Label: CLEANSER DERMOPURIFYING OILY SKIN- 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 with massage, leave for two minutes and rinse.

  • DOSAGE & ADMINISTRATION

    . apply with massage, leave for two minutes and rinse

  • Uses

    . removes excess oil and dirty without drying

  • INACTIVE INGREDIENT

    water, capryl glucoside, sodium polyacrylate, capryloyl glycine, triethanolamine sulfate, ammonium acryloydimethyl taurate/VP copolymer, butylene glycol, cyclopentasiloxane, trideceth-6, salicylic acid, fragrance, PEG/PPG-18/18 dimethicone, portulaca oleracea extract.

  • PURPOSE

    . removes excess oil and dirty without drying.

  • Active Ingredients

    Dimethicone 1.52%.....................Skin Protectant

    Bottle

  • PRINCIPAL DISPLAY PANEL

    Cleanser Dermopurifying Oily skin

    Skin protectant

    Shinestop Dermopurifying Cleanser

    Facial Collection

    Box

  • INGREDIENTS AND APPEARANCE
    CLEANSER DERMOPURIFYING OILY SKIN 
    dimethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-073
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE1.52 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CAPRYLYL GLUCOSIDE (UNII: V109WUT6RL) 6 mg  in 1 mL
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4) 1 mg  in 1 mL
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.9 mg  in 1 mL
    PORTULACA OLERACEA SEED (UNII: M08917G08Z) 0.012 mg  in 1 mL
    SALICYLIC ACID (UNII: O414PZ4LPZ) 0.2 mg  in 1 mL
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ) 2 mg  in 1 mL
    TRIETHANOLAMINE SULFATE (UNII: MV1V89M17O) 1.4 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 83.5 mg  in 1 mL
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg  in 1 mL
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L) 2.08 mg  in 1 mL
    PERFLUNAFENE (UNII: 54A06VV62N) 0.1 mg  in 1 mL
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 0.72 mg  in 1 mL
    TRIDECETH-6 (UNII: 3T5PCR2H0C) 0.48 mg  in 1 mL
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) 0.08 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-073-021 in 1 BOTTLE, DISPENSING06/10/2016
    1NDC:20151-073-01150 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 finalpart34706/06/2016
    Labeler - Casmara Cosmetics, SA (464973544)
    Registrant - Casmara Cosmetics, SA (464973544)
    Establishment
    NameAddressID/FEIBusiness Operations
    Casmara Cosmetics, SA464973544manufacture(20151-073)