Label: PUTTO SECRET UV FACE- titanium dioxide 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 August 26, 2013

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  • ACTIVE INGREDIENT

    titanium dioxide


  • INACTIVE INGREDIENT

    houttuynia cordata ext, glechoma hederacea flower/leaf/stem ext, plantago asiatica ext, cyclopentasiloxane, butylene glycol, crprylic/capric triglyceride, dipropylene glycol, zinc oxide, morus alba leaf ext, ulmus davidiana root ext, cyclomethicone, squalane, peg-10 dimethicone, cetyl peg/ppg-10/1 dimethicone, sodium chloride, dimethicone/vinyl dimethicone crosspolymer, dimethicone, stearalkonium hectorite, propylene carbonate, aluminum hydroxide, aluminum stearate, caprylhydroxamic acid, caprylyl glycol, glycerin, 1,2-hexanediol, tocopheryl acetate, betaine, panthenol, ceramide 3, distearyldimonium chloride, sodium hyaluronate, beta glucan, bentonite, fragrance


  • 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 UV FACE 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75885-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.6 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)  
    SQUALENE (UNII: 7QWM220FJH)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MORUS ALBA LEAF (UNII: M8YIA49Q2P)  
    ULMUS DAVIDIANA ROOT (UNII: URQ79U8261)  
    ALGELDRATE (UNII: 03J11K103C)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75885-030-0180 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/26/2013
    Labeler - AGABANG & COMPANY (687808766)
    Registrant - AGABANG & COMPANY (687808766)
    Establishment
    NameAddressID/FEIBusiness Operations
    AGABANG & COMPANY 687808766manufacture(75885-030)
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