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

BANILA CO Prime Primer Fitting BB Natural Beige by

Drug Labeling and Warnings

BANILA CO Prime Primer Fitting BB Natural 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 NATURAL 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, Iron Oxides (CI 77492), Phenoxyethanol, Sorbitan Sesquioleate, Aluminum Hydroxide, Glyceryl Behenate, Polyglyceryl-6 Octastearate, Iron Oxides (CI 77491), Stearic Acid, Fragrance(Parfum), Triethoxycaprylylsilane, Iron Oxides (CI 77499), Ethylhexylglycerin, 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

BANILA CO PRIME PRIMER FITTING BB NATURAL BEIGE 
titanium dioxide, zinc oxide, octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69106-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.90 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.88 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.50 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69106-420-02	1 in 1 CARTON	10/01/2017	11/01/2019
1	NDC: 69106-420-01	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(69106-420)

Revised: 1/2020

Document Id: 18d17600-2cf8-448c-95cc-ae54d17975f9

34390-5

Set id: b1c7e68f-b99d-4dc0-9fe0-74efd02608a2

Version: 2

Effective Time: 20200103