ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (FUCSIA) - PINK- octinoxate lipstick 
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (CEREZA) - PINK- octinoxate lipstick 
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (ROSA) - PINK- octinoxate lipstick 
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (RUBI) - PINK- octinoxate lipstick 
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (AMBAR) - YELLOW- octinoxate lipstick 
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (FRESA) - PINK- octinoxate lipstick 
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (CHAMPAGNE) - BEIGE- octinoxate lipstick 
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (COBRE) - ORANGE- octinoxate lipstick 
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (PIMIENTA CALIENTE) - PINK- octinoxate lipstick 
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (DIAMANTE ROSA) - PINK- octinoxate lipstick 
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (MELON) - ORANGE- octinoxate lipstick 
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 (VINO) - BEIGE- octinoxate lipstick 
Ventura International LTD

----------

ESIKA PRO MULTI-GLOSS LIPSTICK DUAL LIPSTICK WITH TRIPLE GLOSS EFFECT SPF 15

Drug Facts

Active Ingredients

Octinoxate 7.00%

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, notskin cancer or early skin aging.
  • For external use only.

  • Do not useon damaged or broken skin.

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

  • Stop use and ask a doctor ifrash 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

LIPSTICK

DIISOPROPYL DIMER DILINOLEATE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, OCTYLDODECANOL, CAPRYLIC/CAPRIC TRIGLYCERIDE, ETHYLHEXYL PALMITATE, TRIDECYL TRIMELLITATE, EUPHORBIA CERIFERA (CANDELILLA) WAX, SYNTHETIC BEESWAX, POLYETHYLENE, COPERNICIA CERIFERA (CARNAUBA) WAX, BUTYROSPERMUM PARKII (SHEA) BUTTER, TRIDECYL STEARATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, SILICA SILYLATE, PHENOXYETHANOL, GLYCERYL ISOSTEARATE, ISOSTEARYL ALCOHOL, BETA-SITOSTEROL, CAPRYLYL GLYCOL, TOCOPHERYL ACETATE, CHLORPHENESIN, DIMETHICONE, FRAGRANCE, CERAMIDE 3, PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE, TRIMETHYLSILOXYSILICATE.

GLOSS

OCTYLDODECANOL, TRIDECYL TRIMELLITATE, POLYETHYLENE, OZOKERITE, PARAFFIN, COPERNICIA CERIFERA (CARNAUBA) WAX, PHENOXYETHANOL, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TOCOPHERYL ACETATE, DIMETHICONE, FRAGRANCE, CAPRYLYL GLYCOL, CERAMIDE 3, CHLORPHENESIN, TRIDECYL STEARATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, TRIMETHYLSILOXYSILICATE.

MAY CONTAIN:

SYNTHETIC FLUORPHLOGOPITE, RED 21 LAKE, MICA, IRON OXIDES, CALCIUM SODIUM BOROSILICATE, YELLOW 5 LAKE, TITANIUM DIOXIDE, RED 27 LAKE, RED 7 LAKE, TALC, SILICA, RED 30 LAKE, PEG-8 METHYL ETHER TRIETHOXYSILANE, TIN OXIDE, BLUE 1 LAKE.

Dist. by Ventura
Int Ltd. DBA Belcorp USA,
Miami, FL 33126.

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (FUCSIA) - PINK

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (FUCSIA) - PINK

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (CEREZA) - PINK

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (CEREZA) - PINK

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (ROSA) - PINK

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (ROSA) - PINK

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (RUBI) - PINK

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (RUBI) - PINK

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (AMBAR) - YELLOW

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (AMBAR) - YELLOW

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (FRESA) - PINK

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (FRESA) - PINK

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (CHAMPAGNE) - BEIGE

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (CHAMPAGNE) - BEIGE

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (COBRE) - ORANGE

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (COBRE) - ORANGE

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (PIMIENTA CALIENTE) - PINK

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (PIMIENTA CALIENTE) - PINK

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (DIAMANTE ROSA) - PINK

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (DIAMANTE ROSA) - PINK

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (MELON) - ORANGE

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (MELON) - ORANGE

PRINCIPAL DISPLAY PANEL - 3,8 g Tube Box - (VINO) - BEIGE

ésika
PRO

Dual Lipstickwith
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e(3,8 g)

Principal Display Panel - 3,8 g Tube Box - (VINO) - BEIGE
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (FUCSIA) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-833
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-833-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-833-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (CEREZA) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-834
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-834-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-834-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (ROSA) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-835
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-835-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-835-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (RUBI) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-836
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-836-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-836-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (AMBAR) - YELLOW
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-837
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-837-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-837-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (FRESA) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-838
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-838-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-838-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (CHAMPAGNE) - BEIGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-839
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-839-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-839-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (COBRE) - ORANGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-840
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-840-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-840-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (PIMIENTA CALIENTE) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-841
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-841-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-841-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (DIAMANTE ROSA) - PINK
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-842
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-842-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-842-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (MELON) - ORANGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-843
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-843-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-843-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15  (VINO) - BEIGE
octinoxate lipstick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14783-844
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.07 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
DIISOPROPYL DILINOLEATE (UNII: 5323S7S2LR)  
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE (UNII: 554N82UWVW)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
CANDELILLA WAX (UNII: WL0328HX19)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SHEA BUTTER (UNII: K49155WL9Y)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERYL ISOSTEARATE (UNII: HYE7O27HAO)  
ISOSTEARYL ALCOHOL (UNII: Q613OCQ44Y)  
.BETA.-SITOSTEROL (UNII: S347WMO6M4)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CERAMIDE 3 (UNII: 4370DF050B)  
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
PARAFFIN (UNII: I9O0E3H2ZE)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
MICA (UNII: V8A1AW0880)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
D&C RED NO. 7 (UNII: ECW0LZ41X8)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
D&C RED NO. 30 (UNII: 2S42T2808B)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:14783-844-021 in 1 BOX08/31/201512/31/2021
1NDC:14783-844-013.8 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02008/31/201512/31/2021
Labeler - Ventura International LTD (603192787)
Establishment
NameAddressID/FEIBusiness Operations
Bel Star S.A. (Colombia)880160197manufacture(14783-833, 14783-834, 14783-835, 14783-836, 14783-837, 14783-838, 14783-839, 14783-840, 14783-841, 14783-842, 14783-843, 14783-844)

Revised: 3/2025
Document Id: 31047ddd-470c-b26c-e063-6294a90adff9
Set id: 6e52e730-9ede-4329-8aaf-1121d1ca7431
Version: 3
Effective Time: 20250323
 
Ventura International LTD