PROVENCE CALENDULA FRESH SUN- octinoxate, octisalate 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 Ingredient: ETHYLHEXYL METHOXYCINNAMATE 6.00%, ETHYLHEXYL SALICYLATE 3.00%

INACTIVE INGREDIENT

Inactive Ingredients: WATER, BUTYLENE GLYCOL, CYCLOPENTASILOXANE,ALCOHOL, ISOAMYL P-METHOXYCINNAMATE,DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE,1,2-HEXANEDIOL,TRIETHANOLAMINE,DIPROPYLENE GLYCOL,PEG/PPG-30/10 DIMETHICONE,SILICA,CARBOMER,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,PORTULACA OLERACEA EXTRACT,CETETH-10,FRAGRANCE,PHENOXYETHANOL,BEHENYL ALCOHOL,ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,OCTYLDODECANOL,CALENDULA OFFICINALIS FLOWER EXTRACT,ECHIUM PLANTAGINEUM SEED OIL,SODIUM HYALURONATE,CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES

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 FRESH SUN
octinoxate, octisalate gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-285
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.42 mg in 57 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	1.71 mg in 57 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-285-01	57 mL in 1 CARTON; Type 0: Not a Combination Product	02/01/2015	11/01/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2015	11/01/2019

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

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

Name	Address	ID/FEI	Business Operations
Establishment
NATURE REPUBLIC CO., LTD.		631172020	manufacture(51346-285)

Revised: 2/2020

Document Id: c4afeff3-6559-40b5-88a6-ee49170f4ba9

Set id: 116a7fb1-d479-47fb-9486-ba3c8d383932

Version: 2

Effective Time: 20200220

NATURE REPUBLIC CO., LTD.