PROVENCE CALENDULA AQUA SUN- octinoxate, octisalate, homosalate gel

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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: ETHYLHEXYL METHOXYCINNAMATE 6.50%, ETHYLHEXYL SALICYLATE 4.40%, HOMOSALATE 4.40%

INACTIVE INGREDIENT

Inactive Ingredients: WATER, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE,DICAPRYLYL CARBONATE,ALCOHOL DENAT.,BUTYLENE GLYCOL,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE,BEHENYL ALCOHOL,FRAGRANCE(PARFUM),TRIETHANOLAMINE,GLYCERYL CAPRYLATE,PHENOXYETHANOL,CARBOMER,CAPRYLYL GLYCOL,ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,DISODIUM EDTA,CALENDULA OFFICINALIS FLOWER EXTRACT,ANTHEMIS NOBILIS FLOWER WATER,SODIUM BENZOATE,CITRIC ACID,POTASSIUM SORBATE

PURPOSE

Purpose: Sunscreen [UV Protection]

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

HOW TO USE

HOW TO USE: Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PROVENCE CALENDULA AQUA SUN 
octinoxate, octisalate, homosalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-283
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.25 mg  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.20 mg  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	2.20 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-283-01	50 mL in 1 CARTON; 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	02/01/2015

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

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

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	manufacture(51346-283)