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.

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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

Image of cartonImage of carton

PROVENCE CALENDULA MILD SUN BLOCK 
octinoxate, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51346-286
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.87 mg  in 57 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.56 mg  in 57 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.67 mg  in 57 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51346-286-0157 mL in 1 CARTON; Type 0: Not a Combination Product02/01/201511/01/2019
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
NATURE REPUBLIC CO., LTD.631172020manufacture(51346-286)

Revised: 2/2020
 
NATURE REPUBLIC CO., LTD.