Label: SIERO DOUBLE CO AQUA CC CUSHION 23 ROSY 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

If you are a consumer or patient please visit this version.

  • 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: Aloe Barbadensis Leaf Extract,Cyclopentasiloxane,Butylene Glycol, Cyclohexasiloxane,Glycerin,C12-15 Alkyl benzoate,PEG-30 Dipolyhydroxystearate, Butylene Glycol Dicaprylate/Dicaprate, Niacinamide,CI 77492,PEG-10 Dimethicone,Quaternium-18 Bentonite,Sodium Chloride,Dimethicone,Copernicia Cerifera (Carnauba) Wax,Ozokerite,CI 77491,Chlorphenesin,Triethoxycaprylylsilane,Aluminum Hydroxide,CI 77499,Phenoxyethanol,Parfum,Water,Adenosine,Camellia Japonica Seed Oil,Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer,Centella Asiatica Leaf Extract,Propylene Glycol,Camellia Sinensis Leaf Extract,Jasminum officinale (jasmine) Extract,Pseudoalteromonas Ferment Extract,1,2-Hexanediol,Xanthan gum,Chamomilla Recutita (Matricaria) Extract,Sodium Hyaluronate,Hibiscus Sabdariffa Flower Extract,Caprylyl glycol,Ethylhexylglycerin,Proline,Alanine,Serine,Sodium phosphate,Sodium hydroxide,Madecassoside

  • 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: CC cushion to help healthy skin expression through moist application and a tight fitting feeling. The more you dab, the more lightly it comes in close contact with the skin to naturally cover the flaws and blemishes. It contains aloe vera leaf extract, adding to the moisture content of the skin as soon as applied to hydrate the 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 DOUBLE CO AQUA CC CUSHION 23 ROSY BEIGE 
    titanium dioxide, octinoxate, octisalate, octocrylene, zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71472-080
    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
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71472-080-022 in 1 CARTON06/01/2017
    1NDC:71472-080-0115 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(71472-080)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hankook Cosmetics Manufacturing Co.,Ltd_Eumseong Factory688235645manufacture(71472-080)