Label: SUNBLOCK- titanium dioxide lotion

  • 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 July 1, 2010

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  • ACTIVE INGREDIENT

    Active Ingredients:                        Purpose

    Titanium Dioxide 8%                        Sunscreen
    Octyl Methoxycinnamate 6%         Sunscreen


    Other Ingredients: Purified Water (Acqua), Capryic/Capic Triglyceride, C12-15 Alkyl Benzoate, Glycerin, Cetyl Alcohol, Stearyl Alcohol, Isopropyl Myristate, Propylene Glycol, Ceteareth-6,Ceteareth-25, Dimethocone, Glyceryl Stearate, Stearic Acid, Tocopherol Acetate(Vitamin E), Alpha Bisabolol, Triethanolamine, Diazolidinyl Urea, Methylparaben, Propylparaben, Allantoin, BHT.
  • PRINCIPAL DISPLAY PANEL

    Vienna Health and Beauty - by Minh Le, M.D. SUNBLOCK - UVA/UVB Protection - SPF30image of carton for tub

  • INGREDIENTS AND APPEARANCE
    SUNBLOCK 
    titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52625-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6 g  in 80 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 80 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52625-101-021 in 1 CARTON
    1NDC:52625-101-0180 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35207/01/2010
    Labeler - Vienna Health and Beauty Corporation (831463919)
    Registrant - Vienna Health and Beauty Corporation (831463919)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vienna Health and Beauty Corporation831463919manufacture
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