PROVENCE CALENDULA AQUA SUN- octinoxate, octinoxate stick

PROVENCE CALENDULA AQUA SUN by

Drug Labeling and Warnings

PROVENCE CALENDULA AQUA SUN 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: ETHYLHEXYL METHOXYCINNAMATE 7.00%, ETHYLHEXYL SALICYLATE 4.50%

INACTIVE INGREDIENT

Inactive ingredients: OCTYLDODECANOL,CAPRYLIC/CAPRIC TRIGLYCERIDE,DICAPRYLYL CARBONATE,OCTOCRYLENE,ETHYLHEXYL METHOXYCINNAMATE,DIBUTYL LAUROYL GLUTAMIDE,ETHYLHEXYL SALICYLATE,SILICA SILYLATE,DIBUTYL ETHYLHEXANOYL GLUTAMIDE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE,DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE,TOCOPHERYL ACETATE,FRAGRANCE,BISABOLOL,HYDROXYACETOPHENONE,ECHIUM PLANTAGINEUM SEED OIL,WATER,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES,CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT,ALOE BARBADENSIS LEAF JUICE,BUTYLENE GLYCOL,PROPYLENE GLYCOL,MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT,TERMINALIA FERDINANDIANA FRUIT EXTRACT,EUTERPE OLERACEA FRUIT EXTRACT,TOCOPHEROL,CALENDULA OFFICINALIS FLOWER EXTRACT,PHENOXYETHANOL,CHAMOMILLA RECUTITA (MATRICARIA) FLOWER/LEAF EXTRACT,ETHYLHEXYLGLYCERIN,POTASSIUM SORBATE,SODIUM BENZOATE

PURPOSE

Purpose: Sunscreen

WARNINGS

Warnings: 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.

DESCRIPTION

Indications & Usage: The convenient sun stick creates smooth and clear UV protection layer over skin.

Dosage & Administration: Use at the last stage of your skincare routine. Turn the dial to expose the content for use, apply an appropriate amount all over the face, and lightly spread inward to outward. * Pat lightly when applying over makeup.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE CALENDULA AQUA SUN 
octinoxate, octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-433
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	1.05 g  in 15 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.67 g  in 15 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECANOL (UNII: 461N1O614Y)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-433-02	1 in 1 CARTON	12/01/2016
1	NDC: 51346-433-01	15 g in 1 BOTTLE, PLASTIC; 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	12/01/2016

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(51346-433)

Establishment
Name	Address	ID/FEI	Business Operations
Kolmar Korea Co., Ltd.		689847167	manufacture(51346-433)