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 -

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
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NDC	43596-0064-1, 43596-0064-2, 43596-0065-1, 43596-0065-2, 43596-0066-1, 43596-0066-2, 43596-0067-1, 43596-0067-2, 43596-0068-1, 43596-0068-2, 43596-0069-1, 43596-0069-2, 43596-0070-1, 43596-0070-2, 43596-0071-1, 43596-0071-2
Set ID	c5b9c45d-51b2-4b35-97d4-c19d2032a144
Category	HUMAN OTC DRUG LABEL
Packager	Ventura Corporation LTD
Generic Name
Product Class
Product Number
Application Number	PART352

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SPL UNCLASSIFIED SECTION

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.
SPL UNCLASSIFIED SECTION

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 - 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 - 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 - 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 - 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 - 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 - 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 - Rose Nude/Red

cy°

HYDRAFULL
Labial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

INGREDIENTS AND APPEARANCE

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
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
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
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
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
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
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
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
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)

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Medic

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

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