Label: VILLAGE11FACTORY PINK CALMING SUN BLOCK- zinc oxide cream

  • 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 August 7, 2018

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

  • ACTIVE INGREDIENT

    Active ingredients: Zinc Oxide 12%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Water,Cyclopentasiloxane,Dimethicone,Propanediol,Titanium Dioxide (CI 77891),Phenyl Trimethicone, Calamine, PEG-10Dimethicone, Niacinamide,1,2-Hexanediol, Disteardimonium Hectorite,Magnesium Sulfate,Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, Hydrogen Dimethicone, Aluminum Hydroxide, Cetearyl Dimethicone Crosspolymer, Stearic Acid, Sorbitan Sesquioleate, Fructooligosaccharides, Saccharide Hydrolysate, Pullulan, Ethylhexylglycerin, Octyldodecanol,Adenosine, Butylene Glycol, Echium Plantagineum Seed Oil,Calendula Officinalis Flower Extract, Camellia Sinensis Leaf Extract,Cardiospermum Halicacabum Flower/ Leaf/Vine Extract, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Polyglyceryl-2Dipolyhydroxystearate, Cyclomethicone, C12-15 Alkyl Benzoate, Tocopherol, Dimethicone Crosspolymer, Polyglyceryl-2 Caprate,Aluminum Stearate, Polyhydroxystearic Acid, Alumina, Sucrose Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, GlycerylCaprylate, Squalane, Fragrance

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    1) In case of swelling, redness, itching or any severe allergic reactions while using the product, discontinue use and consult with a specialist.

    2) Do not apply on broken skin or wounded areas.

    3) Precautions for storage and handling A) Keep out of reach of children. B) Store away from direct sunlight.

    4) For external use only

  • DESCRIPTION

    Uses:

    Containing the UV suncare secret of Village 11 factory, this calming tone up sun block protects the skin from UV rays and external harm. Also, it helps to prevent sunburn.

    Directions:

    For the last step of your skin care, apply an appropriate amount onto areas of your skin that is exposed to sunlight.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    VILLAGE11FACTORY PINK CALMING SUN BLOCK 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72470-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.00 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72470-030-021 in 1 CARTON07/01/2018
    1NDC:72470-030-0150 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/01/2018
    Labeler - PFD Co.,Ltd. (694522499)
    Registrant - PFD Co.,Ltd. (694522499)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coson Co., Ltd._Osan Plant689847210manufacture(72470-030)