PROVENCE CALENDULA AQUA SUN- octinoxate, octisalate, homosalate gel
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 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

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

Image of carton

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-283-01	50 mL in 1 CARTON; Type 0: Not a Combination Product	02/01/2015	12/30/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2015	12/30/2019

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Cosmax, Inc.		689049693	manufacture(51346-283)

Revised: 7/2021

Document Id: fda5d86b-4a6c-463b-84fb-64997e29e101

Set id: 8f4fc901-6e98-4dab-9aa5-3dd4c77ec24e

Version: 2

Effective Time: 20210705

NATURE REPUBLIC CO., LTD.