Label: LUXURY REVITALIZING NOURISHING CREAM- 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 February 21, 2017

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

  • 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.

    WARNINGS

    Stop use and ask a doctor if rash occurs

    Children under 6 months: ask a doctor

    Warnings

    Keep out of reach of children

  • Questions or comments?

    + 34 961 501 999 M-F 9:00 am to 5:00 pm

  • Other Information

    . keep the product in a cool and dry place

  • Directions

    . apply every day gently onto clean face and neck

    . can be used in the morning and/or night

    . apply every day gently onto clean dace and neck

    . can be used in the morning and/or night

  • Uses

    . helps to prevent dehydration of the skin.

    . helps maintain the hydrolipidic layer of the skin

    . helps to combat the signs of ageing

  • 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

    . helps to prevent dehydration of the skin

    . helps maintain the hydrolipidic layer of the skin

    . helps to nourish the skin

  • ACTIVE INGREDIENTS PURPOSE

    Bottle

    Glycerin 10%.................... Skin Protectant

  • Package Label

    Npurishing box

  • Hydra lifting Firming Nourishing Cream See below image

    Hydra lifting

    Firming Nourishing Cream

    Skin Protectant

    Nourished Skin

    Box

  • INGREDIENTS AND APPEARANCE
    LUXURY REVITALIZING NOURISHING CREAM 
    glycerin. dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-082
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE3.36 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-082-021 in 1 BOTTLE, DISPENSING02/21/2017
    1NDC:20151-082-0150 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34702/21/2017
    Labeler - Casmara Cosmetics, SA (464973544)
    Registrant - Casmara Cosmetics, SA (464973544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Casmara Cosmetics, SA464973544manufacture(20151-082)