MIZON COLLAGENIC AQUA VOLUME UP LI P ESSENCE RENEWAL- mineral oi l, octinoxate liquid 
MIZON CO.,LTD.

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.

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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

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)

Revised: 7/2018
Document Id: 4a7a4ee3-e783-4b72-ae82-600aa0f72def
Set id: a1510c75-417e-46d6-bb7d-c9004760f614
Version: 1
Effective Time: 20180726
 
MIZON CO.,LTD.