Label: TONYMOLY MY SUNNY WATERY SUN GEL- ethylhexyl methoxycinnamate gel

  • 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

If you are a consumer or patient please visit this version.

  • Active Ingredients

    Ethylhexyl Methoxycinnamate 6%

  • Purpose

    Sunscreen

  • Use

    This oil-free sun gel has a watery texture that applies softly and lightly to the skin, without leaving any sticky residue behind.

  • 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, CYCLOPENTASILOXANE, ETHYLHEXYL SALICYLATE, ISOAMYL P-METHOXYCINNAMATE, BUTYLENE GLYCOL, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, TRIETHANOLAMINE, GLYCERIN, DIPROPYLENE GLYCOL, PEG/PPG-30/10 DIMETHICONE, CARBOMER, CAPRYLYL GLYCOL, C12-13 PARETH-23, DIVINYLDIMETHICONE/DIMETHICONE COPOLYMER, BEHENYL ALCOHOL, CETETH-10, FRAGRANCE, PHENOXYETHANOL, POLYMETHYLSILSESQUIOXANE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALLANTOIN, CAPRYLHYDROXAMIC ACID, C12-13 PARETH-3, CHAMAECYPARIS OBTUSA LEAF EXTRACT, ORIGANUM VULGARE LEAF EXTRACT, SALIX ALBA (WILLOW) BARK EXTRACT, CINNAMOMUM CASSIA BARK EXTRACT, LACTOBACILLUS/SOYBEAN FERMENT EXTRACT, PORTULACA OLERACEA EXTRACT, SCUTELLARIA BAICALENSIS ROOT EXTRACT, NYMPHAEA ALBA FLOWER EXTRACT, ALOE BARBADENSIS LEAF JUICE, GLYCERYL POLYMETHACRYLATE, PROPYLENE GLYCOL, PLATINUM POWDER, POLYSORBATE 80

  • Principal Display Panel

    product

  • INGREDIENTS AND APPEARANCE
    TONYMOLY MY SUNNY WATERY SUN GEL 
    other skin care preparations gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-122
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN0.252 g  in 45 g
    Inactive Ingredients
    Ingredient NameStrength
    TROLAMINE (UNII: 9O3K93S3TK)  
    OREGANO (UNII: 0E5AT8T16U)  
    CHINESE CINNAMON (UNII: WS4CQ062KM)  
    NYMPHAEA ALBA FLOWER (UNII: 40KQ7Q535O)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    ALLANTOIN (UNII: 344S277G0Z)  
    C12-13 PARETH-23 (UNII: J1WW1510L4)  
    C12-13 PARETH-3 (UNII: DMC6N3419L)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CETETH-10 (UNII: LF9X1PN3XJ)  
    PEG/PPG-30/10 DIMETHICONE (UNII: J5JO20R8LH)  
    DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    AMILOXATE (UNII: 376KTP06K8)  
    CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)  
    OCTISALATE (UNII: 4X49Y0596W)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    WILLOW BARK (UNII: S883J9JDYX)  
    PORTULACA OLERACEA WHOLE (UNII: D5J3623SV2)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PLATINUM (UNII: 49DFR088MY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-122-011 in 1 CARTON01/19/2016
    145 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34601/14/2016
    Labeler - Tonymoly Co., Ltd. (688216798)
    Registrant - Tonymoly Co., Ltd. (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kolmar688732723manufacture(59078-122)