Label: TOTAL PROTRECTOR 15- octinoxate, zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 31, 2012

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  • ACTIVE INGREDIENT

    Octinoxate - 7.5%             Sunscreen
    Zink Oxide - 4.9%             Sunscreen
  • INDICATIONS & USAGE

    When using this product do not use in or near the eyes.If product gets into eyes, rlnse thoroughly with water.
  • WARNINGS

    Warnings: For external use only.
  • STOP USE

    Stop use and ask a doctor if Irritation or rash appears and lasls.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed , get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions: Children under 2 years of age should use sunscreen products with a minimum SPF of 4.
    Adult and children 6 months and over: apply liberally 15 minutes before sun or water exposure; reapply after swimming or excessive sweating or anytime after towel drying . Children under 6 months ask a doctor.
  • SPL UNCLASSIFIED SECTION

    Other information store at 20.25C (68-770 F)
    Sun Alert: The sun causes sun damage. Regular use of sunscreens over the years may reduce the chance of skIn damage, some types of skin cancer, and other harmful effects due to the sun.
  • INACTIVE INGREDIENT

    Inactive ingredients: Water (Aqua), Glyceryl Stearate, C12-15 Alkyl Benzoate, GlycerIn, Steareth-2, Steareth-100, Tricontanyl PVP, PEG-100 Stearate, Tocopheryl Acetate, Allantoin, Xanthan Gum, Cetyl Hydroxyelhylcellulose, Dimethicone, Disodium EDTA, Diazolidinyl Urea, lodopropynyl Butylcarbamate, Methylparaben. Propylparaben.
  • PRINCIPAL DISPLAY PANEL

    Label
    U Carton
  • INGREDIENTS AND APPEARANCE
    TOTAL PROTRECTOR 15  
    octinoxate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-110
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7.5 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide4.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Glycerin (UNII: PDC6A3C0OX)  
    ALLANTOIN (UNII: 344S277G0Z)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    STEARETH-2 (UNII: V56DFE46J5)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66078-110-2542 in 1 CASE
    11 in 1 CARTON
    178 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/08/2007
    Labeler - MD Formulation (087008363)
    Registrant - Ei Inc (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei Inc105803274manufacture(66078-110) , pack(66078-110) , label(66078-110)
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