CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 RED/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 APPLE/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 ROSE/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 FUCSIA/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 GRAPE/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 CHOCOLATE/BROWN- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 MARSALA/RED- octinoxate lipstick
CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 ROSE NUDE/RED- octinoxate lipstick
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.

----------

CY° HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15

Drug Facts

Active Ingredients

OCTINOXATE 7.5%

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

RICINUS COMMUNIS (CASTOR) SEED OIL, OCTYLDODECANOL, POLYETHYLENE, BUTYROSPERMUM PARKII (SHEA) BUTTER, SYNTHETIC BEESWAX, COPERNICIA CERIFERA (CARNAUBA) WAX, DISTEARDIMONIUM HECTORITE, VITIS VINIFERA (GRAPE) SEED OIL, PROPYLENE CARBONATE, SILICA DIMETHYL SILYLATE, TOCOPHERYL ACETATE, PHENOXYETHANOL, FRAGRANCE, METHYLPROPANEDIOL, CAPRYLYL GLYCOL, SILANEDIOL SALICYLATE, CHLORPHENESIN, TROMETHAMINE, CERAMIDE 3, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, HEXYL CINNAMAL. MAY CONTAIN: TITANIUM DIOXIDE, RED 21 LAKE, RED 30 LAKE, IRON OXIDES, YELLOW 5 LAKE, RED 27 LAKE, RED 7 LAKE, TALC, BLUE 1 LAKE.

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

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Red/Red

cy°

HYDRAFULL
Labial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Red/Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Apple/Red

cy°

HYDRAFULL
Labial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Apple/Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rose/Red

cy°

HYDRAFULL
Labial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rose/Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Fucsia/Red

cy°

HYDRAFULL
Labial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Fucsia/Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Grape/Red

cy°

HYDRAFULL
Labial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Grape/Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Chocolate/Brown

cy°

HYDRAFULL
Labial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Chocolate/Brown

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Marsala/Red

cy°

HYDRAFULL
Labial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Marsala/Red

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rose Nude/Red

cy°

HYDRAFULL
Labial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

PRINCIPAL DISPLAY PANEL - 4 g Tube Box - Rose Nude/Red

CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 RED/RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0064
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0064-2	1 in 1 BOX	08/24/2017
1	NDC:43596-0064-1	4 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	08/24/2017

CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 APPLE/RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0065
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0065-2	1 in 1 BOX	08/24/2017
1	NDC:43596-0065-1	4 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	08/24/2017

CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 ROSE/RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0066
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0066-2	1 in 1 BOX	08/24/2017
1	NDC:43596-0066-1	4 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	08/24/2017

CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 FUCSIA/RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0067
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0067-2	1 in 1 BOX	08/24/2017
1	NDC:43596-0067-1	4 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	08/24/2017

CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 GRAPE/RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0068
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0068-2	1 in 1 BOX	08/24/2017
1	NDC:43596-0068-1	4 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	08/24/2017

CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 CHOCOLATE/BROWN
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0069
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0069-2	1 in 1 BOX	08/24/2017
1	NDC:43596-0069-1	4 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	08/24/2017

CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 MARSALA/RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0070
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0070-2	1 in 1 BOX	08/24/2017
1	NDC:43596-0070-1	4 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	08/24/2017

CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 ROSE NUDE/RED
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:43596-0071
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.075 g in 1 g

Ingredient Name	Strength
Inactive Ingredients
CASTOR OIL (UNII: D5340Y2I9G)
OCTYLDODECANOL (UNII: 461N1O614Y)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
SHEA BUTTER (UNII: K49155WL9Y)
CARNAUBA WAX (UNII: R12CBM0EIZ)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
GRAPE SEED OIL (UNII: 930MLC8XGG)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
SILANEDIOL SALICYLATE (UNII: C054DF30K0)
CHLORPHENESIN (UNII: I670DAL4SZ)
TROMETHAMINE (UNII: 023C2WHX2V)
CERAMIDE NP (UNII: 4370DF050B)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
.ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 21 (UNII: 08744Z6JNY)
ALUMINUM OXIDE (UNII: LMI26O6933)
D&C RED NO. 30 (UNII: 2S42T2808B)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 27 (UNII: 2LRS185U6K)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
TALC (UNII: 7SEV7J4R1U)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:43596-0071-2	1 in 1 BOX	08/24/2017
1	NDC:43596-0071-1	4 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	08/24/2017

Labeler - Ventura Corporation LTD (602751344)

Name	Address	ID/FEI	Business Operations
Establishment
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(43596-0064, 43596-0065, 43596-0066, 43596-0067, 43596-0068, 43596-0069, 43596-0070, 43596-0071)

Revised: 8/2017

Document Id: 3015f6cd-44c2-4f21-9418-3e34b8536c34

Set id: c5b9c45d-51b2-4b35-97d4-c19d2032a144

Version: 1

Effective Time: 20170824

Ventura Corporation LTD