Label: SIERO CHEE CHEEK SUNNY ORANGE- dimethicone powder

  • 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 June 30, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: DIMETHICONE 1.90%

  • INACTIVE INGREDIENT

    Inactive ingredients: TALC, MICA, SILICA, NYLON-12, MAGNESIUM STEARATE, OCTYLDODECYL STEAROYL STEARATE, PHENYL TRIMETHICONE, TITANIUM DIOXIDE, DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER, BORON NITRIDE, CAPRYLIC/CAPRIC TRIGLYCERIDE, LAUROYL LYSINE, ETHYLENE/ACRYLIC ACID COPOLYMER, POLYMETHYL METHACRYLATE, IRON OXIDES(CI 77492), YELLOW 5 LAKE(CI 19140), METHICONE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, RED 6 (CI 15850), PHENOXYETHANOL, ALUMINUM MYRISTATE, IRON OXIDES(CI 77491), HYDROGENATED LECITHIN, SODIUM DEHYDROACETATE, TIN OXIDE, SAPPHIRE POWDER, AMETHYST POWDER, PEARL POWDER

  • PURPOSE

    Purpose: Skin Protectant

  • WARNINGS

    Warnings: - Keep away from direct sunlight and high temperature. - For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses: It is a blusher giving both cheeks natural color and bright radiance.

  • Directions

    Directions: Use the blush brush or cushion puff to dab into the apple zone (cheeks and under eye area).

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SIERO CHEE CHEEK SUNNY ORANGE 
    dimethicone powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71472-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE0.08 g  in 4.5 g
    Inactive Ingredients
    Ingredient NameStrength
    TALC (UNII: 7SEV7J4R1U)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71472-220-021 in 1 CARTON06/01/2017
    1NDC:71472-220-014.5 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34706/01/2017
    Labeler - JNG KOREA CO.,LTD. (557796103)
    Registrant - JNG KOREA CO.,LTD. (557796103)
    Establishment
    NameAddressID/FEIBusiness Operations
    JNG KOREA CO.,LTD.557796103relabel(71472-220)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar Korea Co., Ltd.689847167manufacture(71472-220)