CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CANELA 280-F- octinoxate, zinc oxide emulsion 
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR MORENO 300-N- octinoxate, zinc oxide emulsion 
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 PANELA 320-C- octinoxate, zinc oxide emulsion 
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CACAO 350-N- octinoxate, zinc oxide emulsion 
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-C- octinoxate, zinc oxide emulsion 
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CHOCOTRUFA 430-N- octinoxate, zinc oxide emulsion 
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 BOMBON 400-N- octinoxate, zinc oxide emulsion 
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CHOCOCHIP 330-C- octinoxate, zinc oxide emulsion 
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 BROWNIE 380-F- octinoxate, zinc oxide emulsion 
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 ESPRESSO 450-C- octinoxate, zinc oxide emulsion 
BEL STAR S A

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.

----------

CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20

Drug Facts

Active Ingredients

Octinoxate 4.00%

Zinc Oxide 2.40%

Purpose

Sunscreen

Uses

Warnings

Do not use

on damaged 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:

water, dimethicone, peg-10 dimethicone, glycerin, isododecane, polymethylsilsesquioxane, trimethylsiloxysilicate, hdi/trimethylol hexyllactone crosspolymer, peg/ppg-18/18 dimethicone, silica, lecithin, silica dimethyl silylate, polypropylsilsesquioxane, polysilicone-11, sodium chloride, phenoxyethanol, jojoba esters, disteardimonium hectorite, tocopheryl acetate, dimethicone/vinyl dimethicone crosspolymer, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, helianthus annuus (sunflower) seed wax, hexyl laurate, caprylyl glycol, chlorphenesin, fragrance, acacia decurrens flower wax, polyglycerin-3, laureth-12, benzyl alcohol, linalool, hexyl cinnamal, limonene. May contain: titanium dioxide, iron oxides, triethoxycaprylylsilane.

Company Information

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

Made in Colombia.

www.cyzone.com

AVELLANA 270-C

1

9

CANELA 280-F

2

AZUCAR MORENO 300-N

3

PANELA 320-C

11

CHOCOCHIP 330-C

5

CACAO 350-N

1

1

BROWNIE 380-F

7

BOMBON 400-N

1

9

CHOCOTRUFA 430-N

9

ESPRESSO 450-C

10

CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CANELA 280-F 
octinoxate, zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ISODODECANE (UNII: A8289P68Y2)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
LAURETH-12 (UNII: OAH19558U1)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-034-011 in 1 BOX04/13/2022
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2022
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AZUCAR MORENO 300-N 
octinoxate, zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-035
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ISODODECANE (UNII: A8289P68Y2)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
LAURETH-12 (UNII: OAH19558U1)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-035-011 in 1 BOX04/13/2022
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2022
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 PANELA 320-C 
octinoxate, zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-036
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ISODODECANE (UNII: A8289P68Y2)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
LAURETH-12 (UNII: OAH19558U1)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-036-011 in 1 BOX04/13/2022
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2022
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CACAO 350-N 
octinoxate, zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-138
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ISODODECANE (UNII: A8289P68Y2)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
LAURETH-12 (UNII: OAH19558U1)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-138-011 in 1 BOX04/13/2022
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2022
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 AVELLANA 270-C 
octinoxate, zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-033
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ISODODECANE (UNII: A8289P68Y2)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
LAURETH-12 (UNII: OAH19558U1)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-033-011 in 1 BOX04/13/2022
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2022
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CHOCOTRUFA 430-N 
octinoxate, zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-141
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ISODODECANE (UNII: A8289P68Y2)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
LAURETH-12 (UNII: OAH19558U1)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-141-011 in 1 BOX04/13/2022
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2022
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 BOMBON 400-N 
octinoxate, zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-240
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ISODODECANE (UNII: A8289P68Y2)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
LAURETH-12 (UNII: OAH19558U1)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-240-011 in 1 BOX04/13/2022
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2022
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 CHOCOCHIP 330-C 
octinoxate, zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-037
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ISODODECANE (UNII: A8289P68Y2)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
LAURETH-12 (UNII: OAH19558U1)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-037-011 in 1 BOX04/13/2022
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2022
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 BROWNIE 380-F 
octinoxate, zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-139
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ISODODECANE (UNII: A8289P68Y2)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
LAURETH-12 (UNII: OAH19558U1)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-139-011 in 1 BOX04/13/2022
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2022
CYZONE STUDIO LOOK BASE DE ALTA COBERTURA Y LARGA DURACION FPS 20 ESPRESSO 450-C 
octinoxate, zinc oxide emulsion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14141-242
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE40 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE24 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)  
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
LIMONENE, (+/-)- (UNII: 9MC3I34447)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
ISODODECANE (UNII: A8289P68Y2)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
LAURETH-12 (UNII: OAH19558U1)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLSILSESQUIOXANE, HYDROGEN TERMINATED (UNII: 2PDG9JR76G)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5) (UNII: 035JKJ76MT)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14141-242-011 in 1 BOX04/13/2022
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/13/2022
Labeler - BEL STAR S A (880160197)

Revised: 9/2023
Document Id: 066c10ae-f334-f3d6-e063-6294a90abfc1
Set id: dc25651b-0e30-c325-e053-2995a90a809e
Version: 3
Effective Time: 20230928
 
BEL STAR S A