Label: SHINE CONTROL SEBUM REGULATING GEL- glycerin gel

  • 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 26, 2017

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  • Active Ingredients Purpose

    Active Ingredients Purpose

    Glycerin 8%.................... Skin Protectant

    Bottle

  • Uses

    . facial treatment that regulates the oil secretion

  • Uses

    . facial treatment that regulates the oil secretion

  • 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 to clean face and neck until the product has been absorbed

    . can be used in the morning and/or night

  • Other information

    . keep the product in a cool and dry place.

  • Inactive ingredients

    Water, Butylene glycol dicaprylate/dicaprate, Ammonium acryloyl dimethyltaurate/VP copolymer, Potassium azeloyl diglycinate, Phenoxyethanol, Fragrance, Lactic acid, Ethylhexylglycerin, Tetrasodium glutamate diacetate

  • Directions

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

    . can be used in the morning and/or night

  • Shine Control

    Shine control
    Sebum Regulating Gel

    Oily Blemish Prone Skin

    Box

  • INGREDIENTS AND APPEARANCE
    SHINE CONTROL SEBUM REGULATING GEL 
    glycerin gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:20151-095
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN5 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY) 0.094 mg  in 1 mL
    POTASSIUM AZELOYL DIGLYCINATE (UNII: N02RVN6NYP) 1.8 mg  in 1 mL
    WATER (UNII: 059QF0KO0R) 86.81 mg  in 1 mL
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) 2 mg  in 1 mL
    LACTIC ACID (UNII: 33X04XA5AT) 0.14 mg  in 1 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.1 mg  in 1 mL
    BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE (UNII: 75D21FL1PI) 3 mg  in 1 mL
    PHENOXYETHANOL (UNII: HIE492ZZ3T) 0.9 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:20151-095-021 in 1 BOTTLE, PLASTIC02/26/2017
    1NDC:20151-095-0150 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 finalpart34702/25/2017
    Labeler - CASMARA COSMETICS, SA (464973544)
    Registrant - CASMARA COSMETICS, SA (464973544)
    Establishment
    NameAddressID/FEIBusiness Operations
    CASMARA COSMETICS, SA464973544manufacture(20151-095)
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