BANILA CO Prime Primer Sun by F&CO Co., Ltd. / Cosmax, Inc

BANILA CO Prime Primer Sun by

Drug Labeling and Warnings

BANILA CO Prime Primer Sun by is a Otc medication manufactured, distributed, or labeled by F&CO Co., Ltd., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-430
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	Avobenzone	1.05 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.07 g  in 30 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	Octocrylene	0.60 g  in 30 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	1.35 g  in 30 mL
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	0.90 g  in 30 mL
Ensulizole (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	Ensulizole	1.05 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-430-02	1 in 1 CARTON	10/01/2017	11/01/2019
1	NDC: 69106-430-01	30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2017	11/01/2019

Labeler - F&CO Co., Ltd. (690166186)

Registrant - F&CO Co., Ltd. (690166186)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(69106-430)

Revised: 1/2020

Document Id: eb2ec704-58a6-4e1f-8b12-f34063323293

34390-5

Set id: 29a56f83-e179-4d25-927e-63d50ae542c7

Version: 2

Effective Time: 20200103

 

F&CO Co., Ltd.