Label: PUTTO ATO SECRET UV FACE SPF 6- zinc oxide 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 February 17, 2011

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  • ACTIVE INGREDIENT

    Active Ingredients: ZINC OXIDE, TITANIUM DIOXIDE

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    HOUTTUYNIA CORDATA EXTRACT, PLANTAGO ASIATICA EXTRACT, GLECHOMA HEDERACEA FLOWER/LEAF/STEM EXTRACT, MORUS ALBA LEAF EXTRACT, ULMUS DAVIDIANA ROOT EXTRACT, CYCLOPENTASILOXANE, SQUALANE, PEG-10 DIMETHICONE, METHICONE COPOLYMER, DIPROPYLENE GLYCOL, BUTYLENE GLYCOL, VINYL DIMETHICONE CROSSPOLYMER, DIMETHICONE, ALUMINUM HYDROXIDE, STEARIC ACID, SODIUM CHLORIDE, BETAINE, DISTEARYLDIMONIUM CHLORIDE, BENTONITE, CAPRYLYL GLYCOL, CAPRYLHYDROXAMIC ACID, GLYCERIN, BETA-GLUCAN, PANTHENOL, TOCOPHERYL ACETATE, FRAGRANCE, CERAMIDE 3

  • DESCRIPTION

    Directions:
    It is good to use within 3minute after bath and use it like you are massaging the skin if the child scratches or on a dry day.

    Caution:
    For external use only.
    Use only as directed.
    Do not apply to sensitive skin.
    Keep out of reach of children.
    Store in a cool. dry place.

  • PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    PUTTO ATO SECRET UV FACE  SPF 6
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75885-010
    Route of AdministrationCUTANEOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC OXIDE2.70 mL  in 80 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE1.34 mL  in 80 mL
    Inactive Ingredients
    Ingredient NameStrength
    PLANTAGO MAJOR (UNII: W2469WNO6U)  
    GLECHOMA HEDERACEA (UNII: L6O7WQK912)  
    SQUALANE (UNII: GW89575KF9)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75885-010-0180 mL in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2010
    Labeler - AGABANG & COMPANY (687808766)
    Registrant - AGABANG & COMPANY (687808766)
    Establishment
    NameAddressID/FEIBusiness Operations
    AGABANG & COMPANY687808766manufacture
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