LBEL  DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION CLAIRE 1-2-3- titanium dioxide, zinc oxide, and octinoxate powder 
LBEL  DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION CLAIRE 4- titanium dioxide, zinc oxide, and octinoxate powder 
LBEL  DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 5- titanium dioxide, zinc oxide, and octinoxate powder 
LBEL  DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 6- titanium dioxide, zinc oxide, and octinoxate powder 
LBEL  DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 7- titanium dioxide, zinc oxide, and octinoxate powder 
LBEL  DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION OBSCURE 8-9- titanium dioxide, zinc oxide, and octinoxate powder 
Ventura Corporation 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.

----------

L'BEL
DIVINE Polvos compactos doble uso FPS 15 edicion de lujo plateado/Double use compact SPF 15 silver deluxe edition

Drug Facts

Active Ingredients

TITANIUM DIOXIDE (6.2393%), ZINC OXIDE (4.9%), OCTINOXATE (3.0%)

Purpose

Sunscreen

Uses

Warnings

Skin Cancer / Skin Aging Alert

Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

  • For external use only.

  • Do not use on damage or broken skin.

  • When using this product keep out of eyes. Rinse with water to remove.

  • Stop use and ask a doctor if rash occurs.

  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

MICA, POLYMETHYLSILSESQUIOXANE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, DIMETHICONE, MAGNESIUM STEARATE, TRIMETHYLSILOXYSILICATE, ISOSTEARYL NEOPENTANOATE, HYDROGEN DIMETHICONE, TOCOPHERYL ACETATE, PHENOXYETHANOL, ALUMINA, TRIETHOXYCAPRYLYLSILANE, PARFUM (FRAGRANCE), CAPRYLYL GLYCOL, CERAMIDE 3, CHLORPHENESIN. MAY CONTAIN: CI 77492 (IRON OXIDES), CI 77491 (IRON OXIDES), CI 77891 (TITANIUM DIOXIDE ), CI 77499 (IRON OXIDES).

PUERTO RICO: Dist by Ventura Corp, Ltd., San Juan, Puerto Rico 00926. Made in Colombia.

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Claire 1-2-3

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

Principal Display Panel - 10 g Cartridge Box - Claire 1-2-3

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Claire 4

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

Principal Display Panel - 10 g Cartridge Box - Claire 4

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 5

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

Principal Display Panel - 10 g Cartridge Box - Medium 5

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 6

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

Principal Display Panel - 10 g Cartridge Box - Medium 6

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Medium 7

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

Principal Display Panel - 10 g Cartridge Box - Medium 7

PRINCIPAL DISPLAY PANEL - 10 g Cartridge Box - Obscure 8-9

DIVINE

Polvos compactos doble uso FPS 15 edición de lujo plateado

Double use compact SPF 15 silver deluxe edition

10 g e (.35 oz.)

L'BEL

Principal Display Panel - 10 g Cartridge Box - Obscure 8-9
LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION CLAIRE 1-2-3
titanium dioxide, zinc oxide, and octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-493
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE 3 (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorRED (Rose) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-493-021 in 1 BOX
1NDC:13537-493-0110 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/27/2013
LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION CLAIRE 4
titanium dioxide, zinc oxide, and octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-494
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE 3 (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorRED (Rose lightly yellowish) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-494-021 in 1 BOX
1NDC:13537-494-0110 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/27/2013
LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 5
titanium dioxide, zinc oxide, and octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-495
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE 3 (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-495-021 in 1 BOX
1NDC:13537-495-0110 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/27/2013
LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 6
titanium dioxide, zinc oxide, and octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-496
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE 3 (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Yellowish Beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-496-021 in 1 BOX
1NDC:13537-496-0110 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/27/2013
LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION MEDIUM 7
titanium dioxide, zinc oxide, and octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-497
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE 3 (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Light Reddish Beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-497-021 in 1 BOX
1NDC:13537-497-0110 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/27/2013
LBEL   DIVINE POLVOS COMPACTOS DOBLE USO FPS 15 EDICION DE LUJO PLATEADO/DOUBLE USE COMPACT SPF 15 SILVER DELUXE EDITION OBSCURE 8-9
titanium dioxide, zinc oxide, and octinoxate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:13537-498
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide0.062393 g  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide0.049 g  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate0.03 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MICA (UNII: V8A1AW0880)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
CERAMIDE 3 (UNII: 4370DF050B)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
Product Characteristics
ColorBROWN (Reddish Beige) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13537-498-021 in 1 BOX
1NDC:13537-498-0110 g in 1 CARTRIDGE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/27/2013
Labeler - Ventura Corporation LTD. (602751344)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197MANUFACTURE(13537-493, 13537-494, 13537-495, 13537-496, 13537-497, 13537-498)

Revised: 5/2013
Document Id: d559a821-7a1b-4251-9f9f-c69daf4542d4
Set id: e8ed0ddb-a0af-4f0c-8c09-ae56ea5cf6a8
Version: 1
Effective Time: 20130529
 
Ventura Corporation LTD.