Label: CLEANSER BALANCING- glycerin, dimethicone liquid

  • 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.

  • WARNINGS

    For external use only.

    Do not use on damaged or broken skin.

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children.

    Avoid the product from entering your eyes.

    Children under 6 months: as a doctor.

  • ASK DOCTOR

    Stop use and ask a doctor if rash occurs

    Children under 6 months: ask a doctor

  • KEEP OUT OF REACH OF CHILDREN

    . keep out of reach of children

  • Questions or Comments?

    Questions or comments? + 34 961 501 099 M-F 9:00 am to 5:00 pm

  • OTHER SAFETY INFORMATION

    . keep the product in a cool and dry place

  • Directions

    . apply directly to the damp face, lather and rinse off with plenty of water.

    . for made up eyes use a damp cotton pad impregnated with the product, then rinse with water

  • DOSAGE & ADMINISTRATION

    . apply directly to the damp face, lather and rinse off with plenty of water.

    . for made up eyes use a damp cotton pad impregnated with the product, then rinse with water

  • Uses

    . removes excess oil and dirty without drying

  • INACTIVE INGREDIENT

    water, sodium laureth sulfate, avocado oil, sodium polyacrylate, phenoxyethanol, xanthan gum, cyclopentasiloxane, trideceth-6, sodium chloride, ethylhexylglycerin, fragrance, tetrasodium glutamate diacetate, lycium barbarum fruit extract, PEG/PPG-18/18 dimethicone, sodium benzoate, linalool, postasium sorbate, butylated hydroxytoluene, sorbic acid, ascorbyl palmitate.

    Bottle 2

  • PURPOSE

    . removes excess oil and dirty without drying.

  • Active Ingredients

    Glycerin 5,35%........................... Skin Protectant

    Dimethicone 0,76%.....................Skin Protectant

  • PRINCIPAL DISPLAY PANEL

    Cleanser Balancing

    Skin protectant

    Multifuntional action

    Balance

    Facial Collection

    Bottle 500

  • INGREDIENTS AND APPEARANCE
    CLEANSER BALANCING 
    glycerin, dimethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.76 mg  in 1 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5.35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ASCORBYL PALMITATE (UNII: QN83US2B0N) 0.0006 mg  in 1 mL
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) 0.01 mg  in 1 mL
    SORBIC ACID (UNII: X045WJ989B) 0.002 mg  in 1 mL
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4) 0.01 mg  in 1 mL
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0) 2.7 mg  in 1 mL
    AVOCADO OIL (UNII: 6VNO72PFC1) 1.5 mg  in 1 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 86.02 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg  in 1 mL
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) 1.04 mg  in 1 mL
    PERFLUNAFENE (UNII: 54A06VV62N) 0.1 mg  in 1 mL
    XANTHAN GUM (UNII: TTV12P4NEE) 0.5 mg  in 1 mL
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 0.36 mg  in 1 mL
    TRIDECETH-6 (UNII: 3T5PCR2H0C) 0.24 mg  in 1 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) 0.16 mg  in 1 mL
    LYCIUM BARBARUM FRUIT (UNII: 930626MWDL) 0.06 mg  in 1 mL
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) 0.04 mg  in 1 mL
    SODIUM BENZOATE (UNII: OJ245FE5EU) 0.035 mg  in 1 mL
    LINALOOL, (+)- (UNII: F4VNO44C09) 0.01003 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-070-01500 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product06/10/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/06/2016
    Labeler - Casmara Cosmetics, SA (464973544)
    Registrant - Casmara Cosmetics, SA (464973544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Casmara Cosmetics, SA464973544manufacture(20151-070)