MIZON SNAIL REPAIR INTENSIVE BB 21- octinoxate, titanium dioxide, zinc oxide cream

MIZON SNAIL REPAIR INTENSIVE BB 21 by

Drug Labeling and Warnings

MIZON SNAIL REPAIR INTENSIVE BB 21 by is a Otc medication manufactured, distributed, or labeled by MIZON CO.,LTD., PFD Co.,Ltd., COSON Co., Ltd._Osan Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

MIZON SNAIL REPAIR INTENSIVE BB 21 
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57718-390
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.50 g  in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	4.41 g  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.00 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
Glycerin (UNII: PDC6A3C0OX)
Diisostearyl Malate (UNII: QBS8A3XZGQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57718-390-02	1 in 1 CARTON	12/01/2019
1	NDC: 57718-390-01	50 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
OTC monograph not final	part352	12/01/2019

Labeler - MIZON CO.,LTD. (694894201)

Registrant - PFD Co.,Ltd. (694522499)

Establishment
Name	Address	ID/FEI	Business Operations
COSON Co., Ltd._Osan Plant		689847210	manufacture(57718-390)