PROVENCE AIR SKIN FIT ONE DAY LASTING FOUNDATION Y21 PURE VANILLA- titanium dioxide, octinoxate, zinc oxide cream

PROVENCE AIR SKIN FIT ONE DAY LASTING FOUNDATION Y21 PURE VANILLA by

Drug Labeling and Warnings

PROVENCE AIR SKIN FIT ONE DAY LASTING FOUNDATION Y21 PURE VANILLA 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 12.30%, Ethylhexyl Methoxycinnamate 4.00%, Zinc Oxide 0.97%

INACTIVE INGREDIENT

Inactive ingredients:

Water, Cyclopentasiloxane, Ethylhexyl Palmitate, Butylene Glycol, Phenyl Trimethicone, Isododecane, Polyglyceryl Diisostearate, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Diphenylsiloxy Phenyl Trimethicone, Niacinamide, Pentylene Glycol,Iron Oxides (CI 77492), Glycerin,Synthetic Fluorphlogopite, Magnesium Stearate, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Magnesium Sulfate, Disteardimonium Hectorite, Phenoxyethanol, PEG-30 Dipolyhydroxystearate, Bis-PEG/PPG-14/14 Dimethicone, Beeswax, Triethoxycaprylylsilane, Aluminum Hydroxide, Iron Oxides (CI 77491), Propylene Carbonate, Dimethicone/Vinyl Dimethicone Crosspolymer, Stearic Acid, Fragrance(Parfum), Iron Oxides (CI 77499), Ethylhexylglycerin, Adenosine, Disodium EDTA, Dimethicone, 1,2-Hexanediol, Tocopherol, Hibiscus Sabdariffa Flower Extract, Rosa Canina Fruit Extract, Lavandula Angustifolia (Lavender) Flower Extract, Lippia Citriodora Leaf Extract, Melissa Officinalis Extract, Mentha Piperita (Peppermint) Leaf Extract, Rosa Damascena Flower Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Leaf Extract, Tilia Europaea Flower Extract

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 long-lasting foundation provides 24-hour closely adhering cover

Directions:

Fully shake the container up and down before use. Gently apply an appropriate amount on the face in the direction of skin texture with your hand or the applicator.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE AIR SKIN FIT ONE DAY LASTING FOUNDATION Y21 PURE VANILLA 
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-505
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	Titanium Dioxide	3.69 g  in 30 mL
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.20 g  in 30 mL
Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.29 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Ethylhexyl Palmitate (UNII: 2865993309)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-505-02	1 in 1 CARTON	03/01/2018
1	NDC: 51346-505-01	30 mL in 1 CONTAINER; 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	03/01/2018

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Cosmax, Inc.		689049693	manufacture(51346-505)