Label: DUKE CANNON STANDARD ISSUE FACE- sunscreen 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 September 21, 2021

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  • ACTIVE INGREDIENT

    active ingredients

  • PURPOSE

    purpose

  • INACTIVE INGREDIENT

    inactive ingredients

  • PRINCIPAL DISPLAY PANEL

    package label principal

  • INGREDIENTS AND APPEARANCE
    DUKE CANNON STANDARD ISSUE FACE 
    sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60717-906
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE0.05 g  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.03 g  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE0.065 g  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE0.02 g  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.075 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    RICE BRAN (UNII: R60QEP13IC)  
    ROSEMARY (UNII: IJ67X351P9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    GLYCERYL 1-STEARATE (UNII: 258491E1RZ)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60717-906-1750 mL in 1 TUBE; Type 0: Not a Combination Product09/21/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35209/21/2021
    Labeler - RNA PHARMA, LLC (079103999)
    Establishment
    NameAddressID/FEIBusiness Operations
    RNA PHARMA, LLC079103999manufacture(60717-906)