STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AZUCAR BLANCA 110-C- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AVELLANA 270-C- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHOCOTRUFA 430-N- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 VAINILLA 140-C- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 PANELA 320-C- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CACAO 350-N- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHANTILLY 130-F- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHOCOCHIP 330-C- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 NUEZ 180-F- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 TOFFEE 240-C- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 ESPRESSO 450-C- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 DULCE DE LECHE 260-N- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AZUCAR MORENO 300-N- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 BOMBON 400-N- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CANELA 280-F- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AVENA 170-N- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 MIEL 200-C- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 ALMENDRA 230-N- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 BROWNIE 380-F- octinoxate, zinc oxide cream 
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CARAMELO 210-F- octinoxate, zinc oxide cream 
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.

----------

Studio Look base de alta cobertura para el rostro con FPS 20

Active Ingredients Purpose

Octinoxate 4.00% Sunscreen

Zinc Oxide 2.40% Sunscreen

Uses

Helps Prevent Sunburn

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

Stop use and ask a doctor if rash occurs.

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.

Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove
For external use only

Directions

Apply liberally and evenly 15 minutes before sun exposure

Reapply at least every 2 hours.

Use a water-resistant sunscreen if swimming or sweating
Children under 6 months of age: ask a doctor.


Other information

Protect the product in this container from excessive heat and direct sun

Water, Dimethicone, PEG-10 Dimethicone, Glycerin, Isododecane, Polymethysilsesquioxane, Trimethysiloxysilicate, 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 Deccurens Flower Wax, Polyglycerin-3, Laureth-12, Benzyl Alcohol, Linalool, Hexyl Cinnamal, Limonene.
May Contain: Titanium Dioxide, Iron Oxides, Triethoxycaprylylsilane.

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Azucar Blanca
Net. Wt. 1.05 oz e(30 g)

Azucar Blanca 1

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Chantilly 130-F
Net. Wt. 1.05 oz e(30 g)

Chantilly 2

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Vainilla 140-C
Net. Wt. 1.05 oz e(30 g)

Vainilla 3

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Avena 170-N
Net. Wt. 1.05 oz e(30 g)

Avena

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Nuez 180-F
Net. Wt. 1.05 oz e(30 g)

Nuez 5

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Miel 200-C
Net. Wt. 1.05 oz e(30 g)

Miel 6

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Caramelo 210-F
Net. Wt. 1.05 oz e(30 g)

Caramello 7

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Almendra 230-N
Net. Wt. 1.05 oz e(30 g)

Almendra

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Toffee 240-C
Net. Wt. 1.05 oz e(30 g)

Toffee 9

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Dulce De Leche 260-N
Net. Wt. 1.05 oz e(30 g)

Dulce de leche 10

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Avellana 270-C
Net. Wt. 1.05 oz e(30 g)

Avellana 270-C

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Canela 280-F
Net. Wt. 1.05 oz e(30 g)

Canela 12

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Azucar Moreno 300-N
Net. Wt. 1.05 oz e(30 g)

Azucar Moreno 13

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Panela 320-C
Net. Wt. 1.05 oz e(30 g)

Panela 14

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Chocochip 330-C
Net. Wt. 1.05 oz e(30 g)

Chocochip 15

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Cacao 350-N
Net. Wt. 1.05 oz e(30 g)

Cacao 16

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Brownie 380-F
Net. Wt. 1.05 oz e(30 g)

Brownie 17

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Bombon 400-N
Net. Wt. 1.05 oz e(30 g)

Bombon 18

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Chocotrufa 430-N
Net. Wt. 1.05 oz e(30 g)

Chocotrufa 19

Cyzone
Studio Look
Base De Alta Cobertura Para El Rostro Con FPS 20 Espresso 450-C
Net. Wt. 1.05 oz e(30 g)

Espresso 20

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AZUCAR BLANCA 110-C 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0863
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0863-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AVELLANA 270-C 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0873
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0873-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHOCOTRUFA 430-N 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0881
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0881-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 VAINILLA 140-C 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0865
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0865-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 PANELA 320-C 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0876
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0876-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CACAO 350-N 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0878
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0878-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHANTILLY 130-F 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0864
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0864-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHOCOCHIP 330-C 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0877
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0877-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 NUEZ 180-F 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0867
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0867-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 TOFFEE 240-C 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0871
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0871-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 ESPRESSO 450-C 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0882
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0882-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 DULCE DE LECHE 260-N 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0872
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0872-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AZUCAR MORENO 300-N 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0875
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0875-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 BOMBON 400-N 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0880
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0880-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CANELA 280-F 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0874
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0874-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AVENA 170-N 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0866
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0866-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 MIEL 200-C 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0868
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0868-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 ALMENDRA 230-N 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0870
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0870-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 BROWNIE 380-F 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0879
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0879-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CARAMELO 210-F 
octinoxate, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43596-0869
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE4 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE2.4 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CHLORPHENESIN (UNII: I670DAL4SZ)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)  
HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
HEXYL LAURATE (UNII: 4CG9F9W01Q)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
ISODODECANE (UNII: A8289P68Y2)  
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I)  
ACACIA DECURRENS FLOWER WAX (UNII: AU6XZE9IY9)  
PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
WATER (UNII: 059QF0KO0R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
LAURETH-12 (UNII: OAH19558U1)  
LINALOOL, (+/-)- (UNII: D81QY6I88E)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43596-0869-130 g in 1 TUBE; Type 0: Not a Combination Product04/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35204/01/2020
Labeler - Ventura Corporation LTD (602751344)
Establishment
NameAddressID/FEIBusiness Operations
BEL STAR S A880160197manufacture(43596-0863, 43596-0864, 43596-0865, 43596-0866, 43596-0867, 43596-0868, 43596-0869, 43596-0870, 43596-0871, 43596-0872, 43596-0873, 43596-0874, 43596-0875, 43596-0876, 43596-0877, 43596-0878, 43596-0879, 43596-0880, 43596-0881, 43596-0882)

Revised: 7/2020
Document Id: aa553db9-db23-44e8-e053-2a95a90a3388
Set id: a4628b10-fc80-1b15-e053-2a95a90a2958
Version: 2
Effective Time: 20200713
 
Ventura Corporation LTD