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

MIZON COLLAGENIC AQUA VOLUME UP LI P ESSENCE RENEWAL by

Drug Labeling and Warnings

MIZON COLLAGENIC AQUA VOLUME UP LI P ESSENCE RENEWAL by is a Otc medication manufactured, distributed, or labeled by MIZON CO.,LTD., Coson Co., Ltd._Osan Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57718-340
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Mineral Oil (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	Mineral Oil	7.26 g  in 10 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	0.40 g  in 10 mL

Inactive Ingredients
Ingredient Name	Strength
Butylene Glycol (UNII: 3XUS85K0RA)
1,2-Hexanediol (UNII: TR046Y3K1G)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57718-340-02	1 in 1 CARTON	07/01/2018
1	NDC: 57718-340-01	10 mL in 1 CONTAINER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/01/2018

Labeler - MIZON CO.,LTD. (694894201)

Registrant - MIZON CO.,LTD. (694894201)

Establishment
Name	Address	ID/FEI	Business Operations
Coson Co., Ltd._Osan Plant		689847210	manufacture(57718-340)