDROGENATED DIDECENE (UNII: 048B98MT5O) GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549) SACCHARIDE ISOMERATE (UNII: W8K377W98I) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) MALTODEXTRIN (UNII: 7CVR7L4A2D) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SORBITAN MONOLAURATE (UNII: 6W9PS8B71J) HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N) VISCUM ALBUM FRUIT (UNII: P83EQ521R3) SAFFLOWER (UNII: 4VBL71TY4Y) VIOLA TRICOLOR (UNII: 9Q24RAI43V) CERAMIDE NP (UNII: 4370DF050B) HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) ACETYL TYROSYLARGININE CETYL ESTER (UNII: 3M7W78X5IR) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70519-003-02 1 in 1 PACKAGE 06/27/2017 1 NDC:70519-003-01 130 mL 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 final part347 06/27/2017 Labeler - FW1 R&D_Branch (689605458) Registrant - FW1 R&D_Branch (689605458) Establishment Name Address ID/FEI Business Operations Cosmax, Inc 689049693 manufacture(70519-003)