BANILA CO Prime Primer Fitting BB Light Beige by F&CO Co., Ltd. / Cosmax, Inc

BANILA CO Prime Primer Fitting BB Light Beige by

Drug Labeling and Warnings

BANILA CO Prime Primer Fitting BB Light Beige 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 FITTING BB LIGHT BEIGE- titanium dioxide, zinc oxide, octinoxate 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: Titanium Dioxide 9.69%, Zinc Oxide 2.94%, Ethylhexyl Methoxycinnamate 5.0%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: Cyclopentasiloxane, Water, C30-45 Alkyl Cetearyl Dimethicone Crosspolymer, Dimethicone, PEG-10 Dimethicone, Pentylene Glycol, Triethylhexanoin, Methyl Methacrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Sodium Chloride, Phenoxyethanol, Iron Oxides (CI 77492), Sorbitan Sesquioleate, Aluminum Hydroxide, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Stearic Acid, Fragrance(Parfum), Iron Oxides (CI 77491), Triethoxycaprylylsilane, Ethylhexylglycerin, Iron Oxides (CI 77499), Disodium EDTA, Silica, Butylene Glycol, Fomes Officinalis (Mushroom) Extract, Glycerin, Phenyl Trimethicone, Carrageenan, Portulaca Oleracea Extract, PEG-40 Hydrogenated Castor Oil, Hydrogenated Lecithin, Propylene Glycol, Algin, Chlorphenesin, Potassium Sorbate, Sodium Benzoate, Sodium Dehydroacetate, Citric Acid, Sorbic Acid, Polysorbate 60

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

BANILA CO PRIME PRIMER FITTING BB LIGHT BEIGE 
titanium dioxide, zinc oxide, octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69106-410
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide2.90 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION0.88 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate1.50 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Dimethicone (UNII: 92RU3N3Y1O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69106-410-021 in 1 CARTON10/01/201711/01/2019
1NDC: 69106-410-0130 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(69106-410)

Revised: 1/2020
Document Id: a4f06b4e-644b-4068-9936-9d4c4347f924
Set id: c9704b72-f598-4524-a243-a10f382b1ae7
Version: 2
Effective Time: 20200103
 
F&CO Co., Ltd.