PROVENCE AIR SKIN FIT BB CREA M 02 NATURAL BEIGE- titanium dioxide, octinoxate, octisalate cream

PROVENCE AIR SKIN FIT BB CREA M 02 NATURAL BEIGE by

Drug Labeling and Warnings

PROVENCE AIR SKIN FIT BB CREA M 02 NATURAL BEIGE by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients: Titanium Dioxide 7.16%, Ethylhexyl Methoxycinnamate 7.00%, Ethylhexyl Salicylate 3.00%

INACTIVE INGREDIENT

Inactive ingredients: Water, Cyclopentasiloxane, Glycerin, Cyclohexasiloxane, Butylene Glycol, Butylene Glycol Dicaprylate/Dicaprate, Dicaprylyl Carbonate, Diphenylsiloxy Phenyl Trimethicone, Niacinamide, Pentylene Glycol, Methyl Methacrylate Crosspolymer, Iron Oxides (CI 77492), Phenoxyethanol, Triceteareth-4 Phosphate, Glycol Stearate, PEG-10 Dimethicone, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Cetearyl Alcohol, Cetyl Dimethicone, Glyceryl Stearate, PEG-100 Stearate, Polysorbate 60, Potassium Cetyl Phosphate, PEG-2 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aluminum Hydroxide, Sodium Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Triethoxycaprylylsilane, Iron Oxides (CI 77491), Tromethamine, Isohexadecane, Ethylhexylglycerin, Fragrance(Parfum), Iron Oxides (CI 77499), Adenosine, Polysorbate 80, Disodium EDTA, Sorbitan Oleate, Aloe Barbadensis Leaf Extract, Chamomilla Recutita (Matricaria) Flower Water, Rosa Centifolia Flower Water, Mica (CI 77019), Camellia Sinensis Leaf Extract, Alcohol, Saccharomyces Ferment

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: For external use only Avoid contact with eyes. Discontinue use if signs of irritation or rashes appear. Replace the cap after use. Keep Out of Reach of Children

DESCRIPTION

Uses: The BB cream with an air-like texture perfectly adheres to the skin

Directions: Apply an appropriate amount to the entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE AIR SKIN FIT BB CREA M 02 NATURAL BEIGE  
titanium dioxide, octinoxate, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-483
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	2.14 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	2.10 g  in 30 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.90 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-483-02	1 in 1 CARTON	06/01/2017
1	NDC: 51346-483-01	30 mL in 1 BOTTLE, PUMP; 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	06/01/2017

Labeler - NATURE REPUBLIC CO., LTD. (631172020)

Registrant - NATURE REPUBLIC CO., LTD. (631172020)

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	relabel(51346-483)

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc		689049693	manufacture(51346-483)