PROVENCE CALENDULA FRESH SUN by NATURE REPUBLIC CO., LTD.

PROVENCE CALENDULA FRESH SUN by

Drug Labeling and Warnings

PROVENCE CALENDULA FRESH SUN by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 cartonImage of carton

PROVENCE CALENDULA FRESH SUN 
octinoxate, octisalate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51346-285
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.42 mg  in 57 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.71 mg  in 57 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51346-285-0157 mL in 1 CARTON; Type 0: Not a Combination Product02/01/201511/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201511/01/2019
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIBusiness Operations
NATURE REPUBLIC CO., LTD.631172020manufacture(51346-285)

Revised: 2/2020