PROVENCE CALENDULA WATERPROOF SUN BLOCK- zinc oxide, octinoxate, titanium dioxide, 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: ZINC OXIDE 13.82%, ETHYLHEXYL METHOXYCINNAMATE 6.80%, TITANIUM DIOXIDE 5.66%, ETHYLHEXYL SALICYLATE 4.50%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER,CYCLOPENTASILOXANE, DIPROPYLENE GLYCOL,PEG-10 DIMETHICONE,CAPRYLYL METHICONE,GLYCERIN,DIMETHICONE,DISTEARDIMONIUM HECTORITE,MAGNESIUM SULFATE,ALUMINUM HYDROXIDE,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,PORTULACA OLERACEA EXTRACT,BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE,STEARIC ACID,PHENOXYETHANOL,POLYGLYCERYL-6 POLYRICINOLEATE,POLYMETHYLSILSESQUIOXANE,SILICA,METHICONE,CAPRYLYL GLYCOL,DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER,FRAGRANCE,PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE,TRIETHOXYCAPRYLYLSILANE,OCTYLDODECANOL,MICROCRYSTALLINE CELLULOSE,ALOE BARBADENSIS LEAF JUICE,GLYCERYL CAPRYLATE,TOCOPHERYL ACETATE,BUTYLENE GLYCOL,EUTERPE OLERACEA FRUIT EXTRACT,MALPIGHIA EMARGINATA (ACEROLA) FRUIT EXTRACT,TERMINALIA FERDINANDIANA FRUIT EXTRACT,ECHIUM PLANTAGINEUM SEED OIL,CELLULOSE GUM,POLYURETHANE-11,CALENDULA OFFICINALIS FLOWER EXTRACT,CHAMOMILLA RECUTITA (MATRICARIA) FLOWER/LEAF EXTRACT,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. 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

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 WATERPROOF SUN BLOCK
zinc oxide, octinoxate, titanium dioxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:51346-290
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7.87 mg in 57 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.87 mg in 57 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.22 mg in 57 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.56 mg in 57 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:51346-290-01	57 mL in 1 CARTON; Type 0: Not a Combination Product	02/01/2015	12/30/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2015	12/30/2019

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

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

Name	Address	ID/FEI	Business Operations
Establishment
Kolmar Korea Co.,LTD. Gwanjeong Factory		689512611	manufacture(51346-290)

Revised: 7/2021

Document Id: 8a3cfe39-ff96-4b99-aa72-bfaf16c2f643

Set id: 65a97773-8aa2-45fb-b8e7-4af98fd18245

Version: 2

Effective Time: 20210705

NATURE REPUBLIC CO., LTD.