PROVENCE MAKEUP BASE SPF30 PA PLUS PLUS 02 LAVENDER- octinoxate, zinc oxide, titanium dioxide cream

PROVENCE MAKEUP BASE by

Drug Labeling and Warnings

PROVENCE MAKEUP BASE 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: Ethylhexyl Methoxycinnamate 5%, Zinc Oxide 4.9%, Titanium Dioxide 4.18%

INACTIVE INGREDIENT

Inactive Ingredients:
Water, Cyclopentasiloxane, Glycerin, Dicaprylyl Carbonate, Cyclohexasiloxane, Dimethicone, Dipropylene Glycol, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Butylene Glycol Dicaprylate/Dicaprate, Cetyl PEG/PPG-10/1 Dimethicone, Sorbitan Isostearate, Tribehenin,
Disteardimonium Hectorite, Magnesium Sulfate, Ultramarines (CI 77007), Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Ceresin, Aluminum Hydroxide, Stearic Acid, Fragrance(Parfum), Dimethicone Crosspolymer, Mica (CI 77019), Ethylhexylglycerin,
Triethoxycaprylylsilane, Adenosine, Disodium EDTA, Rosmarinus Officinalis (Rosemary) Leaf Extract, Rosa Canina Fruit Oil, Mentha Piperita (Peppermint) Oil, Butylene Glycol, Lavandula Angustifolia (Lavender) Flower Extract

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 MAKEUP BASE  SPF30 PA PLUS PLUS 02 LAVENDER
octinoxate, zinc oxide, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-205
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.75 mg  in 35 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	1.71 mg  in 35 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.46 mg  in 35 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: 51346-205-01	35 mL in 1 CARTON; Type 0: Not a Combination Product	02/01/2013

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
Cosmax, Inc.		689049693	manufacture(51346-205)