DailyMed - 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 .......0-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

Contains inactivated NDC Code(s)
NDC Code(s): 43596-0863-1, 43596-0864-1, 43596-0865-1, 43596-0866-1, view more
43596-0867-1, 43596-0868-1, 43596-0869-1, 43596-0870-1, 43596-0871-1, 43596-0872-1, 43596-0873-1, 43596-0874-1, 43596-0875-1, 43596-0876-1, 43596-0877-1, 43596-0878-1, 43596-0879-1, 43596-0880-1, 43596-0881-1, 43596-0882-1
Packager: Ventura Corporation LTD

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 13, 2020

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

View All Sections

ACTIVE INGREDIENT

Active Ingredients Purpose

Octinoxate 4.00% Sunscreen

Zinc Oxide 2.40% Sunscreen
PURPOSE

Uses

Helps Prevent Sunburn
KEEP OUT OF REACH OF CHILDREN

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

Stop use and ask a doctor if rash occurs.
WARNINGS

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
DOSAGE & ADMINISTRATION

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 SAFETY INFORMATION

Other information

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

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.
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Base De Alta Cobertura Para El Rostro Con FPS 20 Chantilly 130-F
Net. Wt. 1.05 oz e(30 g)
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Base De Alta Cobertura Para El Rostro Con FPS 20 Vainilla 140-C
Net. Wt. 1.05 oz e(30 g)
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Base De Alta Cobertura Para El Rostro Con FPS 20 Avena 170-N
Net. Wt. 1.05 oz e(30 g)
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Base De Alta Cobertura Para El Rostro Con FPS 20 Nuez 180-F
Net. Wt. 1.05 oz e(30 g)
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Base De Alta Cobertura Para El Rostro Con FPS 20 Miel 200-C
Net. Wt. 1.05 oz e(30 g)
PRINCIPAL DISPLAY PANEL

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

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

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

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

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

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

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

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

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

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

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

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

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

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

INGREDIENTS AND APPEARANCE

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AZUCAR BLANCA 110-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0863
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0863-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AVELLANA 270-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0873
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0873-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHOCOTRUFA 430-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0881
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0881-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 VAINILLA 140-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0865
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0865-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 PANELA 320-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0876
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0876-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CACAO 350-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0878
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0878-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHANTILLY 130-F
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0864
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0864-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CHOCOCHIP 330-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0877
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0877-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 NUEZ 180-F
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0867
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0867-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 TOFFEE 240-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0871
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0871-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 ESPRESSO 450-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0882
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0882-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 DULCE DE LECHE 260-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0872
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0872-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AZUCAR MORENO 300-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0875
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0875-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 BOMBON 400-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0880
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0880-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CANELA 280-F
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0874
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0874-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 AVENA 170-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0866
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0866-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 MIEL 200-C
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0868
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0868-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 ALMENDRA 230-N
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0870
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0870-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 BROWNIE 380-F
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0879
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0879-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

STUDIO LOOK BASE DE ALTA COBERTURA PARA EL ROSTRO CON FPS 20 CARAMELO 210-F
octinoxate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0869
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	4 g in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	2.4 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0869-1	30 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2020

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
BEL STAR S A		880160197	manufacture(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)

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Published Date (What is this?)	Version	Files
Dec 4, 2020	2 (current)	download
May 7, 2020	1	download

	NDC
1	43596-0863-1 (inactivated)
2	43596-0864-1 (inactivated)
3	43596-0865-1 (inactivated)
4	43596-0866-1 (inactivated)
5	43596-0867-1 (inactivated)
6	43596-0868-1 (inactivated)
7	43596-0869-1 (inactivated)
8	43596-0870-1 (inactivated)
9	43596-0871-1 (inactivated)
10	43596-0872-1 (inactivated)
11	43596-0873-1 (inactivated)
12	43596-0874-1 (inactivated)
13	43596-0875-1 (inactivated)
14	43596-0876-1 (inactivated)
15	43596-0877-1 (inactivated)
16	43596-0878-1 (inactivated)
17	43596-0879-1 (inactivated)
18	43596-0880-1 (inactivated)
19	43596-0881-1 (inactivated)
20	43596-0882-1 (inactivated)

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If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.