Label: TONYMOLY BCDATION MULTI USE SUN- octinoxate, homosalate, octisalate oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 17, 2017

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  • ACTIVE INGREDIENT

    Active ingredients: Ethylhexyl Methoxycinnamate 7.0%, Homosalate 6.0%, Ethylhexyl Salicylate 4.5%

  • INACTIVE INGREDIENT

    Inactive Ingredients: Caprylic/Capric Triglyceride, Octyldodecyl Myristate, Dimethicone, Phenyl Trimethicone, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Methyl Trimethicone, Glyceryl Caprylate, Fragrance, Caprylyl Glycol, Rosa Centifolia Flower Oil, Calendula Officinalis Flower Oil, Cocos Nucifera (Coconut) Oil, Rubus Idaeus (Raspberry) Seed Oil, Polyglyceryl-2 Triisostearate, Water, Methylpropanediol, Propanediol, Polyglyceryl-4 Caprate, Polyglyceryl-2 Dipolyhydroxystearate

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: For external use only. Avoid contact with eyes. Keep out of reach of children. Discontinue use if signs of irritation and/or rash appear. Do not use on - deep puncture wounds - animal bites - serious burns

  • DESCRIPTION

    Use: Helps prevent sunburn - if used as directed with other sun protection measures.

    Directions: Use at the last step of basic skin care every morning. Take an adequate amount with the pipette, apply on skin, and gently pat to promote absorption into skin.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    TONYMOLY BCDATION MULTI USE SUN 
    octinoxate, homosalate, octisalate oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-323
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.1 g  in 30 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate1.8 g  in 30 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.35 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Octyldodecyl Myristate (UNII: S013N99GR8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-323-021 in 1 CARTON01/03/2017
    1NDC:59078-323-0130 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/03/2017
    Labeler - TONYMOLY CO.,LTD (688216798)
    Registrant - TONYMOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONYMOLY CO.,LTD688216798repack(59078-323)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSON Co., Ltd._Osan Plant689847210manufacture(59078-323)
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