PROVENCE CALENDULA DAILY SUN BLOCK- 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 [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 DAILY SUN BLOCK 
octinoxate, titanium dioxide, avobenzone, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-284
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4.27 mg  in 57 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3.39 mg  in 57 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.42 mg  in 57 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE1.14 mg  in 57 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.14 mg  in 57 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51346-284-0157 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(51346-284)

Revised: 2/2020
Document Id: f99390df-cd24-40e3-96e4-3a09997a383b
Set id: 023dfed8-9787-459d-90dd-1c6b0c6d6d18
Version: 2
Effective Time: 20200220
 
NATURE REPUBLIC CO., LTD.