Label: TONYMOLY MY SUNNY ALL SUNSPRAY- ethylhexyl methoxycinnamate spray

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated February 4, 2016

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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

  • INGREDIENTS AND APPEARANCE
    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)