Label: SIERO CO AQUA CUSHION FOUNDATION 21 NATURAL BEIGE- titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 28, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide 9.0%, Ethylhexyl Methoxycinnamate 7.0%, Ethylhexyl Salicylate 4.8%, Octocrylene 2.0%, Zinc Oxide 2.0%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water,Cyclopentasiloxane,Cyclohexasiloxane,Glycerin,C12-15 Alkyl benzoate,PEG-30 Dipolyhydroxystearate, Butylene Glycol Dicaprylate/Dicaprate,Niacinamide,PEG-10 Dimethicone,CI 77492,Butylene Glycol,Quaternium-18 Bentonite,Sodium Chloride,Dimethicone,Copernicia Cerifera (Carnauba) Wax,Ozokerite,CI 77491,Chlorphenesin,Triethoxycaprylylsilane,Aluminum Hydroxide,Parfum,CI 77499,Adenosin,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,Rosa Damascena Flower Water,Nelumbo Nucifera Flower Extract,Calendula Officinalis Flower Extract,Angelica Archangelica Root Extract,Phenoxyethanol,Viola Tricolor Extract,Sodium Hyaluronate

  • PURPOSE

    Purpose: Sunscreen

  • 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

  • DESCRIPTION

    Uses: Moisture bomb cushion that gives a rich and moisturizing feeling providing skin moisture and radiance. It contains hyaluronic acid, lotus extract, calendula flower extract, pansy extract, angelica root extract, and damask rose flower water, replenishing moisture from the moment you apply providing healthy radiant skin.

    Directions: Apply a moderate amount to the puff and dab it over the entire face.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    SIERO CO AQUA CUSHION FOUNDATION 21 NATURAL BEIGE 
    titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71472-040
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.35 g  in 15 g
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.05 g  in 15 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.72 g  in 15 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene0.30 g  in 15 g
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.30 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71472-040-022 in 1 CARTON06/01/2017
    1NDC:71472-040-0115 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2017
    Labeler - JNG KOREA CO.,LTD. (557796103)
    Registrant - JNG KOREA CO.,LTD. (557796103)
    Establishment
    NameAddressID/FEIBusiness Operations
    JNG KOREA CO.,LTD.557796103relabel(71472-040)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(71472-040)