DailyMed - 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)

Contains inactivated NDC Code(s)
NDC Code(s): 14783-810-01, 14783-810-02, 14783-811-01, 14783-811-02, view more
14783-812-01, 14783-812-02, 14783-813-01, 14783-813-02, 14783-814-01, 14783-814-02, 14783-815-01, 14783-815-02, 14783-816-01, 14783-816-02, 14783-817-01, 14783-817-02, 14783-818-01, 14783-818-02, 14783-819-01, 14783-819-02, 14783-820-01, 14783-820-02, 14783-821-01, 14783-821-02
Packager: Ventura International LTD

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None
Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 28, 2017

If you are a consumer or patient please visit this version.

Download DRUG LABEL INFO: PDF XML
Official Label (Printer Friendly)

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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

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PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)
PRINCIPAL DISPLAY PANEL - 30 ml Tube Box - (BEIGE 2) - BROWN

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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

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PRO

Hydro-Nutritive
Foundation SPF 15

30 ml e (1 fl.oz.)

Active Ingredients	Purpose
Octinoxate 5.00 %	Sunscreen
Oxybenzone 2.00 %	Sunscreen

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part352	08/24/2015

Labeler - Ventura International LTD (603192787)

Name	Address	ID/FEI	Business Operations
Establishment
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)

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Published Date (What is this?)	Version	Files
Nov 29, 2017	2 (current)	download
Aug 28, 2015	1	download

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	NDC
1	14783-810-01
2	14783-810-02 (inactivated)
3	14783-811-01
4	14783-811-02 (inactivated)
5	14783-812-01
6	14783-812-02 (inactivated)
7	14783-813-01
8	14783-813-02 (inactivated)
9	14783-814-01
10	14783-814-02 (inactivated)
11	14783-815-01
12	14783-815-02 (inactivated)
13	14783-816-01
14	14783-816-02 (inactivated)
15	14783-817-01
16	14783-817-02 (inactivated)
17	14783-818-01
18	14783-818-02 (inactivated)
19	14783-819-01
20	14783-819-02 (inactivated)
21	14783-820-01
22	14783-820-02 (inactivated)
23	14783-821-01
24	14783-821-02 (inactivated)

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