PROVENCE CALENDULA SUN- zinc oxide, titanium dioxide liquid 
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: ZINC OXIDE 12.48%, TITANIUM DIOXIDE 2.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: CYCLOPENTASILOXANE, WATER, ISODODECANE, BUTYLENE GLYCOL,DICAPRYLYL ETHER,GLYCERIN,METHYL METHACRYLATE CROSSPOLYMER, ALCOHOL,BIOSACCHARIDE GUM-1,CAPRYLYL METHICONE,NIACINAMIDE,CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE,PEG-10 DIMETHICONE,POLYMETHYLSILSESQUIOXANE,DIMETHICONE,MAGNESIUM SULFATE,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,PORTULACA OLERACEA EXTRACT,METHICONE,SILICA,PHENOXYETHANOL,POLYGLYCERYL-6 POLYRICINOLEATE,ALUMINUM HYDROXIDE,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,FRAGRANCE,CAPRYLYL GLYCOL,STEARIC ACID,GLYCERYL CAPRYLATE,TOCOPHERYL ACETATE,ADENOSINE,POLYURETHANE-11,CALENDULA OFFICINALIS FLOWER EXTRACT

PURPOSE

Purpose: Sunscreen [UV Protection]

CAUTIONS

CAUTIONS: 1. For external use only. 2. Discontinue use if signs of irritation or rashes appear. 3. Keep out of reach of children 4. Replace the cap after use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

HOW TO USE

HOW TO USE: Shake the product 3-5 times before use. Then evenly apply an appropriate amount on areas exposed to UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

PROVENCE CALENDULA SUN 
zinc oxide, titanium dioxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-287
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION6.24 mg  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.00 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ISODODECANE (UNII: A8289P68Y2)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51346-287-0150 mL in 1 CARTON; Type 0: Not a Combination Product02/01/201512/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201512/30/2019
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIBusiness Operations
Kolmar Korea Co.,LTD. Gwanjeong Factory689512611manufacture(51346-287)

Revised: 7/2021
Document Id: 68b10ae0-5d35-49eb-a8b6-4189fc2d04c2
Set id: aa8ddba3-4906-4e3b-b049-f61bacc25261
Version: 2
Effective Time: 20210705
 
NATURE REPUBLIC CO., LTD.