Label: ISLEAF SATIN LIP AND CHEEK DUO BERRY RED- 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 August 8, 2017

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  • ACTIVE INGREDIENT

    dimethicone

  • INACTIVE INGREDIENT

    wter butylene glycol, beeswax, etc

  • PURPOSE

    for a gradient effect

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children

  • INDICATIONS & USAGE

    For a gradient effect, apply only at the center and use the side of the cushion applicator to smudge the color outward to the corners of your mouth.

    For cheeks, dot on cheeks and lightly smooth dotting by fingertip or applicator

  • WARNINGS

    1. If the following symptoms occur after product use, stop using the product immediately and consult a dermatologist (continuous use can exacerbate the symptoms).
    1) Occurrence of red spots, swelling, itchiness, and other skin irritation
    2) If the symptoms above occur after the application area is exposed to direct sunlight
    2. Do not use on open wounds, eczema, and other skin irritations
    3. Precaution for Storage and Handling
    1) Close the lid after use
    2) Keep out of reach of infants and children
    3) Do not to store in a place with high/low temperature and exposed to direct sunlight

    4. Use as avoiding eye areas.

  • DOSAGE & ADMINISTRATION

    for external use only

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ISLEAF SATIN LIP AND CHEEK DUO BERRY RED 
    dimethicone liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70818-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.15 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70818-004-014.5 g in 1 APPLICATOR; Type 0: Not a Combination Product08/08/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/08/2017
    Labeler - C3 Co., Ltd. (689846633)
    Registrant - C3 Co., Ltd. (689846633)
    Establishment
    NameAddressID/FEIBusiness Operations
    C3 Co., Ltd.689846633label(70818-004) , manufacture(70818-004) , pack(70818-004)
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