Label: BANILA CO PRIME PRIMER SUN- avobenzone, octinoxate, octocrylene, octisalate, homosalate, ensulizole cream

  • NDC Code(s): 69106-430-01, 69106-430-02
  • Packager: F&CO Co., Ltd.
  • 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 November 8, 2017

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

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS: Butyl Methoxydibenzoylmethane 3.5%, Ethylhexyl Methoxycinnamate 6.9%, Octocrylene 2.0%, Ethylhexyl Salicylate 4.5%, Homosalate 3.0%, Phenylbenzimidazole Sulfonic Acid3.5%

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Water, Butylene Glycol, Ethylhexyl Palmitate, Niacinamide, Pentaerythrityl Distearate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Caprylic/Capric Triglyceride, Aminomethyl Propanol, Sodium Polyacrylate, C12-15 Alkyl Benzoate, Ethylhexyl Stearate, Glyceryl Stearate, Methyl Methacrylate Crosspolymer, PEG-100 Stearate, Sodium Stearoyl Glutamate, Polysorbate 60, Dipropylene Glycol Dibenzoate, Phenoxyethanol, Caprylyl Glycol, Fragrance(Parfum), Glyceryl Caprylate, PPG-15 Stearyl Ether Benzoate, Trideceth-6, Adenosine, Xanthan Gum, Disodium EDTA, Jasminum Officinale (Jasmine) Flower/Leaf Extract, Nelumbo Nucifera Flower Extract, Freesia Refracta Extract, Iris Versicolor Extract, Leontopodium Alpinum Flower/Leaf Extract, Lilium Candidum Bulb Extract, Narcissus Pseudo-Narcissus (Daffodil) Flower Extract, Rose Extract

  • PURPOSE

    PURPOSE: Sunscreen

  • WARNINGS

    WARNINGS: If redness or irritation occurs, discontinue use, and consult a dermatologist. Do not use on broken skin. For external use only. Replace the cap after use. Keep out of reach of children. Do not expose to heat or direct sunlight. Do not store at high temperatures. Avoid contact with eyes.

  • INDICATION AND USAGE

    INDICATION AND USAGE: Evenly spread moderate amount on skin on final skin care.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    BANILA CO PRIME PRIMER SUN 
    avobenzone, octinoxate, octocrylene, octisalate, homosalate, ensulizole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69106-430
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone1.05 g  in 30 mL
    Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate2.07 g  in 30 mL
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene0.60 g  in 30 mL
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.35 g  in 30 mL
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate0.90 g  in 30 mL
    Ensulizole (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42) Ensulizole1.05 g  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69106-430-021 in 1 CARTON10/01/2017
    1NDC:69106-430-0130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2017
    Labeler - F&CO Co., Ltd. (690166186)
    Registrant - F&CO Co., Ltd. (690166186)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmax, Inc689049693manufacture(69106-430)