MIZON UV SUN PROTECTOR- octinoxate, octisalate, zinc oxide, titanium dioxide 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 Ingredient: Ethylhexyl Methoxycinnamate 7.35%, Ethylhexyl Salicylate 4.75%, Zinc Oxide 4.30%, Titanium Dioxide 3.60%

INACTIVE INGREDIENT

Inactive Ingredients: Water, Cyclopentasiloxane, Cyclohexasiloxane, Butylene Glycol, Lauryl Peg-9 Polydimethylsiloxyethyl Dimethicone, Dimethicone, Silica, Dimethicone/Vinyl Dimethicone Crosspolymer, Triethyl Citrate, Sodium Chloride, DIMETHICONE/PEG-10/15 CROSSPOLYMER, Triethoxycaprylylsilane, Sodium Hyaluronate, Biosaccharide Gum-1, Hedera Helix(Ivy) Extract, Ethylhexylglycerin, Caprylyl Glycol, Disteardimonium Hectorite, Brassica Oleracea Italica(Broccoli) Extract, Fragrance, Allantoin, Sodium Citrate, Tropolone, Argania Spinosa Kernel Oil, Dipropylene Glycol, Disodium Edta, Tocopherol

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itching, irritation, or symptoms where product has been applied under direct sunlight. 2. Do not use on scarred skin or if you have dermatitis or eczema. 3. Keep the cap closed on this product. 4. Keep away from direct sunlight or heat. 5. Keep out of reach of children.

DESCRIPTION

How to use: Apply evenly to areas exposed to UV Rays such as your face and arms and allow it to absorb.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of carton

MIZON UV SUN PROTECTOR
octinoxate, octisalate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57718-070
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	3.67 g in 50 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	2.37 g in 50 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.15 g in 50 mL
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	1.80 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:57718-070-01	50 mL in 1 CARTON; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/01/2015

Labeler - MIZON CO., LTD. (557815570)

Registrant - MIZON CO., LTD. (557815570)

Name	Address	ID/FEI	Business Operations
Establishment
MIZON CO., LTD.		557815570	repack(57718-070)

Name	Address	ID/FEI	Business Operations
Establishment
Coson Co., Ltd.		689835593	manufacture(57718-070)