BANILA CO PRIME PRIMER SUN- avobenzone, octinoxate, octocrylene, octisalate, homosalate, ensulizole cream 
F&CO Co., Ltd.

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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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 cartonImage of carton

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 CARTON10/01/201711/01/2019
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 finalpart35210/01/201711/01/2019
Labeler - F&CO Co., Ltd. (690166186)
Registrant - F&CO Co., Ltd. (690166186)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(69106-430)

Revised: 1/2020
 
F&CO Co., Ltd.