PROVENCE CALENDULA NO SEBUM SUN BLOCK by NATURE REPUBLIC CO., LTD. / Kolmar Korea Co., Ltd.

PROVENCE CALENDULA NO SEBUM SUN BLOCK by

Drug Labeling and Warnings

PROVENCE CALENDULA NO SEBUM SUN BLOCK 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 NO SEBUM SUN BLOCK SPF45- octinoxate, titanium dioxide, zinc oxide, octisalate cream 
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 6.80%, TITANIUM DIOXIDE 5.18%, ZINC OXIDE 5.00%, ETHYLHEXYL SALICYLATE 4.50%

INACTIVE INGREDIENT

Inactive Ingredients: WATER,CYCLOPENTASILOXANE,DIPROPYLENE GLYCOL,METHYL METHACRYLATE CROSSPOLYMER,PEG-10 DIMETHICONE,DIMETHICONE,DICAPRYLYL CARBONATE,MICA,DISTEARDIMONIUM HECTORITE,GLYCERIN,POLYMETHYL METHACRYLATE,MAGNESIUM SULFATE,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,PORTULACA OLERACEA EXTRACT,ALUMINUM HYDROXIDE,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE,PHENOXYETHANOL,VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER,STEARIC ACID,TALC,FRAGRANCE,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,METHICONE,CAPRYLYL GLYCOL,POLYGLYCERYL-6 POLYRICINOLEATE,OCTYLDODECANOL,MICROCRYSTALLINE CELLULOSE,GLYCERYL CAPRYLATE,TRIETHOXYCAPRYLYLSILANE,ECHIUM PLANTAGINEUM SEED OIL,CELLULOSE GUM,CALENDULA OFFICINALIS FLOWER EXTRACT,IRON OXIDES(CI 77491),CARDIOSPERMUM HALICACABUM FLOWER/LEAF/VINE EXTRACT,HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL UNSAPONIFIABLES

PURPOSE

Purpose: Sunscreen [UV PROTECTION] A moisture-rich daily sun block. Air-light, matte-finish oil sunblock.

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 NO SEBUM SUN BLOCK  SPF45
octinoxate, titanium dioxide, zinc oxide, octisalate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51346-448
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.87 g  in 57 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.95 g  in 57 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION2.85 g  in 57 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.56 g  in 57 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51346-448-021 in 1 CARTON02/01/201511/01/2019
1NDC: 51346-448-0157 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(51346-448)

Revised: 2/2020
Document Id: 3cf46327-16a7-4e95-adb1-989329cf0ff5
Set id: bb11d58e-ed99-42e5-9b74-2a58a57911dc
Version: 2
Effective Time: 20200220