Label: MIZON SNAIL REPAIR BLEMISH BALM ROSE BEIGE- titanium dioxide, octinoxate, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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 July 24, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: Titanium Dioxide 8.02%, Ethylhexyl Methoxycinnamate 5.00%, Zinc Oxide 3.00%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Snail Secretion Filtrate,Cyclopen tasiloxane,Glycerin,Cyclohexasiloxane,CetylEthylhexanoate,PE G-10 Dimethicone,Phenyl Trime thicone,Niacinamide,Butylene Glycol Dicaprylate/Dicaprate,So dium Chloride,Ozokerite,Meth yl Methacrylate Crosspolymer, Disteardimonium Hectorite,Ce tyl PEG/PPG-10/1Dimethicone, Water,Tocopheryl Acetate,Allan toin,Panthenol,Boron Nitride,Ac rylates/Ammonium Methacrylate Copolymer,C12-15 Alkyl Benzoa te,Alcohol,Castanea Sativa (Ches tnut) Seed Extract,Propylene Gly col,Butylene Glycol,1,2-Hexaned iol,Lecithin,Caprylic/Capric Trigly ceride,Gentiana Lutea Root Extr act,Achillea Millefolium Extract,A rtemisia Absinthium Extract,Arni ca Montana Flower Extract,Diiso propyl Adipate,Lavandula Angusti folia (Lavender) Extract,Rosmarin us Officinalis (Rosemary) Leaf Ex tract,Thymus Vulgaris (Thyme) E xtract,Origanum Vulgare Leaf Ext ract,Ubiquinone,Carica Papaya (P apaya) Fruit Water,Sodium Hyalu ronate,Beta-Glucan,Vaccinium Ma crocarpon (Cranberry) Fruit Ex tract,Rubus Idaeus (Raspberry) Fruit Extract,Prunus Serotina (W ild Cherry) Fruit Extract,Cornus Officinalis Fruit Extract,Punica Gr anatum Fruit Extract,Potassium Sorbate,Triethyl Citrate,Caprylyl Methicone,Iron Oxides (CI 77492), Phenoxyethanol,Sorbitan Sesquio leate,Triethoxycaprylylsilane,Iron Oxides (CI 77491),Aluminum Hy droxide,Iron Oxides (CI 77499), Ethylhexylglycerin,Isotridecyl Ison onanoate,Adenosine,Disodium ED TA,Fragrance

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    [PRECAUTIONS]

    1)In case of swell ing, redness, itching or any severe al lergic reactions while using the prod uct, 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 f rom direct sunlight.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • DESCRIPTION

    Uses:

    This high performance, multi-functio nal BB cream is concentrated with 45% snail extract to help improve the con dition of damaged skin. Snail extract’s anti-inflammatory and healing properties promote the reduction of blemishes and encourage skin renewal.

    Directions:

    Take moderate amount and apply evenly over entire face at the last step in skin care

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MIZON SNAIL REPAIR BLEMISH BALM ROSE BEIGE 
    titanium dioxide, octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide4.01 g  in 50 mL
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.50 g  in 50 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION1.50 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    Glycerin (UNII: PDC6A3C0OX)  
    Phenyl Trimethicone (UNII: DR0K5NOJ4R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57718-250-021 in 1 CARTON07/01/2018
    1NDC:57718-250-0150 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 - MIZON CO.,LTD. (694894201)
    Registrant - MIZON CO.,LTD. (694894201)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coson Co., Ltd._Osan Plant689847210manufacture(57718-250)