FDA.reportPublic FDA data

MIZON COLLAGENIC AQUA VOLUME UP LI P ESSENCE RENEWAL

Manufacturer
MIZON CO.,LTD. | Coson Co., Ltd._Osan Plant
Effective date
2018-07-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:27

Label at a glance#

ProductMIZON COLLAGENIC AQUA VOLUME UP LI P ESSENCE RENEWAL
Active ingredientMineral Oil, Octinoxate
Label structure8 sections

Indications and uses

Uses: Volume essence for moisturized and plump lips.

Dosage and administration

Directions: Apply on dry lips as often as needed.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

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

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

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

OTC - PURPOSE SECTION

Purpose: Skin Protectant, Sun protection

WARNINGS

WARNINGS SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

Uses

INDICATIONS & USAGE SECTION

Uses:

Volume essence for moisturized and plump lips.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions:

Apply on dry lips as often as needed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138809587520657GTIN-13: 8809587520657
EAN-13: 8809587520657
GTIN storage (14 digits): 08809587520657		lip carton.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57718-340-022022-01-28C16284748780-1d6a99b39-6916-a426-e053-dadaa90af4c2a1510c75-417e-46d6-bb7d-c9004760f614

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57718-340-01MIZON COLLAGENIC AQUA VOLUME UP LI P ESSENCE RENEWAL10 mL in 1 CONTAINERLIQUID101
57718-340-02MIZON COLLAGENIC AQUA VOLUME UP LI P ESSENCE RENEWAL1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57718-340MIZON COLLAGENIC AQUA VOLUME UP LI P ESSENCE RENEWAL (MINERAL OI L, OCTINOXATE) LIQUID [MIZON CO.,LTD.]1Legacy NDC, 2 package rows20180726_a1510c75-417e-46d6-bb7d-c9004760f614.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
57718-34057718-340-01, 57718-340-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
Mineral OilT5L8T28FGPACTIB
Octinoxate4Y5P7MUD51ACTIB
Butylene Glycol3XUS85K0RAIACT
1,2-HexanediolTR046Y3K1GIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4a7a4ee3-e783-4b72-ae82-600aa0f72defa1510c75-417e-46d6-bb7d-c9004760f6142018-07-26WarningsExact identifier
spl id: 4a7a4ee3-e783-4b72-ae82-600aa0f72def
spl set id: a1510c75-417e-46d6-bb7d-c9004760f614

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.