NDC Code(s) : 10812-457-01, 10812-459-01, 10812-456-01, 10812-458-01
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Neutrogena Healthy Skin Brightening Eye Perfector Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-457
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP)
Titanium Dioxide18.8 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Cyclomethicone 5(UNII: 0THT5PCI0R)
Talc(UNII: 7SEV7J4R1U)
Butylene Glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
Ethylhexyl Palmitate(UNII: 2865993309)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Edetol(UNII: Q4R969U9FR)
Boron Nitride(UNII: 2U4T60A6YD)
Magnesium Sulfate, Unspecified Form(UNII: DE08037SAB)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Myristyl Alcohol(UNII: V42034O9PU)
Mica(UNII: V8A1AW0880)
1,2-Hexanediol(UNII: TR046Y3K1G)
Caprylyl Glycol(UNII: 00YIU5438U)
Coco-glycerides(UNII: ISE9I7DNUG)
Saccharomyces Lysate(UNII: R85W246Z1C)
aluminum starch octenylsuccinate(UNII: I9PJ0O6294)
DMDM Hydantoin(UNII: BYR0546TOW)
Propylparaben(UNII: Z8IX2SC1OH)
Aluminum oxide(UNII: LMI26O6933)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Glyceryl Laurate(UNII: Y98611C087)
stearyl alcohol(UNII: 2KR89I4H1Y)
Dimethicone(UNII: 92RU3N3Y1O)
soybean(UNII: L7HT8F1ZOD)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate)(UNII: 255PIF62MS)
Tocopherol(UNII: R0ZB2556P8)
Tanacetum Parthenium(UNII: 6GE7Z0761K)
Distearyl Ether(UNII: SC6T3MJF8Y)
Magnesium Carbonate(UNII: 0E53J927NA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-457-011 in 1 BLISTER PACK 24/05/2013
14.9 g in 1 APPLICATOR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 05/24/2013 12/01/2018
Neutrogena Healthy Skin Brightening Eye Perfector Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-459
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP)
Titanium Dioxide18.8 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Cyclomethicone 5(UNII: 0THT5PCI0R)
Talc(UNII: 7SEV7J4R1U)
Butylene Glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
Ethylhexyl Palmitate(UNII: 2865993309)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Edetol(UNII: Q4R969U9FR)
Boron Nitride(UNII: 2U4T60A6YD)
Magnesium Sulfate, Unspecified Form(UNII: DE08037SAB)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Myristyl Alcohol(UNII: V42034O9PU)
Mica(UNII: V8A1AW0880)
1,2-Hexanediol(UNII: TR046Y3K1G)
Caprylyl Glycol(UNII: 00YIU5438U)
Coco-glycerides(UNII: ISE9I7DNUG)
Saccharomyces Lysate(UNII: R85W246Z1C)
aluminum starch octenylsuccinate(UNII: I9PJ0O6294)
DMDM Hydantoin(UNII: BYR0546TOW)
Propylparaben(UNII: Z8IX2SC1OH)
Aluminum oxide(UNII: LMI26O6933)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Glyceryl Laurate(UNII: Y98611C087)
stearyl alcohol(UNII: 2KR89I4H1Y)
Dimethicone(UNII: 92RU3N3Y1O)
soybean(UNII: L7HT8F1ZOD)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate)(UNII: 255PIF62MS)
Tocopherol(UNII: R0ZB2556P8)
Tanacetum Parthenium(UNII: 6GE7Z0761K)
Distearyl Ether(UNII: SC6T3MJF8Y)
Magnesium Carbonate(UNII: 0E53J927NA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-459-011 in 1 BLISTER PACK 24/05/2013
14.9 g in 1 APPLICATOR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 05/24/2013 12/01/2018
Neutrogena Healthy Skin Brightening Eye Perfector Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-456
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP)
Titanium Dioxide18.8 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Cyclomethicone 5(UNII: 0THT5PCI0R)
Talc(UNII: 7SEV7J4R1U)
Butylene Glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
Ethylhexyl Palmitate(UNII: 2865993309)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Edetol(UNII: Q4R969U9FR)
Boron Nitride(UNII: 2U4T60A6YD)
Magnesium Sulfate, Unspecified Form(UNII: DE08037SAB)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Myristyl Alcohol(UNII: V42034O9PU)
Mica(UNII: V8A1AW0880)
1,2-Hexanediol(UNII: TR046Y3K1G)
Caprylyl Glycol(UNII: 00YIU5438U)
Coco-glycerides(UNII: ISE9I7DNUG)
Saccharomyces Lysate(UNII: R85W246Z1C)
aluminum starch octenylsuccinate(UNII: I9PJ0O6294)
DMDM Hydantoin(UNII: BYR0546TOW)
Propylparaben(UNII: Z8IX2SC1OH)
Aluminum oxide(UNII: LMI26O6933)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Glyceryl Laurate(UNII: Y98611C087)
stearyl alcohol(UNII: 2KR89I4H1Y)
Dimethicone(UNII: 92RU3N3Y1O)
soybean(UNII: L7HT8F1ZOD)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate)(UNII: 255PIF62MS)
Tocopherol(UNII: R0ZB2556P8)
Tanacetum Parthenium(UNII: 6GE7Z0761K)
Distearyl Ether(UNII: SC6T3MJF8Y)
Magnesium Carbonate(UNII: 0E53J927NA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-456-011 in 1 BLISTER PACK 24/05/2013
14.9 g in 1 APPLICATOR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 05/24/2013 12/01/2018
Neutrogena Healthy Skin Brightening Eye Perfector Titanium Dioxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-458
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Titanium Dioxide(UNII: 15FIX9V2JP)
(Titanium Dioxide - UNII:15FIX9V2JP)
Titanium Dioxide18.8 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Cyclomethicone 5(UNII: 0THT5PCI0R)
Talc(UNII: 7SEV7J4R1U)
Butylene Glycol(UNII: 3XUS85K0RA)
cyclomethicone 6(UNII: XHK3U310BA)
Ethylhexyl Palmitate(UNII: 2865993309)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Edetol(UNII: Q4R969U9FR)
Boron Nitride(UNII: 2U4T60A6YD)
Magnesium Sulfate, Unspecified Form(UNII: DE08037SAB)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Myristyl Alcohol(UNII: V42034O9PU)
Mica(UNII: V8A1AW0880)
1,2-Hexanediol(UNII: TR046Y3K1G)
Caprylyl Glycol(UNII: 00YIU5438U)
Coco-glycerides(UNII: ISE9I7DNUG)
Saccharomyces Lysate(UNII: R85W246Z1C)
aluminum starch octenylsuccinate(UNII: I9PJ0O6294)
DMDM Hydantoin(UNII: BYR0546TOW)
Propylparaben(UNII: Z8IX2SC1OH)
Aluminum oxide(UNII: LMI26O6933)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Glyceryl Laurate(UNII: Y98611C087)
stearyl alcohol(UNII: 2KR89I4H1Y)
Dimethicone(UNII: 92RU3N3Y1O)
soybean(UNII: L7HT8F1ZOD)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate)(UNII: 255PIF62MS)
Tocopherol(UNII: R0ZB2556P8)
Tanacetum Parthenium(UNII: 6GE7Z0761K)
Distearyl Ether(UNII: SC6T3MJF8Y)
Magnesium Carbonate(UNII: 0E53J927NA)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-458-011 in 1 BLISTER PACK 24/05/2013
14.9 g in 1 APPLICATOR Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 05/24/2013 12/01/2018

PRINCIPAL DISPLAY PANEL

LIGHT 10

healthy skin
brightening eye perfector

with
titanium-
dioxide-
sunscreen
broad
spectrum
SPF 25

Neutrogena®

Instantly
brightens

Conceals
circles

Evens tone

NET WT. 0.17 OZ. (4.9g)

PRINCIPAL DISPLAY PANEL - 4.9g Applicator Blister Pack - LIGHT 10

PRINCIPAL DISPLAY PANEL

BUFF 09

healthy skin
brightening eye perfector

with
titanium-
dioxide-
sunscreen
broad
spectrum
SPF 25

Neutrogena®

Instantly
brightens

Conceals
circles

Evens tone

NET WT. 0.17 OZ. (4.9g)

PRINCIPAL DISPLAY PANEL - 4.9g Applicator Blister Pack - BUFF 09

PRINCIPAL DISPLAY PANEL

FAIR 05

healthy skin
brightening eye perfector

with
titanium-
dioxide-
sunscreen
broad
spectrum
SPF 25

Neutrogena®

Instantly
brightens

Conceals
circles

Evens tone

NET WT. 0.17 OZ. (4.9g)

PRINCIPAL DISPLAY PANEL - 4.9g Applicator Blister Pack - FAIR 05

PRINCIPAL DISPLAY PANEL

MEDIUM 15

healthy skin
brightening eye perfector

with
titanium-
dioxide-
sunscreen
broad
spectrum
SPF 25

Neutrogena®

Instantly
brightens

Conceals
circles

Evens tone

NET WT. 0.17 OZ. (4.9g)

PRINCIPAL DISPLAY PANEL - 4.9g Applicator Blister Pack - MEDIUM 15