Label: OCTISALATE,OCTOCRYLENE,OCTINOXATE,ZINC OXIDE,TITANIUM DIOXIDE,ENSULIZOLE 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 June 18, 2018

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

  • LOSANIKA ALOE & CALENDULA ANTIOXIDANT SUNSCREEN BROAD SPECTRUM SPF 30 - ENSULIZOLE 2.0 %, TITANIUM DIOXIDE 2.4 %, OCTOCRYLENE 3.0 %, ZINC OXIDE 3.5 %, OCTISALATE 4.5 %, OCTINOXATE 6.5 %

    Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they maybe marketed if they comply with

    regulations and policies. FDA has not evaluated weather this product complies.

  • PURPOSE:

    SUNSCREEN

  • DRUG FACTS:

  • ACTIVE INGREDIENTS:

    ENSULIZOLE 2.0 %

    TITANIUM DIOXIDE 2.4 %

    OCTOCRYLENE 3.0 %

    ZINC OXIDE 3.5 %

    OCTISALATE 4.5 %

    OCTINOXATE 6.5 %

  • USES:

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (seek Directions), decreases

    the risk of skin cancer and early skin aging caused by the sun.

  • WARNING:

    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 or irritation develops or lasts.

  • KEEP OUT OF REACH OF CHILDREN:

    If swallowed, get medical help or contact a Poison Control Center right away

  • DIRECTIONS:

    Apply liberally 15 minutes before sun exposure

    Use water resistant sun protector if swimming or sweating.
    Reapply at least every two hours.
    Children under six months: ask a doctor

    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.

  • INACTIVE INGREDIENTS:

    Water (Aqua), Aloe vera (Aloe) Leaf juice, Calendula officinalis (calendula) flower extract, Aluminum Starch Octenylsuccinate,C12-15 Alkyl Benzoate, Propylheptyl Caprylate, Dicaprylyl Carbonate (and) Stearalkonium Hectorite (and) Propylene Carbonate, Cetearyl Alcohol, Hydrogenated Castor Oil, Polyglyceryl-2 Dipolyhydroxystearate, Coffea arabica (Coffee) seed oil, Sodium Stearoyl Glutamate, Tocopheryl Acetate(E), Niacinamide (B3), Panthenol, Glycerin, Xanthan Gum, Fragrance, Phenoxyethanol (And) Decylene Glycol (And) Caprylyl Glycol, Bixa Orellana Seed Extract (Annato), Cymbopogon citratus (lemongrass) oil, Zingiber officinale (ginger) root oil, Citrus sinensis (sweet orange) peel oil, Lippia alba (bushy matgrass) leaf/stem oil.

  • OTHER INFORMATION:

    Protect from excessive heat and direct sunlight.

    Formulated without: parabens, silicones, mineral oils, synthetic dyes.

  • CONTENT OF LABELING:

    CONTENT OF LABELING

  • INGREDIENTS AND APPEARANCE
    OCTISALATE,OCTOCRYLENE,OCTINOXATE,ZINC OXIDE,TITANIUM DIOXIDE,ENSULIZOLE 
    octisalate,octocrylene,octinoxate,zinc oxide,titanium dioxide,ensulizole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71801-542
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.4 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 100 g
    ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) ENSULIZOLE2 g  in 100 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6.5 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    PROPYLHEPTYL CAPRYLATE (UNII: 991Z19V2OD)  
    HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BIXA ORELLANA SEED (UNII: O87354RZ5A)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DECYLENE GLYCOL (UNII: S57M60MI88)  
    GINGER OIL (UNII: SAS9Z1SVUK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    WATER (UNII: 059QF0KO0R)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    ARABICA COFFEE OIL (UNII: IK55HKE887)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LIPPIA ALBA WHOLE (UNII: 76HT054LK1)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71801-542-0130 g in 1 BOX; Type 0: Not a Combination Product06/18/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/18/2018
    Labeler - PROKPIL SAS (886026583)