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LBEL (Ventura International Ltd. (San Juan, P.R))

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LOTION 12 mL in 1 BOTTLE, PLASTIC (14783-121-01) Label Information

Complete LBEL Information

  • Active Ingredients

    Octinoxate 7.5%, Oxybenzone 3.0%.


  • Purpose

    Sunscreen.


  • Uses

    Helps prevent sunburn.


  • Warnings

    Stop use if skin rash occurs.


  • Inactive Ingredients

    Hydrogenated polyisobutene, diisopropyl dimer dilinoleate, isostearyl neopentanoate, cera alba (beeswax), silica dimethyl silylate, parfum (fragrance), parfum (fragrance), glycerin, prunus amygdalus dulcis oil (prunus amygdalus dulcis (sweet almond) oil), tocopheryl acetate, cocos nucifera oil (cocos nucifera (coconut) oil), aloe barbadensis leaf extract, hydrogenated vegetable oil, propylparaben, methylparaben, sodium saccharin, bht, citrus limon peel cera (citrus limon (lemon) peel wax), citrus limon peel oil (citrus limon (lemon) peel oil), citrus aurantium dulcis peel oil (citrus aurantium dulcis (orange) peel oil), citrus aurantium dulcis peel cera (citrus aurantium dulcis (orange) peel wax). May Contain: CI 77019 (mica), CI 15850 (red 7 lake), CI 77891 (titanium dioxide ), CI 77491, CI 77492, CI 77499 (iron oxides), CI 19140 (yellow 5 lake), CI 16035 (red 40 lake), CI 42090 (blue 1 lake), CI 75470 (carmine), talc, palmitic acid.


  • SPL UNCLASSIFIED SECTION

    USA: Dist. by Ventura International Ltd. San Francisco, CA 94111.


  • PRINCIPAL DISPLAY PANEL - 12 ml Bottle Carton

    DIVINE LIP GLOSS

    Lip gloss SPF 15

    12 ml e (.40 fl.oz.)

    L'BEL

    Principal Display Panel - 12 ml Bottle Carton

  • INGREDIENTS AND APPEARANCE
    LBEL   DIVINE LIP GLOSS SPF 15
    octinoxate and oxybenzone lotion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14783-121
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate 0.075 mL  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 0.03 mL  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    diisopropyl dilinoleate (UNII: 5323S7S2LR)  
    isostearyl neopentanoate (UNII: 411THY156Q)  
    yellow wax (UNII: 2ZA36H0S2V)  
    silica dimethyl silylate (UNII: EU2PSP0G0W)  
    glycerin (UNII: PDC6A3C0OX)  
    almond oil (UNII: 66YXD4DKO9)  
    alpha-tocopherol acetate (UNII: 9E8X80D2L0)  
    coconut oil (UNII: Q9L0O73W7L)  
    aloe vera leaf (UNII: ZY81Z83H0X)  
    propylparaben (UNII: Z8IX2SC1OH)  
    methylparaben (UNII: A2I8C7HI9T)  
    saccharin sodium (UNII: SB8ZUX40TY)  
    butylated hydroxytoluene (UNII: 1P9D0Z171K)  
    lemon peel wax (UNII: 20G0UPO0TI)  
    lemon oil (UNII: I9GRO824LL)  
    orange oil (UNII: AKN3KSD11B)  
    orange peel wax (UNII: 0U715N387C)  
    mica (UNII: V8A1AW0880)  
    D&C red no. 7 (UNII: ECW0LZ41X8)  
    titanium dioxide (UNII: 15FIX9V2JP)  
    ferric oxide red (UNII: 1K09F3G675)  
    ferric oxide yellow (UNII: EX438O2MRT)  
    ferrosoferric oxide (UNII: XM0M87F357)  
    FD&C yellow no. 5 (UNII: I753WB2F1M)  
    FD&C red no. 40 (UNII: WZB9127XOA)  
    FD&C blue no. 1 (UNII: H3R47K3TBD)  
    aluminum oxide (UNII: LMI26O6933)  
    cochineal (UNII: TZ8Z31B35M)  
    talc (UNII: 7SEV7J4R1U)  
    palmitic acid (UNII: 2V16EO95H1)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14783-121-01 12 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part352 11/14/2011
    Labeler - Ventura International Ltd. (San Juan, P.R) (603192787)
    Establishment
    Name Address ID/FEI Business Operations
    Bel Star, S. A.(Colombia) 880160197 MANUFACTURE(14783-121)
    Establishment
    Name Address ID/FEI Business Operations
    Yobel Supply Chain Management (Peru) 934116930 MANUFACTURE(14783-121)