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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP), Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37), Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

Available from:

F&CO Co., Ltd.

INN (International Name):

Titanium Dioxide

Composition:

Titanium Dioxide 2.90 g in 30 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

PURPOSE: Sunscreen

Authorization status:

OTC monograph not final

Summary of Product characteristics

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 T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 9 10 6 -420
ROUTE OF ADMINISTRATION
TOPICAL
F&CO Co., Ltd.
ACTIVE ING