Label: TONYMOLY MY SUNNY ALL IN ONE SUN SPF45- ethylhexyl methoxycinnamate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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 7.50%, Glycerin 6.47%, Octocrylene 2.00%, Titanium Dioxide 4.25%

  • Purpose

    Sunscreen

  • Use

    The all-in-one sun helps restore natural tone by providing moisture to the skin.

  • 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

    During the last step of basic skin care, dispense an appropriate amount and evenly apply to any skin that will be exposed to ultraviolet sunlight.

  • Inactive Ingredients

    Water, Ethylhexyl Palmitate, Cyclopentasiloxane, 4-Methylbenzylidene Camphor, Butyl Methoxydibenzoylmethane, Cyclohexasiloxane, Butylene Glycol, Neopentyl Glycol Diheptanoate, Ethylhexyl Salicylate, Polymethyl Methacrylate, Cetearyl Alcohol, Glyceryl Stearate, PEG-100 Stearate, Triceteareth-4 Phosphate, Glycol Stearate, Silica, Sorbitan Sesquioleate, Potassium Cetyl Phosphate, PEG-2 Stearate, Tromethamine, Phenoxyethanol, Glyceryl Caprylate, Fragrance(Parfum), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates Copolymer, Caprylyl Glycol, Dimethicone, Iron Oxides (CI 77492), Disodium EDTA, Iron Oxides (CI 77491), Aloe Barbadensis Leaf Juice, Lavandula Angustifolia (Lavender) Water, Anthemis Nobilis Flower Water, Polydecene, Dipropylene Glycol, Prunus Mume Fruit Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Sodium Palmitoyl Proline, Codium Tomentosum Extract, Enteromorpha Compressa Extract, Macrocystis Pyrifera (Kelp) Extract, Ecklonia Cava Extract, Gelidium Cartilagineum Extract, Laminaria Japonica Extract, Nymphaea Alba Flower Extract, Squalane, Chamaecyparis Obtusa Leaf Extract, Viscum Album (Mistletoe) Fruit Extract, Coco-Glucoside, Vanilla Tahitensis Fruit Extract, Benzyl Alcohol, Sansevieria Trifasciata Leaf Extract, Portulaca Oleracea Extract, Sorbic Acid, Ethylhexylglycerin, Potassium Sorbate, Dehydroacetic Acid, Sodium Benzoate

  • Principal Display Panel

    sunblock

  • INGREDIENTS AND APPEARANCE
    TONYMOLY MY SUNNY ALL IN ONE SUN SPF45 
    other skin care preparations cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-125
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE17977.5 mg  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN8145.73 mg  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2100 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    PRUNUS MUME FRUIT (UNII: 639190I8CU)  
    GELIDIUM CARTILAGINEUM (UNII: 37LBZ0E1UE)  
    SQUALANE (UNII: GW89575KF9)  
    PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
    ENZACAMENE (UNII: 8I3XWY40L9)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ORANGE (UNII: 5EVU04N5QU)  
    OCTISALATE (UNII: 4X49Y0596W)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)  
    ULVA COMPRESSA (UNII: SXZ209FM33)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    VANILLA (UNII: Q74T35078H)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    MACROCYSTIS PYRIFERA (UNII: K31S3OG5C4)  
    ECKLONIA CAVA (UNII: UXX2N5V39P)  
    LAMINARIA JAPONICA (UNII: WE98HW412B)  
    NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
    VISCUM ALBUM FRUIT (UNII: P83EQ521R3)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)  
    SANSEVIERIA TRIFASCIATA LEAF (UNII: S3B72UOI9O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ACETYL TETRAPEPTIDE-15 (UNII: 6K389LE0MV)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PEG-2 STEARATE (UNII: 94YQ11Y95F)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    SODIUM PALMITOYL PROLINE (UNII: 64L053FRFO)  
    CODIUM TOMENTOSUM (UNII: B8B45BRU87)  
    SORBIC ACID (UNII: X045WJ989B)  
    VISCUM ALBUM WHOLE (UNII: E6839Q6DO1)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-125-011 in 1 CARTON01/19/2016
    1100 mL in 1 TUBE; 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
    Cosmax689049693manufacture(59078-125)