CYZONE (OCTINOXATE AND OCTOCRYLENE) OINTMENT [VENTURA CORPORATION LIMITED]

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CYZONE (OCTINOXATE AND OCTOCRYLENE) OINTMENT [VENTURA CORPORATION LIMITED]
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NDC 13537-012-14, 13537-012-15, 13537-013-14, 13537-013-15, 13537-014-14, 13537-014-15, 13537-015-14, 13537-015-15
Set ID 1f7711ff-ca6c-4891-8eb3-808c8c7d1338
Category HUMAN OTC DRUG LABEL
Packager Ventura Corporation Limited
Generic Name
Product Class
Product Number
Application Number PART352
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  • Active Ingredients

    Octinoxate: 6.0%, Octocrylene: 4,0%.

  • Purpose

    Sunscreen.

  • Uses

    Helps prevent sunburn.

  • Warnings

    Stop use if skin rash occurs.

  • Ingredients

    Diisopropyl dimer dilinoleate, petrolatum, polybutene, butyrospermum parkii (butyrospermum parkii (shea butter)), cera alba (beeswax), silica, cera microcristallina (microcrystalline wax), parfum (fragrance), silica dimethyl silylate, bht, caprylic/capric triglyceride, diethylhexyl syringylidene malonate, glycerin, methylparaben, ozokerite, propylparaben, sodium saccharin, theobroma cacao seed butter (theobroma cacao (cocoa) seed butter), tocopheryl acetate. May contain: CI 77019 (mica), CI 45380 (red 21 lake), CI 77891 (titanium dioxide), CI 15850 (red 7 lake), CI 19140 (yellow 5 lake), CI 42090 (blue 1 lake), CI 45410 (red 27 lake).

  • SPL UNCLASSIFIED SECTION

    P.R.:Dist. by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

  • PRINCIPAL DISPLAY PANEL - 14 g CherryLemon Container

    humectante para labios con aroma FPS 15
    14 g e (.49 oz.)

    cy°bulkyz

    Principal Display Panel - 14 g CherryLemon Container
  • PRINCIPAL DISPLAY PANEL - 14 g PassionBerry Container

    humectante para labios con aroma FPS 15
    14 g e (.49 oz.)

    cy°bulkyz

    Principal Display Panel - 14 g PassionBerry Container
  • PRINCIPAL DISPLAY PANEL - 14 g MintGrape Container

    humectante para labios con aroma FPS 15
    14 g e (.49 oz.)

    cy°bulkyz

    Principal Display Panel - 14 g MintGrape Container
  • PRINCIPAL DISPLAY PANEL - 14 g CocoPine Container

    humectante para labios con aroma FPS 15
    14 g e (.49 oz.)

    cy°bulkyz

    Principal Display Panel - 14 g CocoPine Container
  • INGREDIENTS AND APPEARANCE
    CYZONE   CY
    octinoxate and octocrylene ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CHOCOLATE (UNII: D9108TZ9KG)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCHERRY, LEMONImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-012-151 in 1 CARTON
    1NDC:13537-012-1414 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/21/2011
    CYZONE   CY
    octinoxate and octocrylene ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CHOCOLATE (UNII: D9108TZ9KG)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBERRY (PassionBerry) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-013-151 in 1 CARTON
    1NDC:13537-013-1414 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/21/2011
    CYZONE   CY
    octinoxate and octocrylene ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-014
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CHOCOLATE (UNII: D9108TZ9KG)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT, GRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-014-151 in 1 CARTON
    1NDC:13537-014-1414 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/21/2011
    CYZONE   CY
    octinoxate and octocrylene ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.06 g  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.04 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CHOCOLATE (UNII: D9108TZ9KG)  
    MICA (UNII: V8A1AW0880)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorCOCONUT (CocoPine) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-015-151 in 1 CARTON
    1NDC:13537-015-1414 g in 1 CONTAINER
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35201/21/2011
    Labeler - Ventura Corporation Limited (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    BelStar, S.A.880160197MANUFACTURE
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