Label: LUXURY REVITALIZING SERUM- glycerin, dimethicone cream

  • 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

If you are a consumer or patient please visit this version.

  • Uses

    . helps to prevent dehydration of the skin.

    . helps maintain the hydrolipidic layer of the skin

  • Uses

    . helps to prevent dehydration of the skin

    . helps maintain the hydrolipidic layer of the skin

  • Warnings

    For external use only.

    Do not use on damaged or broken skin.

    When using this product keep our of the eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

    Whhen using this product do not get into eyes.

    Children under 6 months: as a doctor.

    Keep out of reach of children.

  • Warnings

    Stop use and ask a doctor if rash occurs.

  • Questions or comments?

    (305) 777-0548 M-F 9:00 am to 5:00 pm

  • Directions

    . apply every day gently onto clean face and neck.

    . can be used in the morning and/or night.

  • Other information

    . keep the product in a cool and dry place.

  • 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

    . apply every day gently onto clean face and neck

    . can be used in the morning and/or night

  • Active Ingredients Purpose

    Active Ingredients Purpose

    Glycerin 15%.................... Skin Protectant

    Dimethicone 0.133%.........Skin Protectant

    Serum bottle

  • Luxury Revitalizing Serum

    Luxury
    Revitalizing Serum
    Skin Protectant
    Moisturizing & Firming

    Serum box

  • Principal Display Panel

    Luxury Revitalizing Serum

    Skin Protectant

    Moisturizing & Firming

    serum box

  • INGREDIENTS AND APPEARANCE
    LUXURY REVITALIZING SERUM 
    glycerin, dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN15 mg  in 1 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-063-021 in 1 BOTTLE, PLASTIC04/15/2016
    1NDC:20151-063-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/11/2015
    Labeler - CASMARA COSMETICS, SA (464973544)
    Registrant - CASMARA COSMETICS, SA (464973544)
    Establishment
    NameAddressID/FEIBusiness Operations
    CASMARA COSMETICS, SA464973544manufacture(20151-063)