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
Bel Star S.A. (Colombia)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

CYZONE STUDIO LOOK POLVOS COMPACTOS DE ALTA COBERTURA CON FPS 20

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.

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 1) - BEIGE

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 - (LIGHT 2) - BEIGE

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 1) - BEIGE

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 2) - BEIGE

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 3) - BEIGE

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 - (MEDIUM 4) - BROWN

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.)

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

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:14141-482
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-482-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/24/2015	07/20/2023

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:14141-483
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-483-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/24/2015	01/29/2024

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:14141-484
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-484-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/24/2015	01/29/2024

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:14141-485
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-485-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/24/2015	02/08/2024

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:14141-486
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-486-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/24/2015	08/12/2023

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:14141-487
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-487-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/24/2015	07/17/2023

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:14141-488
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:14141-488-01	1 in 1 BOX	08/24/2015
1		7 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	08/24/2015	02/11/2023

Labeler - Bel Star S.A. (Colombia) (880160197)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	manufacture(14141-482, 14141-483, 14141-484, 14141-485, 14141-486, 14141-487, 14141-488)

Revised: 12/2022

Document Id: ef556ee7-7bd9-ac54-e053-2995a90a9578

Set id: 73970f80-d966-47ca-a4ad-f6be94381c9f

Version: 2

Effective Time: 20221208

Bel Star S.A. (Colombia)