CY HYDRAFULL LABIAL HIDRATANTE FULL COLOR FPS 15 Red/Red: Package Insert and Label Information

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.

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 — Apple/Red

cy°

HYDRAFULLLabial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

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

cy°

HYDRAFULLLabial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

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

cy°

HYDRAFULLLabial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

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

cy°

HYDRAFULLLabial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

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

cy°

HYDRAFULLLabial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

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

cy°

HYDRAFULLLabial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

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

cy°

HYDRAFULLLabial hidratante full color FPS 15

Net Wt. 0.14 oz. e (4 g)

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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (Octinoxate) Octinoxate 0.075 g in 1 g

Inactive Ingredients Ingredient Name Strength CASTOR OIL OCTYLDODECANOL HIGH DENSITY POLYETHYLENE SHEA BUTTER CARNAUBA WAX DISTEARDIMONIUM HECTORITE GRAPE SEED OIL PROPYLENE CARBONATE SILICA DIMETHYL SILYLATE .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL METHYLPROPANEDIOL CAPRYLYL GLYCOL SILANEDIOL SALICYLATE CHLORPHENESIN TROMETHAMINE CERAMIDE NP PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) .ALPHA.-HEXYLCINNAMALDEHYDE TITANIUM DIOXIDE D&C RED NO. 21 ALUMINUM OXIDE D&C RED NO. 30 FERRIC OXIDE RED FD&C YELLOW NO. 5 D&C RED NO. 27 D&C RED NO. 7 TALC FD&C BLUE NO. 1

Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43596-0064-2 1 TUBE in 1 BOX contains a TUBE (43596-0064-1) 1 NDC:43596-0064-1 4 g in 1 TUBE This package is contained within the BOX (43596-0064-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (Octinoxate) Octinoxate 0.075 g in 1 g

Inactive Ingredients Ingredient Name Strength CASTOR OIL OCTYLDODECANOL HIGH DENSITY POLYETHYLENE SHEA BUTTER CARNAUBA WAX DISTEARDIMONIUM HECTORITE GRAPE SEED OIL PROPYLENE CARBONATE SILICA DIMETHYL SILYLATE .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL METHYLPROPANEDIOL CAPRYLYL GLYCOL SILANEDIOL SALICYLATE CHLORPHENESIN TROMETHAMINE CERAMIDE NP PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) .ALPHA.-HEXYLCINNAMALDEHYDE TITANIUM DIOXIDE D&C RED NO. 21 ALUMINUM OXIDE D&C RED NO. 30 FERRIC OXIDE RED FD&C YELLOW NO. 5 D&C RED NO. 27 D&C RED NO. 7 TALC FD&C BLUE NO. 1

Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43596-0065-2 1 TUBE in 1 BOX contains a TUBE (43596-0065-1) 1 NDC:43596-0065-1 4 g in 1 TUBE This package is contained within the BOX (43596-0065-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (Octinoxate) Octinoxate 0.075 g in 1 g

Inactive Ingredients Ingredient Name Strength CASTOR OIL OCTYLDODECANOL HIGH DENSITY POLYETHYLENE SHEA BUTTER CARNAUBA WAX DISTEARDIMONIUM HECTORITE GRAPE SEED OIL PROPYLENE CARBONATE SILICA DIMETHYL SILYLATE .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL METHYLPROPANEDIOL CAPRYLYL GLYCOL SILANEDIOL SALICYLATE CHLORPHENESIN TROMETHAMINE CERAMIDE NP PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) .ALPHA.-HEXYLCINNAMALDEHYDE TITANIUM DIOXIDE D&C RED NO. 21 ALUMINUM OXIDE D&C RED NO. 30 FERRIC OXIDE RED FD&C YELLOW NO. 5 D&C RED NO. 27 D&C RED NO. 7 TALC FD&C BLUE NO. 1

Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43596-0066-2 1 TUBE in 1 BOX contains a TUBE (43596-0066-1) 1 NDC:43596-0066-1 4 g in 1 TUBE This package is contained within the BOX (43596-0066-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (Octinoxate) Octinoxate 0.075 g in 1 g

Inactive Ingredients Ingredient Name Strength CASTOR OIL OCTYLDODECANOL HIGH DENSITY POLYETHYLENE SHEA BUTTER CARNAUBA WAX DISTEARDIMONIUM HECTORITE GRAPE SEED OIL PROPYLENE CARBONATE SILICA DIMETHYL SILYLATE .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL METHYLPROPANEDIOL CAPRYLYL GLYCOL SILANEDIOL SALICYLATE CHLORPHENESIN TROMETHAMINE CERAMIDE NP PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) .ALPHA.-HEXYLCINNAMALDEHYDE TITANIUM DIOXIDE D&C RED NO. 21 ALUMINUM OXIDE D&C RED NO. 30 FERRIC OXIDE RED FD&C YELLOW NO. 5 D&C RED NO. 27 D&C RED NO. 7 TALC FD&C BLUE NO. 1

Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43596-0067-2 1 TUBE in 1 BOX contains a TUBE (43596-0067-1) 1 NDC:43596-0067-1 4 g in 1 TUBE This package is contained within the BOX (43596-0067-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (Octinoxate) Octinoxate 0.075 g in 1 g

Inactive Ingredients Ingredient Name Strength CASTOR OIL OCTYLDODECANOL HIGH DENSITY POLYETHYLENE SHEA BUTTER CARNAUBA WAX DISTEARDIMONIUM HECTORITE GRAPE SEED OIL PROPYLENE CARBONATE SILICA DIMETHYL SILYLATE .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL METHYLPROPANEDIOL CAPRYLYL GLYCOL SILANEDIOL SALICYLATE CHLORPHENESIN TROMETHAMINE CERAMIDE NP PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) .ALPHA.-HEXYLCINNAMALDEHYDE TITANIUM DIOXIDE D&C RED NO. 21 ALUMINUM OXIDE D&C RED NO. 30 FERRIC OXIDE RED FD&C YELLOW NO. 5 D&C RED NO. 27 D&C RED NO. 7 TALC FD&C BLUE NO. 1

Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43596-0068-2 1 TUBE in 1 BOX contains a TUBE (43596-0068-1) 1 NDC:43596-0068-1 4 g in 1 TUBE This package is contained within the BOX (43596-0068-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (Octinoxate) Octinoxate 0.075 g in 1 g

Inactive Ingredients Ingredient Name Strength CASTOR OIL OCTYLDODECANOL HIGH DENSITY POLYETHYLENE SHEA BUTTER CARNAUBA WAX DISTEARDIMONIUM HECTORITE GRAPE SEED OIL PROPYLENE CARBONATE SILICA DIMETHYL SILYLATE .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL METHYLPROPANEDIOL CAPRYLYL GLYCOL SILANEDIOL SALICYLATE CHLORPHENESIN TROMETHAMINE CERAMIDE NP PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) .ALPHA.-HEXYLCINNAMALDEHYDE TITANIUM DIOXIDE D&C RED NO. 21 ALUMINUM OXIDE D&C RED NO. 30 FERRIC OXIDE RED FD&C YELLOW NO. 5 D&C RED NO. 27 D&C RED NO. 7 TALC FD&C BLUE NO. 1

Product Characteristics Color BROWN Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43596-0069-2 1 TUBE in 1 BOX contains a TUBE (43596-0069-1) 1 NDC:43596-0069-1 4 g in 1 TUBE This package is contained within the BOX (43596-0069-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (Octinoxate) Octinoxate 0.075 g in 1 g

Inactive Ingredients Ingredient Name Strength CASTOR OIL OCTYLDODECANOL HIGH DENSITY POLYETHYLENE SHEA BUTTER CARNAUBA WAX DISTEARDIMONIUM HECTORITE GRAPE SEED OIL PROPYLENE CARBONATE SILICA DIMETHYL SILYLATE .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL METHYLPROPANEDIOL CAPRYLYL GLYCOL SILANEDIOL SALICYLATE CHLORPHENESIN TROMETHAMINE CERAMIDE NP PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) .ALPHA.-HEXYLCINNAMALDEHYDE TITANIUM DIOXIDE D&C RED NO. 21 ALUMINUM OXIDE D&C RED NO. 30 FERRIC OXIDE RED FD&C YELLOW NO. 5 D&C RED NO. 27 D&C RED NO. 7 TALC FD&C BLUE NO. 1

Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43596-0070-2 1 TUBE in 1 BOX contains a TUBE (43596-0070-1) 1 NDC:43596-0070-1 4 g in 1 TUBE This package is contained within the BOX (43596-0070-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date 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 DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Octinoxate (Octinoxate) Octinoxate 0.075 g in 1 g

Inactive Ingredients Ingredient Name Strength CASTOR OIL OCTYLDODECANOL HIGH DENSITY POLYETHYLENE SHEA BUTTER CARNAUBA WAX DISTEARDIMONIUM HECTORITE GRAPE SEED OIL PROPYLENE CARBONATE SILICA DIMETHYL SILYLATE .ALPHA.-TOCOPHEROL ACETATE PHENOXYETHANOL METHYLPROPANEDIOL CAPRYLYL GLYCOL SILANEDIOL SALICYLATE CHLORPHENESIN TROMETHAMINE CERAMIDE NP PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) .ALPHA.-HEXYLCINNAMALDEHYDE TITANIUM DIOXIDE D&C RED NO. 21 ALUMINUM OXIDE D&C RED NO. 30 FERRIC OXIDE RED FD&C YELLOW NO. 5 D&C RED NO. 27 D&C RED NO. 7 TALC FD&C BLUE NO. 1

Product Characteristics Color RED Score Shape Size Flavor Imprint Code Contains

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43596-0071-2 1 TUBE in 1 BOX contains a TUBE (43596-0071-1) 1 NDC:43596-0071-1 4 g in 1 TUBE This package is contained within the BOX (43596-0071-2)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part352 08/24/2017

Labeler — Ventura Corporation LTD (602751344)

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

Revised: 08/2017 Ventura Corporation LTD