PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (BEIGE 1) - BROWN- octinoxate and oxybenzone lotion PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (BEIGE 2) - BROWN- octinoxate and oxybenzone lotion PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (BEIGE 3) - BROWN (octi .......FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (ROSA 4) - PINK- octinoxate and oxybenzone lotion PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (ROSA 5) - PINK- octinoxate and oxybenzone lotion PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 (ROSA 6) - PINK- octinoxate and oxybenzone lotion

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15 by

Drug Labeling and Warnings

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 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 INGREDIENT

Active Ingredients	Purpose
Octinoxate 5.00 %	Sunscreen
Oxybenzone 2.00 %	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

WATER, CYCLOMETHICONE, CYCLOPENTASILOXANE, TALC, CETYL PEG/PPG-10/1 DIMETHICONE, POLYGLYCERYL-4 ISOSTEARATE, PISUM SATIVUM (PEA) EXTRACT, PEG-12 DIMETHICONE CROSSPOLYMER, HEXYL LAURATE, ISOSTEARYL NEOPENTANOATE, DISTEARDIMONIUM HECTORITE, CYCLOHEXASILOXANE, HYDROXYACETOPHENONE, ROSA CENTIFOLIA FLOWER WATER, SODIUM CHLORIDE, PHENOXYETHANOL, MANNITOL, DIMETHICONE, PROPYLENE CARBONATE, PROPYLENE GLYCOL, OCTYLDODECANOL, BUTYLENE GLYCOL, DIMETHICONOL, CAPRYLYL GLYCOL, CETEARYL DIMETHICONE CROSSPOLYMER, TOCOPHERYL ACETATE, CHLORPHENESIN, MICROCRYSTALLINE WAX, POLYMETHYLSILSESQUIOXANE, PETROLATUM, PHOSPHOLIPIDS, CYCLODEXTRIN, CHOLESTEROL, YEAST EXTRACT, EUPHORBIA CERIFERA (CANDELILLA) WAX, BEESWAX, CETEARYL ALCOHOL, CETEARYL GLUCOSIDE, COPERNICIA CERIFERA (CARNAUBA ) WAX, POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE, GLYCOSPHINGOLIPIDS, DISODIUM SUCCINATE. MAY CONTAIN: TITANIUM DIOXIDE, METHICONE, IRON OXIDES.

SPL UNCLASSIFIED SECTION

U.S.A.: Dist. by Ventura Int Ltd. DBA Belcorp
USA, Miami, FL 33126.

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 1) - BROWN

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 2) - BROWN

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 3) - BROWN

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 4) - BROWN

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 5) - BROWN

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 6) - BROWN

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 1) - PINK

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 2) - PINK

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 3) - PINK

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 4) - PINK

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 5) - PINK

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (ROSA 6) - PINK

ésika
PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

INGREDIENTS AND APPEARANCE

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (BEIGE 1) - BROWN
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-817
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-817-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-817-01	30 mL 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	08/24/2015

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (BEIGE 2) - BROWN
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-818
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-818-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-818-01	30 mL 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	08/24/2015

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (BEIGE 3) - BROWN
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-819
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-819-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-819-01	30 mL 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	08/24/2015

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (BEIGE 4) - BROWN
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-820
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-820-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-820-01	30 mL 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	08/24/2015

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (BEIGE 5) - BROWN
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-821
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-821-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-821-01	30 mL 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	08/24/2015

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (BEIGE 6) - BROWN
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-810
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-810-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-810-01	30 mL 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	08/24/2015

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (ROSA 1) - PINK
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-811
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-811-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-811-01	30 mL 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	08/24/2015

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (ROSA 2) - PINK
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-812
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-812-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-812-01	30 mL 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	08/24/2015

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (ROSA 3) - PINK
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-813
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-813-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-813-01	30 mL 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	08/24/2015

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (ROSA 4) - PINK
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-814
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-814-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-814-01	30 mL 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	08/24/2015

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (ROSA 5) - PINK
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-815
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-815-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-815-01	30 mL 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	08/24/2015

PRO HYDRO-NUTRITIVE FOUNDATION SPF 15/ BASE DE MAQUILLAJE HIDRO - NUTRITIVA FPS 15   (ROSA 6) - PINK
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 14783-816
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.05 g  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE (UNII: NMQ347994Z)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
TALC (UNII: 7SEV7J4R1U)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
PEA (UNII: W4X7H8GYFM)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
ISOSTEARYL NEOPENTANOATE (UNII: 411THY156Q)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
ROSA CENTIFOLIA FLOWER OIL (UNII: H32V31VMWY)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
MANNITOL (UNII: 3OWL53L36A)
DIMETHICONE (UNII: 92RU3N3Y1O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
PETROLATUM (UNII: 4T6H12BN9U)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CHOLESTEROL (UNII: 97C5T2UQ7J)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
SODIUM SUCCINATE ANHYDROUS (UNII: V8ZGC8ISR3)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 14783-816-02	1 in 1 BOX	08/24/2015
1	NDC: 14783-816-01	30 mL 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	08/24/2015

Labeler - Ventura International LTD (603192787)

Establishment
Name	Address	ID/FEI	Business Operations
Bel Star S.A. (Colombia)		880160197	MANUFACTURE(14783-817, 14783-818, 14783-819, 14783-820, 14783-821, 14783-810, 14783-811, 14783-812, 14783-813, 14783-814, 14783-815, 14783-816)