Label: CYZONE- octinoxate and octocrylene ointment

  • 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 November 10, 2010

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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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