Label: OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE- octinoxate,octisalate,avobenzone,octocrylene,ensulizole,titanium dioxide cream

  • 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 March 4, 2019

If you are a consumer or patient please visit this version.

  • LOSANIKA COFFEE BB CREAM BROAD SPECTRUM SPF 30 - Avobenzone 2%,Octocrylene 2%,Octinoxate 6%,Ensulizole 2%,Octisalate 4.5%. Titanium Dioxide 2.4% CREAM

    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.

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  • PURPOSE:

    Sunscreen

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  • DRUG FACTS:
  • Active Ingredients:

    AVOBENZONE 2%

    OCTOCRYLENE 2%

    OCTINOXATE 6%

    ENSULIZOLE 2%

    OCTISALATE 4.5%

    TITANIUM DIOXIDE 2.4%

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  • USES:

    For all sunscreen drug products:
    “helps prevent sunburn

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  • WARNING:


    For external use only

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  • When using this product:

    keep out of eyes. Rinse with water to remove.

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  • Stop use and ask a Doctor:

    if rash or irritation develops or lasts.

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  • Keep out of reach of children:

    If the product is swallowed get medical help or contact a poison control center right away.

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  • Directions:

    Apply generously and evenly 15 minutes before sun exposure

    Reapply at least every two hours
    Use water resistant sun protector if swimming or sweating.
    Sun protection measures:
    Overexposure to the sun is dangerous. Increases the risk of causing skin cancer and premature aging.
    To reduce the risk, regularly use sunscreen with broad spectrum SPF 15 or higher, combined with other sun protection measures.
    Limit exposure time especially between 10 am - 2 pm.
    Wear long sleeves, hat and glasses.
    Children under 6 months of age ask a doctor.

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  • Inactive Ingredients:

    Water/Aqua, Aloe Barbadensis Leaf Water, Coffea Arabica Seed Extract, Coffea Arabica Seed Oil, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate, C12-15 Alkyl Benzoate, Aluminum Starch Octenylsuccinate, Butyl Methoxydibenzoylmethane, Phenylbenzimidazole Sulfonic Acid, Octocrylene, Propylheptyl Caprylate,Titanium Dioxide, Calendula officinalis flower extract, Cetearyl Alcohol, Dicaprylyl Carbonate(and)Stearalkonium Hectorite (and) Propylene Carbonate, Polyglyceryl-2 Dipolyhydroxystearate, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Panthenol,Sodium Polyacrylate, Phenoxyethanol and Caprylyl Glycol, Xanthan Gum, Polyamide – 3, Cymbopongo citratus leaf oil , Lippia Alba Leaf/Stem Oil, Citrus nobilis (mandarin orange) peel oil, CI 77891 (Titanium dioxide), CI 77491 (Iron oxide red), CI 77492 (Iron oxide yellow), CI 77499 (Iron oxide Black).

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  • Ohter Information:

    Protect from excessive heat and direct sunlight.

    Formulated with out:

    Parabens, silicones, mineral oils, paraffins and synthetic fragrances

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  • CONTENT OF LABELING
  • INGREDIENTS AND APPEARANCE
    OCTINOXATE,OCTISALATE,AVOBENZONE,OCTOCRYLENE,ENSULIZOLE,TITANIUM DIOXIDE 
    octinoxate,octisalate,avobenzone,octocrylene,ensulizole,titanium dioxide cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:71801-541
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 4.5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2 g  in 100 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE 2 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 6 g  in 100 g
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.4 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYAMIDE-3 (12000 MW) (UNII: L7P3YWF22X)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    LIPPIA ALBA WHOLE (UNII: 76HT054LK1)  
    MANDARIN OIL (UNII: NJO720F72R)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    SODIUM ACRYLATE (UNII: 7C98FKB43H)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    WATER (UNII: 059QF0KO0R)  
    ARABICA COFFEE BEAN (UNII: 3SW678MX72)  
    ARABICA COFFEE OIL (UNII: IK55HKE887)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:71801-541-01 30 g in 1 BOX; Type 0: Not a Combination Product 09/01/2017
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part352 09/01/2017
    Labeler - PROKPIL SAS (886026583)
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