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

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

Drug Labeling and Warnings

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15 by is a Otc medication manufactured, distributed, or labeled by Ventura International LTD, Bel Star S.A. (Colombia). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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, 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

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.

SPL UNCLASSIFIED SECTION

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

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

ésika
PRO

Dual Lipstick with
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e (3,8 g)

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

ésika
PRO

Dual Lipstick with
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e (3,8 g)

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

ésika
PRO

Dual Lipstick with
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e (3,8 g)

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

ésika
PRO

Dual Lipstick with
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e (3,8 g)

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

ésika
PRO

Dual Lipstick with
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e (3,8 g)

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

ésika
PRO

Dual Lipstick with
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e (3,8 g)

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

ésika
PRO

Dual Lipstick with
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e (3,8 g)

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

ésika
PRO

Dual Lipstick with
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

ésika
PRO

Dual Lipstick with
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

ésika
PRO

Dual Lipstick with
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e (3,8 g)

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

ésika
PRO

Dual Lipstick with
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e (3,8 g)

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

ésika
PRO

Dual Lipstick with
Triple Gloss Effect
SPF 15

Net Weight

0.13 oz. e (3,8 g)

INGREDIENTS AND APPEARANCE

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (FUCSIA) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-833
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-833-02	1 in 1 BOX
1	NDC: 14783-833-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (CEREZA) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-834
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-834-02	1 in 1 BOX
1	NDC: 14783-834-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (ROSA) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-835
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-835-02	1 in 1 BOX
1	NDC: 14783-835-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (RUBI) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-836
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-836-02	1 in 1 BOX
1	NDC: 14783-836-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (AMBAR) - YELLOW
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-837
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-837-02	1 in 1 BOX
1	NDC: 14783-837-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (FRESA) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-838
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-838-02	1 in 1 BOX
1	NDC: 14783-838-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (CHAMPAGNE) - BEIGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-839
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-839-02	1 in 1 BOX
1	NDC: 14783-839-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (COBRE) - ORANGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-840
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-840-02	1 in 1 BOX
1	NDC: 14783-840-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (PIMIENTA CALIENTE) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-841
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-841-02	1 in 1 BOX
1	NDC: 14783-841-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (DIAMANTE ROSA) - PINK
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-842
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-842-02	1 in 1 BOX
1	NDC: 14783-842-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (MELON) - ORANGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-843
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-843-02	1 in 1 BOX
1	NDC: 14783-843-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

ESIKA PRO MULTI-GLOSS DUAL WITH TRIPLE GLOSS EFFECT SPF 15   (VINO) - BEIGE
octinoxate lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-844
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-844-02	1 in 1 BOX
1	NDC: 14783-844-01	3.8 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	08/31/2015

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-833, 14783-834, 14783-835, 14783-836, 14783-837, 14783-838, 14783-839, 14783-840, 14783-841, 14783-842, 14783-843, 14783-844)