Label: TOTAL PROTECTOR 30- zinc oxide,octinaxade,octisalate 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 July 5, 2011

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  • ACTIVE INGREDIENT

    Zinc Oxide - 7.8%
    Octinoxate - 7.5%
    Octisalate - 4.0%
  • PURPOSE

    Zinc Oxide - 7.8%  (Sunscreen)
    Octinoxate - 7.5%  (Sunscreen)
    Octisalate - 4.0%   (Sunscreen)
  • WHEN USING

    Provide the skin with maximum protection against the environmental factors that lead to premature skin aging.
  • PRINCIPAL DISPLAY PANEL

    sample
  • INGREDIENTS AND APPEARANCE
    TOTAL PROTECTOR 30 
    zinc oxide,octinaxade,octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-368
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide7.8 g  in 100 g
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.0 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    Diazolidinyl Urea (UNII: H5RIZ3MPW4)  
    Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Steareth-2 (UNII: V56DFE46J5)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    Steareth-100 (UNII: 4OH5W9UM87)  
    TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66078-368-17288 in 1 CASE
    13.24 g in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35212/13/2001
    Labeler - MD Formulation (087008363)
    Registrant - Harmony Labs, Inc. (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Harmony Labs, Inc.105803274manufacture, label, pack, relabel, repack
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