PROVENCE WATER DROP PACT 23 NATURAL BEIGE- titanium dioxide, octinoxate, octisalate, zinc oxide powder

PROVENCE WATER DROP PACT 23 NATURAL BEIGE by

Drug Labeling and Warnings

PROVENCE WATER DROP PACT 23 NATURAL BEIGE by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Kolmar Korea Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: TITANIUM DIOXIDE (6.39%), ETHYLHEXYL METHOXYCINNAMATE (6.00%), ETHYLHEXYL SALICYLATE (2.00%), ZINC OXIDE (1.92%)

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER, HEXYLDECYL MYRISTOYL METHYLAMINOPROPIONATE,DIISOPROPYL ADIPATE,EUPHORBIA CERIFERA (CANDELILLA) WAX,ISOEICOSANE,BUTYLENE GLYCOL, NIACINAMIDE, DIMETHICONE,SILICA,C30-45 ALKYL METHICONE,TALC,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,PORTULACA OLERACEA EXTRACT,IRON OXIDES(CI 77492),LAURYL PEG-8 DIMETHICONE,MYRISTYL MYRISTATE,SORBITAN SESQUIOLEATE,DIMETHICONE/PEG-10/15 CROSSPOLYMER,PHENOXYETHANOL,OCTYLDODECANOL,ALUMINUM HYDROXIDE,IRON OXIDES(CI 77491),ALUMINUM STEARATE,METHICONE,PECTIN,ETHYLHEXYLGLYCERIN,FRAGRANCE,AMINOPROPYL DIMETHICONE,POLYMETHYLSILSESQUIOXANE,IRON OXIDES(CI 77499),POLYURETHANE-11,ALUMINA,ADENOSINE,ECHIUM PLANTAGINEUM SEED OIL,TRIETHOXYCAPRYLYLSILANE,CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES,LEONTOPODIUM ALPINUM EXTRACT,RHODODENDRON FERRUGINEUM EXTRACT,RUBUS CHAMAEMORUS SEED EXTRACT,SEA WATER

PURPOSE

PURPOSE: [UV PROTECTION] This water-drop pact makes skin moist-full and provides natural coverage.

CAUTIONS

CAUTIONS: 1. For external use only 2. Avoid contact with eyes and mouth 3. Discontinue use if signs of irritation or rashes appear 4. Keep out of reach of children 5. Replace the cap after use

HOW TO USE

HOW TO USE: Dispense an appropriate amount onto the puff, and apply onto the skin in a gentle tapping motion.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE WATER DROP PACT 23 NATURAL BEIGE 
titanium dioxide, octinoxate, octisalate, zinc oxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-347
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.89 g  in 14 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.84 g  in 14 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	0.28 g  in 14 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.26 g  in 14 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-347-01	14 g in 1 CARTON; Type 0: Not a Combination Product	09/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/01/2015

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(51346-347)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(51346-347)