Label: CYZONE CY PERLIPS LABIAL HIDRATANTE CON PERLAS DE LUZ Y FPS 20- octinoxate and oxybenzone cream

  • 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 July 14, 2012

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    OCTINOXATE 7.0 % , OXYBENZONE 2.5 %

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • Warnings

    • Skin Cancer / Skin Aging Alert; Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
    • For external use only.

    • Do not use on damage or broken skin.

    • When using this product keep out of eyes. Rinse with water to remove.

    • Stop use and ask a doctor if rash occurs.

    • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally and evenly 15 minutes before sun exposure.
    • Children under 6 months of age: Ask a doctor.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
  • Other information

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive ingredients

    RICINUS COMMUNIS SEED OIL (RICINUS COMMUNIS (CASTOR) SEED OIL), CAPRYLIC/CAPRIC TRIGLYCERIDE, POLYETHYLENE, CERA ALBA (BEESWAX), CANDELILLA CERA (EUPHORBIA CERIFERA (CANDELILLA) WAX), HYDROGENATED VEGETABLE OIL, BUTYROSPERMUM PARKII BUTTER (BUTYROSPERMUM PARKII (SHEA) BUTTER), SILICA DIMETHYL SILYLATE, GLYCERIN, OCTYLDODECANOL, PARFUM (FRAGRANCE), GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, HELIANTHUS ANNUUS SEED OIL (HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL), SODIUM SACCHARIN, PROPYLPARABEN, MICROCRISTALLINA CERA (MICROCRYSTALLINE WAX), BETA-SITOSTEROL, PETROLATUM, BHT, TOCOPHERYL ACETATE, PHOSPHOLIPIDS, CHOLESTEROL, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA CERA (COPERNICIA CERIFERA (CARNAUBA ) WAX), POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS. May contain:: CI 77742 (MANGANESE VIOLET), CI 15850 (RED 7 LAKE), CI 77492 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), SYNTHETIC FLUORPHLOGOPITE, CI 19140 (YELLOW 5 LAKE), CI 73360 (RED 30).

  • SPL UNCLASSIFIED SECTION

    Distributed by Ventura Corporation, Ltd., San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 4 g Stick Label

    perlips
    labial hidratante con
    perlas de luz y FPS 20

    cy°

    cy°zone
    4 g e (.14 oz.)

    Principal Display Panel - 4 g Stick Label
  • INGREDIENTS AND APPEARANCE
    CYZONE   CY PERLIPS LABIAL HIDRATANTE CON PERLAS DE LUZ Y FPS 20
    octinoxate and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-432
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.07 g  in 1 g
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone0.025 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CASTOR OIL (UNII: D5340Y2I9G)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
    ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)  
    .BETA.-SITOSTEROL (UNII: S347WMO6M4)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    MANGANESE VIOLET (UNII: 72M48QQV8Q)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 30 (UNII: 2S42T2808B)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:13537-432-014 g in 1 TUBE, WITH APPLICATOR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35207/13/2012
    Labeler - Ventura Corporation LTD. (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-432)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yobel Supply Chain Management S.A. (Peru)934116930MANUFACTURE(13537-432)
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