PROVENCE CALENDULA AQUA COOLING SUN- octinoxate, octisalate, ensulizole spray
NATURE REPUBLIC CO., LTD.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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ACTIVE INGREDIENT

ACTIVE INGREDIENTS: ETHYLHEXYL METHOXYCINNAMATE 2.10%, ETHYLHEXYL SALICYLATE 1.20%, PHENYLBENZIMIDAZOLE SULFONIC ACID 0.90%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: DIMETHYL ETHER,WATER,CYCLOPENTASILOXANE,DIPROPYLENE GLYCOL,BUTYLENE GLYCOL,ALCOHOL DENAT.,C12-15 ALKYL BENZOATE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE,NIACINAMIDE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE,TROMETHAMINE,DIETHOXYETHYL SUCCINATE,SILICA,CAPRYLYL GLYCOL,ETHYLHEXYLGLYCERIN,FRAGRANCE,POLOXAMER 184,TOCOPHERYL ACETATE,ANTHEMIS NOBILIS FLOWER WATER,CALENDULA OFFICINALIS FLOWER EXTRACT,PEG-60 HYDROGENATED CASTOR OIL,1,2-HEXANEDIOL,DISODIUM EDTA,ADENOSINE,SODIUM BENZOATE,CITRIC ACID,GLYCERYL CAPRYLATE,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

HOW TO USE

HOW TO USE: Shake the product well and evenly spray onto your body parts that are exposed to the sun. Spray in distance and gently pat for absorption if needed. Spray several times a day during outdoor activities.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of bottle

PROVENCE CALENDULA AQUA COOLING SUN
octinoxate, octisalate, ensulizole spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-282
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.15 mg in 150 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.80 mg in 150 mL
ENSULIZOLE (UNII: 9YQ9DI1W42) (ENSULIZOLE - UNII:9YQ9DI1W42)	ENSULIZOLE	1.35 mg in 150 mL

Ingredient Name	Strength
Inactive Ingredients
DIMETHYL ETHER (UNII: AM13FS69BX)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-282-01	150 mL in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2015	12/30/2017

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2015	12/30/2017

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Cosmecca Korea Co., Ltd.		688830827	manufacture(51346-282)

Revised: 8/2018

Document Id: 78d869f8-05c7-451d-b188-4e835a54e102

Set id: 84265f6f-be92-4d73-b257-cdaf04041ab8

Version: 2

Effective Time: 20180824

NATURE REPUBLIC CO., LTD.