Label: LIGHTENING BRIGHTENING MOISTURIZING SERUM- glycerin 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 April 6, 2017

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

  • ACTIVE INGREDIENTS PURPOSE

    Glycerin 30%.................... Skin Protectant

    Bottle

  • 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 to clean face, neck and chest and hands until the product has been absorbed.

    . used in the morning and/or night

    . apply to clean face, neck and chest and hands until the product has been absorbed.

    . used in the morning and/or night

  • Uses

    . provides an intense dose of hydration, clarity and shine

  • Inactive Ingredients

    Water, Propylene glycol, Butylene glycol, Saxifraga sarmentosa extract, Vitis vinifera fruit extract, Phenoxyethanol, Erythritol, Ascorbyl Glucoside, Palmaria palmata extract, Xanthan gum, Ethylhexylglycerin, Tetrasodium glutamate diacetate, Morus Bombycis Root, Extract, Scutellaria Baicalensis Extract, Disodium EDTA, Dextran, Nonapeptide-1, Sodium sulfite, Sodium metabisulfite, Sodium benzoate, Potassium sorbate, Homarine HCL

  • Uses

    . provides an intense dose of hydration, clarity and shine

  • Package Label

    Box

  • INGREDIENTS AND APPEARANCE
    LIGHTENING BRIGHTENING MOISTURIZING SERUM 
    glycerin cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE) 0.1 mg  in 1 mL
    MORUS AUSTRALIS ROOT (UNII: 1VL55O45RF) 0.09 mg  in 1 mL
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 3.82 mg  in 1 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.009 mg  in 1 mL
    WINE GRAPE (UNII: 3GOV20705G) 1.125 mg  in 1 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 48.935 mg  in 1 mL
    SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H) 1.125 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg  in 1 mL
    ERYTHRITOL (UNII: RA96B954X6) 0.6 mg  in 1 mL
    DULSE (UNII: 7832HOY4ZQ) 0.225 mg  in 1 mL
    SODIUM METABISULFITE (UNII: 4VON5FNS3C) 0.012 mg  in 1 mL
    SODIUM SULFITE (UNII: VTK01UQK3G) 0.012 mg  in 1 mL
    ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW) 0.5 mg  in 1 mL
    NONAPEPTIDE-1 (UNII: 64W45420K5) 0.06 mg  in 1 mL
    DEXTRAN 40 (UNII: K3R6ZDH4DU) 0.06 mg  in 1 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.076 mg  in 1 mL
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S) 0.09 mg  in 1 mL
    PROPANEDIOL (UNII: 5965N8W85T) 12 mg  in 1 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.009 mg  in 1 mL
    HOMARINE HYDROCHLORIDE (UNII: 8866LNG61N) 0.006 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-102-021 in 1 BOTTLE, DISPENSING04/06/2017
    1NDC:20151-102-0150 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 finalpart34703/29/2017
    Labeler - Casmara Cosmetics, SA (464973544)
    Registrant - Casmara Cosmetics, SA (464973544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Casmara Cosmetics, SA464973544manufacture(20151-102)