PROVENCE CALENDULA FRESH SUN GE L by NATURE REPUBLIC CO., LTD. / Kolmar Korea Co., Ltd.

PROVENCE CALENDULA FRESH SUN GE L by

Drug Labeling and Warnings

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

Drug Details [pdf]

PROVENCE CALENDULA FRESH SUN GE L- 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 ingredients: 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] Daily gel-type sun block leaves skin light and fresh.

CAUTIONS

CAUTIONS: For external use only. Avoid contact with eyes and mouth. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace the cap after use.

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 GE L 
octinoxate, octisalate gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51346-450
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate3.42 g  in 57 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.71 g  in 57 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51346-450-021 in 1 CARTON02/01/201511/01/2019
1NDC: 51346-450-0157 mL in 1 CONTAINER; Type 0: Not a Combination Product
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
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(51346-450)

Revised: 2/2020
Document Id: ebd577fe-ba2e-44af-bcf8-8d35fe4d4515
Set id: 4212e92b-7ecc-49a4-9d1b-4cc3c098019b
Version: 2
Effective Time: 20200220
 
NATURE REPUBLIC CO., LTD.