Label: PRESTIGE CAVIAR FULL MOISTURIZING EMULSION- dimethicone emulsion

  • 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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  • ACTIVE INGREDIENT

    Dimethicone 2.00%

  • PURPOSE

    Skin Protectant

  • INDICATIONS & USAGE

    Helps to prevent dehydration of skin

  • DOSAGE & ADMINISTRATION

    Apply liberally as needed onto skin

  • WARNINGS

    For external use only.
    Do not use on damaged or broken skin.
    When using this product, keep out of eyes. Rinse with water to remove
    Stop using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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

    image description

  • INGREDIENTS AND APPEARANCE
    PRESTIGE CAVIAR FULL MOISTURIZING EMULSION 
    dimethicone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70519-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE2.6 mg  in 130 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70519-003-021 in 1 PACKAGE06/27/2017
    1NDC:70519-003-01130 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/27/2017
    Labeler - FW1 R&D_Branch (689605458)
    Registrant - FW1 R&D_Branch (689605458)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc689049693manufacture(70519-003)
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