Label: TAKO PORE SEBUM SUN- octocrylene, homosalate, octisalate, avobenzone, octinoxate stick

  • 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 April 4, 2018

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  • ACTIVE INGREDIENT

    Active ingredients: Octocrylene 5.00%, Homosalate 5.00%, Ethylhexyl Salicylate 4.50%, Butyl Methoxydibenzoylmethane 4.00%, Ethylhexyl Methoxycinnamate 3.50%

  • INACTIVE INGREDIENT

    Inactive ingredients:

    Dimethicone, Polyethylene, Ethylhexyl Palmitate, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Diphenylsiloxy Phenyl Trimethicone, Microcrystalline Wax, Polysilicone-15, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Fragrance, Tocopheryl Acetate, Caprylyl Glycol, Eclipta Prostrata Extract, Melia Azadirachta Leaf Extract, Moringa Oleifera Seed Oil, Water, Panthenol, Calamine, Nelumbo Nucifera Flower Water, Sea Water, Centella Asiatica Extract, 1,2-Hexanediol, Algae Extract, Chlorella Vulgaris Extract, Hizikia Fusiforme Extract, Hydrolyzed Collagen

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings:

    For external use only

    Avoid contact with eyes.

    Discontinue use if signs of irritation or rashes appear.

    Replace the cap after use.

    Keep Out of Reach of Children

  • DESCRIPTION

    Uses:

    - helps prevent sunburn

    - If used as directed with other sun protection measures

    Directions:

    Take an appropriate amount, evenly apply to face and body anywhere to be exposed to UV rays. Use as the last step of basic skin care.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    TAKO PORE SEBUM SUN 
    octocrylene, homosalate, octisalate, avobenzone, octinoxate stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59078-326
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene0.47 g  in 9.5 g
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate0.47 g  in 9.5 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.42 g  in 9.5 g
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone0.38 g  in 9.5 g
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate0.33 g  in 9.5 g
    Inactive Ingredients
    Ingredient NameStrength
    Dimethicone (UNII: 92RU3N3Y1O)  
    Ethylhexyl Palmitate (UNII: 2865993309)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59078-326-021 in 1 CARTON03/01/2018
    1NDC:59078-326-019.5 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35203/01/2018
    Labeler - TONY MOLY CO.,LTD (688216798)
    Registrant - TONY MOLY CO.,LTD (688216798)
    Establishment
    NameAddressID/FEIBusiness Operations
    TONY MOLY CO.,LTD688216798manufacture(59078-326)
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