CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (LIGHT 1) - BEIGE- octinoxate powder CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (LIGHT 2) - BEIGE- octinoxate powder CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (MEDIUM 1) - BEIGE- octinoxate powder CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (MEDIUM 2) - BEIGE- octinoxate powder CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (MEDIUM 3) - BEIGE- octinoxate powder CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (MEDIUM 4) - BROWN- octinoxate powder CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 (OBSCURE 1) - BROWN- octinoxate powder

CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 by

Drug Labeling and Warnings

CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20 by is a Otc medication manufactured, distributed, or labeled by Ventura Corporation LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OCTINOXATE 5.00%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.

Warnings

• Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
• For external use only.

• Do not use on damaged or broken skin.

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

• Stop use and ask a doctor if rash occurs.

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

Directions

• 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.

Inactive ingredients

MICA, TALC, ZINC STEARATE, BORON NITRIDE, DIMETHICONE, OCTYLDODECANOL, TRIMETHYLSILOXYSILICATE, METHYL METHACRYLATE CROSSPOLYMER, PERFLUOROOCTYL TRIETHOXYSILANE, TOCOPHERYL ACETATE, MAGNESIUM MYRISTATE, PHENOXYETHANOL, CAPRYLYL GLYCOL, FRAGRANCE, CHLORPHENESIN.

MAY CONTAIN:
TITANIUM DIOXIDE, IRON OXIDES.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (LIGHT 1) - BEIGE

cy°zone

STUDIO
LOOK
cy°zone

POLVOS COMPACTOS DE ALTA
COBERTURA CON FPS 20

Net Wt. 0.24 oz. (7g.)

PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (LIGHT 2) - BEIGE

cy°zone

STUDIO
LOOK
cy°zone

POLVOS COMPACTOS DE ALTA
COBERTURA CON FPS 20

Net Wt. 0.24 oz. (7g.)

PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 1) - BEIGE

cy°zone

STUDIO
LOOK
cy°zone

POLVOS COMPACTOS DE ALTA
COBERTURA CON FPS 20

Net Wt. 0.24 oz. (7g.)

PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 2) - BEIGE

cy°zone

STUDIO
LOOK
cy°zone

POLVOS COMPACTOS DE ALTA
COBERTURA CON FPS 20

Net Wt. 0.24 oz. (7g.)

PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 3) - BEIGE

cy°zone

STUDIO
LOOK
cy°zone

POLVOS COMPACTOS DE ALTA
COBERTURA CON FPS 20

Net Wt. 0.24 oz. (7g.)

PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (MEDIUM 4) - BROWN

cy°zone

STUDIO
LOOK
cy°zone

POLVOS COMPACTOS DE ALTA
COBERTURA CON FPS 20

Net Wt. 0.24 oz. (7g.)

PRINCIPAL DISPLAY PANEL - 7 g Tube Box - (OBSCURE 1) - BROWN

cy°zone

STUDIO
LOOK
cy°zone

POLVOS COMPACTOS DE ALTA
COBERTURA CON FPS 20

Net Wt. 0.24 oz. (7g.)

INGREDIENTS AND APPEARANCE

CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (LIGHT 1) - BEIGE
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-482
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-482-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/24/2015

CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (LIGHT 2) - BEIGE
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-483
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-483-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/24/2015

CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (MEDIUM 1) - BEIGE
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-484
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-484-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/24/2015

CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (MEDIUM 2) - BEIGE
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-485
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-485-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/24/2015

CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (MEDIUM 3) - BEIGE
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-486
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-486-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/24/2015

CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (MEDIUM 4) - BROWN
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-487
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-487-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/24/2015

CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20   (OBSCURE 1) - BROWN
octinoxate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 13537-488
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.05 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
TALC (UNII: 7SEV7J4R1U)
ZINC STEARATE (UNII: H92E6QA4FV)
BORON NITRIDE (UNII: 2U4T60A6YD)
DIMETHICONE (UNII: 92RU3N3Y1O)
OCTYLDODECANOL (UNII: 461N1O614Y)
PERFLUOROOCTYL TRIETHOXYSILANE (UNII: 814P46684U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
MAGNESIUM MYRISTATE (UNII: Z1917F0578)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHLORPHENESIN (UNII: I670DAL4SZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 13537-488-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/24/2015

Labeler - Ventura Corporation LTD (602751344)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(13537-482, 13537-483, 13537-484, 13537-485, 13537-486, 13537-487, 13537-488)