CYZONE (OCTINOXATE, OXYBENZONE, AND ZINC OXIDE) LIPSTICK [VENTURA CORPORATION LTD.]

CYZONE (OCTINOXATE, OXYBENZONE, AND ZINC OXIDE) LIPSTICK [VENTURA CORPORATION LTD.]
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NDC 13537-300-01, 13537-300-02
Set ID 9fea0a88-ab56-4b2e-b695-b24cd48fb1a8
Category HUMAN OTC DRUG LABEL
Packager Ventura Corporation Ltd.
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Octinoxate 7%, Oxybenzone 2%, Zinc Oxide 1%.

  • Purpose

    Sunscreen.

  • Uses

    Helps prevent sunburn.

  • Warnings

  • STOP USE

    Stop use if skin rash occurs.

  • Inactive ingredients

    Caprylic/capric triglyceride, diisopropyl dimer dilinoleate, ricinus communis seed oil (ricinus communis (castor) seed oil), octyldodecanol, hydrogenated polyisobutene, polyethylene, candelilla cera (euphorbia cerifera (candelilla) wax), cera alba (beeswax), copernicia cerifera cera (copernicia cerifera (carnauba) wax), CI 77019 (mica), parfum (fragrance), dipalmitoyl hydroxyproline, glyceryl isostearate, isostearyl alcohol, glycerin, butyrospermum parkii (butyrospermum parkii (shea butter), bertholletia excelsa seed oil, orbignya oleifera seed oil, tocopheryl acetate, beta-sitosterol, sodium saccharin, silica dimethyl silylate, cetearyl ethylhexanoate, propylparaben, cera microcristallina (microcrystalline wax), bht, butyl methoxydibenzoylmethane, petrolatum, cetyl alcohol, phospholipids, hydrogenated coconut oil, ethylhexyl salicylate, cholesterol, oleyl alcohol, triethoxycaprylylsilane, ozokerite, dimethicone, polyglyceryl-2 dipolyhydroxystearate, cetearyl glucoside, cetearyl alcohol, cetyl ricinoleate, glycosphingolipids, trimethylsiloxysilicate. May Contain: Calcium aluminum borosilicate, CI 77891 (titanium dioxide), CI 45380 (red 21 lake), CI 15850 (red 7 lake), CI 45410 (red 27 lake), CI 16035 (red 40 lake), CI 77491 (iron oxides), CI 77492 (iron oxides), silica, CI 19140 (yellow 5 lake), talc, CI 77499 (iron oxides), tin oxide, CI 75470 (carmine), palmitic acid, methylparaben, butylparaben.

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 4,5 g Label

    better lips balm

    Humectante para labios
    con color FPS 18 UVA UVB

    cy°

    cy°zone
    4,5 g e (.15 oz.)

    PRINCIPAL DISPLAY PANEL - 4,5 g Label
  • INGREDIENTS AND APPEARANCE
    CYZONE   BETTER LIPS BALM
    octinoxate, oxybenzone, and zinc oxide lipstick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-300
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate70 mg  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone20 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    MICA (UNII: V8A1AW0880)  
    DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    BRAZIL NUT OIL (UNII: 0G89T29HO6)  
    BABASSU OIL (UNII: 8QSB4M5477)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    CETEARYL ETHYLHEXANOATE (UNII: 9M64UO4C25)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    AVOBENZONE (UNII: G63QQF2NOX)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    HYDROGENATED COCONUT OIL (UNII: JY81OXM1OM)  
    OCTISALATE (UNII: 4X49Y0596W)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    OLEYL ALCOHOL (UNII: 172F2WN8DV)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    D&C RED NO. 21 (UNII: 08744Z6JNY)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    D&C RED NO. 27 (UNII: 2LRS185U6K)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    TALC (UNII: 7SEV7J4R1U)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-300-011 in 1 BOX
    1NDC:13537-300-024.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/28/2011
    Labeler - Ventura Corporation Ltd. (602751344)

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