PROVENCE CALENDULA MILD SUN BLOCK by NATURE REPUBLIC CO., LTD.

PROVENCE CALENDULA MILD SUN BLOCK by

Drug Labeling and Warnings

PROVENCE CALENDULA MILD 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 MILD SUN BLOCK- octinoxate, octisalate, titanium dioxide 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.

----------

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: ETHYLHEXYL METHOXYCINNAMATE 6.80%, ETHYLHEXYL SALICYLATE 4.50%, TITANIUM DIOXIDE 1.19%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER, HOMOSALATE,DICAPRYLYL CARBONATE,CYCLOPENTASILOXANE,DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE,DIPROPYLENE GLYCOL,GLYCERYL STEARATE,PEG-100 STEARATE,1,2-HEXANEDIOL,BUTYLENE GLYCOL,C12-20 ALKYL GLUCOSIDE,C14-22 ALCOHOLS,CETEARYL ALCOHOL,VISCUM ALBUM (MISTLETOE) LEAF EXTRACT,CENTELLA ASIATICA EXTRACT,PORTULACA OLERACEA EXTRACT,SILICA,PHENOXYETHANOL,FRAGRANCE,OLETH-10,ALUMINUM STEARATE,OCTYLDODECANOL,ISODECETH-6,HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER,POLYACRYLATE-13,ALLANTOIN,GLYCINE SOJA (SOYBEAN) LIPIDS,XANTHAN GUM,POLYISOBUTENE,POLYSORBATE 20,ALUMINA,POLYURETHANE-11,ECHIUM PLANTAGINEUM SEED OIL,SIMETHICONE,ANTHEMIS NOBILIS FLOWER WATER,CALENDULA OFFICINALIS FLOWER EXTRACT,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 MILD SUN BLOCK 
octinoxate, octisalate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51346-286
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.56 mg  in 57 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.67 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: 51346-286-01	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(51346-286)

Revised: 2/2020

Document Id: 309163e5-f25b-45db-81f8-2bce2b27adff

34390-5

Set id: 2e601c3d-b075-43c3-9d8f-8826f084f6ed

Version: 2

Effective Time: 20200220

 

NATURE REPUBLIC CO., LTD.