TONYMOLY MY SUNNY ALL SUNSPRAY- ethylhexyl methoxycinnamate spray

TONYMOLY My Sunny All SunSpray by

Drug Labeling and Warnings

TONYMOLY My Sunny All SunSpray by is a Otc medication manufactured, distributed, or labeled by Tonymoly Co., Ltd., Cosmax, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Ethylhexyl Methoxycinnamate 7.30%, Octocrylene 3.00%, Titanium Dioxide 3.24%, Zinc Oxide 4.32%

Purpose

Skin Protectant

Use

Sunscreen

Caution

For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear.

Keep out of reach of children

Keep out of reach of children.

Directions

After fully shaking the bottle, spray for 2-3 seconds from a distance of 20 cm on skin areas exposed to UV rays.

Inactive Ingredients

Water, Cyclopentasiloxane, Cyclohexasiloxane, Alcohol Denat., Butylene Glycol, Methyl Methacrylate Crosspolymer, Ethylhexyl Palmitate, PEG-10 Dimethicone, Silica, Neopentyl Glycol Diheptanoate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylyl Methicone, Aluminum Hydroxide, Glyceryl Caprylate, Stearic Acid, Disteardimonium Hectorite, Fragrance(Parfum), Dimethicone/Methicone Copolymer, Caprylyl Glycol, Disodium EDTA, Water, Phenoxyethanol, Prunus Mume Fruit Water, Nymphaea Alba Flower Extract, Aloe Barbadensis Leaf Extract, 1,2-Hexanediol, Origanum Vulgare Leaf Extract, Salix Alba (Willow) Bark Extract, Chamaecyparis Obtusa Leaf Extract, Ethylhexylglycerin, Portulaca Oleracea Extract, Cinnamomum Cassia Bark Extract, Scutellaria Baicalensis Root Extract, Lactobacillus/Soybean Ferment Extract, Polymethylsilsesquioxane, Platinum Powder

Principal Display Panel

INGREDIENTS AND APPEARANCE

TONYMOLY MY SUNNY ALL SUNSPRAY 
other skin care preparations spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59078-120
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	20557.8 mg  in 150 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4725 mg  in 150 mL

Inactive Ingredients
Ingredient Name	Strength
BEMOTRIZINOL (UNII: PWZ1720CBH)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)
CHINESE CINNAMON (UNII: WS4CQ062KM)
NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)
OREGANO (UNII: 0E5AT8T16U)
WILLOW BARK (UNII: S883J9JDYX)
PLATINUM (UNII: 49DFR088MY)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
WATER (UNII: 059QF0KO0R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALCOHOL (UNII: 3K9958V90M)
PRUNUS MUME FRUIT (UNII: 639190I8CU)
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59078-120-01	1 in 1 CARTON	01/19/2016
1		150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/14/2016

Labeler - Tonymoly Co., Ltd. (688216798)

Registrant - Tonymoly Co., Ltd. (688216798)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(59078-120)