PROVENCE INTENSIVE AMPOULE BB 02 NATURAL BEIGE- titanium dioxide, octinoxate, zinc oxide cream

PROVENCE INTENSIVE AMPOULE BB 02 NATURAL BEIGE by

Drug Labeling and Warnings

PROVENCE INTENSIVE AMPOULE BB 02 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 Ingredient: TITANIUM DIOXIDE 7.9%, ETHYLHEXYL METHOXYCINNAMATE 3.0%, ZINC OXIDE 1.9%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS:
WATER, CYCLOPENTASILOXANE, TALC, GLYCERIN, PEG-10 DIMETHICONE, NIACINAMIDE, DIPROPYLENE GLYCOL, ISOEICOSANE, CAPRYLYL METHICONE, TRIDECYL TRIMELLITATE, CYCLOMETHICONE, IRON OXIDES(CI 77492), DISTEARDIMONIUM HECTORITE, TRIETHYLHEXANOIN, HEXYL LAURATE, MAGNESIUM SULFATE, C12-14 PARETH-3, PHENOXYETHANOL, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, ACRYLATES/DIMETHICONE COPOLYMER, IRON OXIDES(CI 77491), METHICONE, VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER, SILICA, PALMITIC ACID, IRON OXIDES(CI 77499), ETHYLHEXYLGLYCERIN, TOCOPHERYL ACETATE, FRAGRANCE, ALUMINUM HYDROXIDE, ALUMINUM STEARATE, DIMETHICONE, ADENOSINE, SODIUM HYALURONATE, ALCOHOL, HYDROLYZED HYALURONIC ACID, PANAX GINSENG ROOT EXTRACT, LAVANDULA ANGUSTIFOLIA (LAVENDER) FLOWER WATER, BUTYLENE GLYCOL, ROYAL JELLY, FICUS CARICA (FIG) FRUIT EXTRACT, MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT, SALMON EGG EXTRACT, CARICA PAPAYA (PAPAYA) FRUIT, CORNUS OFFICINALIS FRUIT EXTRACT, LIPPIA CITRIODORA LEAF EXTRACT, CALENDULA OFFICINALIS FLOWER EXTRACT, SODIUM BENZOATE, CITRIC ACID, SILK AMINO ACIDS, PROPOLIS EXTRACT, OENOTHERA BIENNIS (EVENING PRIMROSE) OIL, SQUALANE, HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL

PURPOSE

Purpose: Sunscreen

WARNINGS

WARNINGS:
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.

DESCRIPTION

Indications & usage: The BB cream provides natural coverage with UV protection.

Dosage & administration: Apply an appropriate amount to the entire face.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE INTENSIVE AMPOULE BB 02 NATURAL BEIGE 
titanium dioxide, octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-520
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.95 g  in 50 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	1.50 g  in 50 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.95 g  in 50 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: 51346-520-02	1 in 1 CARTON	12/20/2016
1	NDC: 51346-520-01	50 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	12/20/2016

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689512611	manufacture(51346-520)