Label: SUN TOTAL PROTECTOR 30 BROAD SPECTRUM SPF 30 DAILY PROTECTION- octinoxate, octisalate, 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 January 28, 2013

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  • Acive ingredients:

    Octinoxate 7.5%

    Octisalate 4.0%

    Zinc Oxide 7.8%

  • Warning:

    For external use only. Keep out of reach of children. If swallowed get medical help or contact a poison control center right away.

    Not for resale.

  • Directions:

    Apply to skin prior to sun exposure and reapply as needed.

  • Labeling

    Label

  • INGREDIENTS AND APPEARANCE
    SUN TOTAL PROTECTOR 30 BROAD SPECTRUM SPF 30 DAILY PROTECTION 
    octinoxate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66078-440
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.0 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE7.8 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)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    STEARETH-2 (UNII: V56DFE46J5)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    STEARETH-100 (UNII: 4OH5W9UM87)  
    TRICONTANYL POVIDONE (4 TRICONTANYL BRANCHES/REPEAT) (UNII: N0SS3Q238D)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66078-440-0310.8 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/15/2012
    Labeler - MD Formulation. (087008363)
    Registrant - Ei Inc. (105803274)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ei Inc.105803274manufacture(66078-440) , label(66078-440)
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