TONYMOLY MY SUNNY ALL SUNSPRAY- other skin care preparations spray 
Tonymoly 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.

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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

sun spray

TONYMOLY MY SUNNY ALL SUNSPRAY 
other skin care preparations spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-120
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE20557.8 mg  in 150 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4725 mg  in 150 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59078-120-011 in 1 CARTON01/19/2016
1150 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/14/2016
Labeler - Tonymoly Co., Ltd. (688216798)
Registrant - Tonymoly Co., Ltd. (688216798)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(59078-120)

Revised: 2/2016
Document Id: 2af68f0b-4b4d-5387-e054-00144ff8d46c
Set id: 29cc6b6a-f476-1234-e054-00144ff88e88
Version: 3
Effective Time: 20160204
 
Tonymoly Co., Ltd.