MIZON SNAIL REPAIR INTENSIVE BB 21- octinoxate, titanium dioxide, 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.

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ACTIVE INGREDIENT

Active ingredients: Ethylhexyl Methoxycinnamate 7%, Titanium Dioxide 8.83%, Zinc Oxide 4.00%

INACTIVE INGREDIENT

Inactive ingredients:
Snail Secretion Filtrate, Cyclopentasiloxane, Glycerin, Diisostearyl Malate, Phenyl Trimethicone, Cyclohexasiloxane, Methyl Methacrylate Crosspolymer, PEG-10 Dimethicone, Niacinamide, Cyclomethicone, Sodium Chloride, Trimethylsiloxyphenyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Disteardimonium Hectorite, Sorbitan Sesquioleate, Polyethylene, Triethoxycaprylylsilane, Dimethicone Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Adenosine, Disodium EDTA, Iron Oxides (CI 77492), Iron Oxides (CI 77491), Iron Oxides (CI 77499), Phenoxyethanol

PURPOSE

Purpose: Sunscreen

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.

DESCRIPTION

Uses:

High coverage Snail Blemish Balm for brighter and more radiant skin. Helps prevent sunburn.

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 INTENSIVE BB 21 
octinoxate, titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57718-390
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.50 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide4.41 g  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.00 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin (UNII: PDC6A3C0OX)  
Diisostearyl Malate (UNII: QBS8A3XZGQ)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57718-390-021 in 1 CARTON12/01/2019
1NDC:57718-390-0150 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 finalpart35212/01/2019
Labeler - MIZON CO.,LTD. (694894201)
Registrant - PFD Co.,Ltd. (694522499)
Establishment
NameAddressID/FEIBusiness Operations
COSON Co., Ltd._Osan Plant689847210manufacture(57718-390)

Revised: 1/2020
Document Id: 5ffcb7b9-ce57-4e2b-9476-e504a01b03c0
Set id: b9a7bf86-4c96-4545-971e-8c6cd973c217
Version: 1
Effective Time: 20200120
 
MIZON CO.,LTD.