PROVENCE CALENDULA DAILY SUN BLOCK by NATURE REPUBLIC CO., LTD. / Cosmax, Inc

PROVENCE CALENDULA DAILY SUN BLOCK by

Drug Labeling and Warnings

PROVENCE CALENDULA DAILY SUN BLOCK by is a Otc medication manufactured, distributed, or labeled by NATURE REPUBLIC CO., LTD., Cosmax, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROVENCE CALENDULA DAILY SUN BLOCK SPF50 PLUS- octinoxate, titanium dioxide, avobenzone, octisalate, octocrylene 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 7.50%, TITANIUM DIOXIDE (CI 77891) 5.95%, BUTYL METHOXYDIBENZOYLMETHANE 2.50%, ETHYLHEXYL SALICYLATE 2.00%, OCTOCRYLENE 2.00%

INACTIVE INGREDIENT

Inactive Ingredients: WATER,CYCLOPENTASILOXANE, GLYCERIN,ETHYLHEXYL PALMITATE,CYCLOHEXASILOXANE,4-METHYLBENZYLIDENE CAMPHOR,NIACINAMIDE,NEOPENTYL GLYCOL DIHEPTANOATE,BUTYLENE GLYCOL, SILICA,CETEARYL ALCOHOL,GLYCERYL STEARATE,PEG-100 STEARATE,TRICETEARETH-4 PHOSPHATE,GLYCOL STEARATE,SORBITAN SESQUIOLEATE,POTASSIUM CETYL PHOSPHATE,PEG-2 STEARATE,ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,FRAGRANCE(PARFUM),TROMETHAMINE,GLYCERYL CAPRYLATE,PHENOXYETHANOL,CAPRYLYL GLYCOL,DIMETHICONE,ADENOSINE,XANTHAN GUM,IRON OXIDES (CI 77492),DISODIUM EDTA,CALENDULA OFFICINALIS FLOWER EXTRACT,IRON OXIDES (CI 77491),ANTHEMIS NOBILIS FLOWER WATER,SODIUM BENZOATE,CITRIC ACID,POTASSIUM SORBATE,

PURPOSE

Purpose: [SUNSCREEN] A daily sunblock with soft texture.

CAUTIONS

CAUTIONS: For external use only. Avoid contact with eyes and mouth. Discontinue use if signs of irritation or rashes appear. Keep out of reach of children. Replace the cap after use.

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 DAILY SUN BLOCK  SPF50 PLUS
octinoxate, titanium dioxide, avobenzone, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 51346-451
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) Octinoxate4.27 g  in 57 mL
Titanium dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium dioxide3.39 g  in 57 mL
Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone1.42 g  in 57 mL
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate1.14 g  in 57 mL
Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene1.14 g  in 57 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 51346-451-021 in 1 CARTON02/01/201511/01/2019
1NDC: 51346-451-0157 mL in 1 CONTAINER; Type 0: Not a Combination Product
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
Cosmax, Inc.689049693manufacture(51346-451)

Revised: 2/2020
Document Id: 91117d66-78c6-43e3-9132-864cf3e4420b
Set id: b22d90bb-749e-41c8-96bc-994a351c65a7
Version: 2
Effective Time: 20200220