Label: MIZON COLLAGENIC AQUA VOLUME UP LI P ESSENCE RENEWAL- mineral oi l, octinoxate liquid

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated July 26, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: Mineral Oil 72.66%, Ethylhexyl Methoxycinnamate 4%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Polymethyl Methacrylate,Synt hetic Beeswax,Hydrogenated Styrene/Isoprene Copol ymer,Caprylic/Capric Triglyceride,Oenothera Biennis (Evening Primrose) Oil, Camellia Japonica Seed Oil, Limnanthes Alba (Meadow foam) Seed Oil,Olea Europ aea (Olive) Fruit Oil,Vitis Vinifera (Grape) Seed Oil,W ater,Camellia Sinensis Leaf Oil,Moringa Oleifera Seed Oil,Oryza Sativa (Rice) Bran Oil,Sesamum Indicum (Sesa me) Seed Oil,Cocos Nucife ra (Coconut) Oil,Glycine So ja (Soybean) Oil,Perilla Ocy moides Seed Oil,Vegetable Oil,Butylene Glycol,1,2-Hexanediol,Tocopherol,Phosp hatidylcholine,Hydrolyzed Collagen,Ceramide NP,Gly cine,Glutamic Acid,Serine,L ysine,Alanine,Arginine,Thre onine,Proline,Fragrance

  • PURPOSE

    Purpose: Skin Protectant, Sun protection

  • 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.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Uses

    Uses:

    Volume essence for moisturized and plump lips.

  • Directions

    Directions:

    Apply on dry lips as often as needed.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    MIZON COLLAGENIC AQUA VOLUME UP LI P ESSENCE RENEWAL 
    mineral oi l, octinoxate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-340
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Mineral Oil (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP) Mineral Oil7.26 g  in 10 mL
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.40 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    Butylene Glycol (UNII: 3XUS85K0RA)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57718-340-021 in 1 CARTON07/01/2018
    1NDC:57718-340-0110 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/01/2018
    Labeler - MIZON CO.,LTD. (694894201)
    Registrant - MIZON CO.,LTD. (694894201)
    Establishment
    NameAddressID/FEIBusiness Operations
    Coson Co., Ltd._Osan Plant689847210manufacture(57718-340)