PROVENCE CALENDULA NO SEBUM SUN BLOCK by NATURE REPUBLIC 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.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROVENCE CALENDULA NO SEBUM SUN BLOCK- 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]

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: Take an adequate amount of the product and thoroughly apply on the areas exposed to the UV rays.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROVENCE CALENDULA NO SEBUM SUN BLOCK 
octinoxate, titanium dioxide, zinc oxide, octisalate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-288
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3.87 mg  in 57 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.95 mg  in 57 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.85 mg  in 57 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.56 mg  in 57 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51346-288-01	57 mL in 1 CARTON; Type 0: Not a Combination Product	02/01/2015	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	02/01/2015	11/01/2019

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

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

Establishment
Name	Address	ID/FEI	Business Operations
NATURE REPUBLIC CO., LTD.		631172020	manufacture(51346-288)

Revised: 2/2020

Document Id: fd34b0ae-2f62-4001-8ff3-ee578f8905d9

34390-5

Set id: dad6fe0e-480b-493b-9857-e1375aca073b

Version: 2

Effective Time: 20200220

 

NATURE REPUBLIC CO., LTD.