Label: CY BB FACIAL HIDRATANTE CON COLOR FPS 25 MULTIBENEFICIOS- octinoxate and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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 29, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    ZINC OXIDE 8.4%Sunscreen
    OCTINOXATE 7%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 damaged 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.
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: Ask a doctor
  • Other information

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

    WATER, DIMETHICONE, PEG-10 DIMETHICONE, GLYCERIN, PEG/PPG-18/18 DIMETHICONE, POLYMETHYLSILSESQUIOXANE, POLYSILICONE-11, SILICA, HYDROXYACETOPHENONE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, PHENOXYETHANOL, BUTYLENE GLYCOL, SODIUM CHLORIDE, METHYLPROPANEDIOL, CAPRYLYL GLYCOL, DISTEARDIMONIUM HECTORITE, CHLORPHENESIN, SILANEDIOL SALICYLATE, TROMETHAMINE, TRIETHOXYCAPRYLYLSILANE, THEOBROMA CACAO (COCOA) SEED EXTRACT. MAY CONTAIN: TITANIUM DIOXIDE, IRON OXIDES.

  • SPL UNCLASSIFIED SECTION

    Dist. by Ventura Corp.
    Ltd., San Juan, Puerto Rico 00926.

  • PRINCIPAL DISPLAY PANEL - 25 g Tube Box

    cy°

    BB CREAM

    cy°zone

    Net wt. 0.88 oz. e (25 g)

    PRINCIPAL DISPLAY PANEL - 25 g Tube Box
  • INGREDIENTS AND APPEARANCE
    CY BB FACIAL HIDRATANTE CON COLOR FPS 25 MULTIBENEFICIOS 
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0078
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE0.084 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    4-HYDROXY ACETOPHENONE (UNII: G1L3HT4CMH)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHYLPROPANEDIOL (UNII: N8F53B3R4R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SILANEDIOL SALICYLATE (UNII: C054DF30K0)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    COCOA (UNII: D9108TZ9KG)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43596-0078-21 in 1 BOX12/01/2017
    1NDC:43596-0078-125 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35212/01/2017
    Labeler - Ventura Corporation LTD (602751344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Bel Star S.A. (Colombia)880160197MANUFACTURE(43596-0078)
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