MIZON SNAIL REPAIR BLEMISH BALM ROSE BEIGE- titanium dioxide, octinoxate, zinc oxide cream 
MIZON CO.,LTD.

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.

----------

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

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)

Revised: 7/2018
Document Id: 91dfe51b-7efc-4272-acda-9a6dba3ccea9
Set id: aa20424f-f2b3-4b1a-8e8d-cf8b48eebc2f
Version: 1
Effective Time: 20180724
 
MIZON CO.,LTD.