PROVENCE FOUNDATION SPF31 PA PLUS PLUS NO 21- titanium dioxide, octinoxate, zinc oxide cream

PROVENCE FOUNDATION by

Drug Labeling and Warnings

PROVENCE FOUNDATION by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients: Titanium Dioxide 10.43%, Ethylhexyl Methoxycinnamate 4%, Zinc Oxide 0.98%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Cyclopentasiloxane, Trimethylsiloxysilicate, Diphenylsiloxy Phenyl Trimethicone, Butylene Glycol, PEG-10 Dimethicone, Cyclohexasiloxane, Glycerin, Niacinamide, Butylene Glycol Dicaprylate/Dicaprate, Tribehenin, Sodium Chloride, Iron Oxides (CI 77492),
Methyl Methacrylate Crosspolymer, Neopentyl Glycol Diheptanoate, Disteardimonium Hectorite, Phenoxyethanol, Sorbitan Isostearate, Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Iron Oxides (CI 77491), Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Triethoxycaprylylsilane, Dimethiconol, Iron Oxides (CI 77499), Aluminum Hydroxide, Fragrance(Parfum), Stearic Acid, Dimethicone Crosspolymer, Ethylhexylglycerin, Disodium EDTA, Adenosine, Copernicia Cerifera (Carnauba) Wax, Rosmarinus Officinalis (Rosemary) Leaf Extract,
Rosa Canina Fruit Oil, Glyceryl Behenate/Eicosadioate

PURPOSE

PURPOSE: Sunscreen

WARNINGS

Cautions:
For external use only.
Avoid contact with eyes and mouth.
Discontinue use if signs of irritation or rashes appear.
Keep out of reach of children.
Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

INDICATIONS AND USAGE

How to Use: Apply an appropriate amount to the skin evenly.

DOSAGE AND ADMINISTRATION

How to Use: Apply an appropriate amount to the skin evenly.

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE FOUNDATION  SPF31 PA PLUS PLUS NO 21
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-202
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	3.65 mg  in 35 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.4 mg  in 35 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.34 mg  in 35 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Diphenylsiloxy Phenyl Trimethicone (UNII: I445L28B12)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-202-01	35 mL in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2013

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

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

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	manufacture(51346-202)