Label: PUTTO SECRET SUN SCREEN- titanium dioxide cream

  • 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 July 13, 2013

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  • ACTIVE INGREDIENT

    titanium dioxide


  • INACTIVE INGREDIENT

    Cyclopentasiloxane, Glechoma Hederacea Flower/Leaf/Stem Extract, Houttuynia Cordata Extract,  Plantago Asiatica Extract, Cetearyl Alcohol, Ethylhexyl Methoxycinnamate, Propanediol, Dipropylene Glycol, Glycerin, Morus Alba Leaf Extract, Ulmus Davidiana Root Extract, Butylene Glycol, Octocrylene, Polysorbate 60, Polyglyceryl-3 Methylglucose Distearate,  1,2-Hexanediol,  Alumina,  Betaine,  Hexyl Laurate,  Methicone,  PEG-10 Dimethicone,  Sorbitan Olivate,  Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine,  Glyceryl Stearate,  PEG-100 Stearate,  Fragrance, Magnesium Aluminum Silicate,  Caprylhydroxamic Acid,  Caprylyl Glycol,  Panthenol,  Triethanolamine,  Xanthan Gum,  Disodium EDTA,  Hydroxyethylcellulose,  Tocopheryl Acetate,  Beta-Glucan,  Butyrospermum Parkii (Shea Butter),  Ceramide 3, Squalane     　     



  • PURPOSE

    sun screen


  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of the children


  • INDICATIONS & USAGE

    gently spread a fair amount over face, neck, arm and etc esposed to UV rays


  • WARNINGS

    do not apply to sensitive skin
    store in a cool, dry place


  • DOSAGE & ADMINISTRATION

    for external use only


  • PRINCIPAL DISPLAY PANEL

    package insert
  • INGREDIENTS AND APPEARANCE
    PUTTO SECRET SUN SCREEN 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75885-020
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLECHOMA HEDERACEA FLOWERING TOP (UNII: 2458J91U39)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    PLANTAGO ASIATICA (UNII: 5F5728J5E8)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORUS ALBA LEAF (UNII: M8YIA49Q2P)  
    ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    OCTOCRYLENE (UNII: 5A68WGF6WM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75885-020-0165 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/13/2013
    Labeler - AGABANG & COMPANY (687808766)
    Registrant - AGABANG & COMPANY (687808766)
    Establishment
    NameAddressID/FEIBusiness Operations
    AGABANG & COMPANY 687808766manufacture(75885-020)
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