PROVENCE CALENDULA PERFECT 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.

----------

ACTIVE INGREDIENT

ACTIVE INGREDIENTS: ETHYLHEXYL METHOXYCINNAMATE 7.50%, TITANIUM DIOXIDE (CI 77891) 4.25%, BUTYL METHOXYDIBENZOYLMETHANE 2.50%, ETHYLHEXYL SALICYLATE 2.00%, OCTOCRYLENE 2.00%

INACTIVE INGREDIENT

INACTIVE INGREDIENTS: WATER, BUTYLENE GLYCOL,ETHYLHEXYL PALMITATE,CYCLOPENTASILOXANE, GLYCERIN,4-METHYLBENZYLIDENE CAMPHOR, CYCLOHEXASILOXANE,NEOPENTYL GLYCOL DIHEPTANOATE, ALCOHOL DENAT.,CETEARYL ALCOHOL,GLYCERYL STEARATE,PEG-100 STEARATE,TRICETEARETH-4 PHOSPHATE,GLYCOL STEARATE,SILICA,SORBITAN SESQUIOLEATE,POTASSIUM CETYL PHOSPHATE,PEG-2 STEARATE,FRAGRANCE(PARFUM),ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER,GLYCERYL CAPRYLATE,PHENOXYETHANOL,TROMETHAMINE,CAPRYLYL GLYCOL,DIMETHICONE,XANTHAN GUM,DISODIUM EDTA,CALENDULA OFFICINALIS FLOWER EXTRACT,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 PERFECT SUN BLOCK 
octinoxate, titanium dioxide, avobenzone, octisalate, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51346-289
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE11.25 mg  in 150 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE6.37 mg  in 150 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.75 mg  in 150 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.00 mg  in 150 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3.00 mg  in 150 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51346-289-01150 mL in 1 CARTON; Type 0: Not a Combination Product02/01/201512/30/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35202/01/201512/30/2019
Labeler - NATURE REPUBLIC CO., LTD. (631172020)
Registrant - NATURE REPUBLIC CO., LTD. (631172020)
Establishment
NameAddressID/FEIBusiness Operations
Cosmax, Inc.689049693manufacture(51346-289)

Revised: 7/2021
Document Id: 6aa91d56-17e9-4dc2-9b9f-ea85618eef16
Set id: 0c063814-a1ff-4604-805f-d27b3903e95d
Version: 2
Effective Time: 20210705
 
NATURE REPUBLIC CO., LTD.