MIZON SNAIL REPAIR INTENSIVE BB 31- octinoxate, titanium dioxide, zinc oxide cream

MIZON SNAIL REPAIR INTENSIVE BB 31 by

Drug Labeling and Warnings

MIZON SNAIL REPAIR INTENSIVE BB 31 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: Ethylhexyl Methoxycinnamate 7%, Titanium Dioxide 9.25%, Zinc Oxide 4.08%

INACTIVE INGREDIENT

Inactive ingredients:

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

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:

MIZON SNAIL REPAIR INTENSIVE BB CREAM SPF50+ PA+++(Paraben Free, No fragrance)

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 31 
octinoxate, titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57718-370
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	4.62 g  in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.04 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: 57718-370-02	1 in 1 CARTON	07/01/2018
1	NDC: 57718-370-01	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	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(57718-370)