UV BOUNCE MIST- octinoxate, octisalate spray

UV BOUNCE MIST by

Drug Labeling and Warnings

UV BOUNCE MIST by is a Otc medication manufactured, distributed, or labeled by MIZON CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Ethylhexyl Methoxycinnamate 7%, Ethylhexyl Salicylate 4%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Butylene Glycol, Caprylic/Capric Triglyceride, Phenylbenzimidazole Sulfonic Acid, Disiloxane, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Ceteareth-6 Olivate, Niacinamide, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Tromethamine, Dimethicone, Tocopheryl Acetate, Benzyl Alcohol, Microcrystalline Cellulose, Fragrance, Portulaca Oleracea Extract, Phenoxyethanol, Sodium Benzoate, Disodium EDTA, Potassium Sorbate, Glycerin, Cetearyl Olivate, Sorbitan Olivate, Adenosine, Cellulose Gum, Alpinia Officinarum Root Extract, Lactobacillus/Nelumbo Nucifera Seed Ferment Filtrate, Citrullus Lanatus (Watermelon) Fruit Extract, Terminalia Chebula Fruit Extract, Abies Koreana Leaf Extract, Aloe Barbadensis Leaf Juice

PURPOSE

Purpose: UVA/UVB Protection

WARNINGS

Warnings:
1. If following symptoms occur, stop use and consult a doctor: red spots, swelling, itcihng, irritation, or symtoms on applied skin under direct sunlight.
2. Do not use on scarred skin, or if you have dermatitis or eczema
3. Keep the cap close on its product
4. Keep away from direct sunlight or heat.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:
Keep out of reach of babies and children

INDICATIONS AND USAGE

Indication and Usage:
Spray onto areas exposed to UV rays from about 20-30cm aways. (Use before or after makeup.)

DOSAGE AND ADMINISTRATION

Dosage and Administration:
2-3 time spry onto the areas that exposed to UV rays, and tap on applied skin for better aborption.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UV BOUNCE MIST 
octinoxate, octisalate spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57718-030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.5 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2 mg  in 50 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57718-030-01	50 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	03/01/2014

Labeler - MIZON CO., LTD. (557815570)

Registrant - MIZON CO., LTD. (557815570)

Establishment
Name	Address	ID/FEI	Business Operations
MIZON CO., LTD.		557815570	manufacture(57718-030)