NDC Code(s) : 10812-091-01, 10812-092-01, 10812-093-01, 10812-094-01, 10812-095-01, 10812-096-01, 10812-097-01, 10812-098-01
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Neutrogena Healthy Skin Compact Makeup Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-091
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone28 mg in 1 g
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate80 mg in 1 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 g
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene90 mg in 1 g
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Isononyl Isononanoate(UNII: S4V5BS6GCX)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Yellow Wax(UNII: 2ZA36H0S2V)
Mica(UNII: V8A1AW0880)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Diethylhexyl 2,6-Naphthalate(UNII: I0DQJ7YGXM)
Dimethicone(UNII: 92RU3N3Y1O)
Phenoxyethanol(UNII: HIE492ZZ3T)
Caprylyl Glycol(UNII: 00YIU5438U)
Levomenol(UNII: 24WE03BX2T)
Pantothenic Acid(UNII: 19F5HK2737)
Vitamin A Palmitate(UNII: 1D1K0N0VVC)
Ascorbic Acid(UNII: PQ6CK8PD0R)
Titanium Dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-091-019.9 g in 1 CONTAINER Type 0: Not a Combination Product12/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 12/06/2010 09/01/2018
Neutrogena Healthy Skin Compact Makeup Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-092
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone28 mg in 1 g
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate80 mg in 1 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 g
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene90 mg in 1 g
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Isononyl Isononanoate(UNII: S4V5BS6GCX)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Yellow Wax(UNII: 2ZA36H0S2V)
Mica(UNII: V8A1AW0880)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Diethylhexyl 2,6-Naphthalate(UNII: I0DQJ7YGXM)
Dimethicone(UNII: 92RU3N3Y1O)
Phenoxyethanol(UNII: HIE492ZZ3T)
Caprylyl Glycol(UNII: 00YIU5438U)
Levomenol(UNII: 24WE03BX2T)
Pantothenic Acid(UNII: 19F5HK2737)
Vitamin A Palmitate(UNII: 1D1K0N0VVC)
Ascorbic Acid(UNII: PQ6CK8PD0R)
Titanium Dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-092-019.9 g in 1 CONTAINER Type 0: Not a Combination Product12/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 12/06/2010 09/01/2018
Neutrogena Healthy Skin Compact Makeup Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-093
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone28 mg in 1 g
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate80 mg in 1 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 g
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene90 mg in 1 g
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Isononyl Isononanoate(UNII: S4V5BS6GCX)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Yellow Wax(UNII: 2ZA36H0S2V)
Mica(UNII: V8A1AW0880)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Diethylhexyl 2,6-Naphthalate(UNII: I0DQJ7YGXM)
Dimethicone(UNII: 92RU3N3Y1O)
Phenoxyethanol(UNII: HIE492ZZ3T)
Caprylyl Glycol(UNII: 00YIU5438U)
Levomenol(UNII: 24WE03BX2T)
Pantothenic Acid(UNII: 19F5HK2737)
Vitamin A Palmitate(UNII: 1D1K0N0VVC)
Ascorbic Acid(UNII: PQ6CK8PD0R)
Titanium Dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-093-019.9 g in 1 CONTAINER Type 0: Not a Combination Product12/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 12/06/2010 09/01/2018
Neutrogena Healthy Skin Compact Makeup Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-094
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone28 mg in 1 g
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate80 mg in 1 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 g
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene90 mg in 1 g
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Isononyl Isononanoate(UNII: S4V5BS6GCX)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Yellow Wax(UNII: 2ZA36H0S2V)
Mica(UNII: V8A1AW0880)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Diethylhexyl 2,6-Naphthalate(UNII: I0DQJ7YGXM)
Dimethicone(UNII: 92RU3N3Y1O)
Phenoxyethanol(UNII: HIE492ZZ3T)
Caprylyl Glycol(UNII: 00YIU5438U)
Levomenol(UNII: 24WE03BX2T)
Pantothenic Acid(UNII: 19F5HK2737)
Vitamin A Palmitate(UNII: 1D1K0N0VVC)
Ascorbic Acid(UNII: PQ6CK8PD0R)
Titanium Dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-094-019.9 g in 1 CONTAINER Type 0: Not a Combination Product12/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 12/06/2010 09/01/2018
Neutrogena Healthy Skin Compact Makeup Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-095
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone28 mg in 1 g
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate80 mg in 1 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 g
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene90 mg in 1 g
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Isononyl Isononanoate(UNII: S4V5BS6GCX)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Yellow Wax(UNII: 2ZA36H0S2V)
Mica(UNII: V8A1AW0880)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Diethylhexyl 2,6-Naphthalate(UNII: I0DQJ7YGXM)
Dimethicone(UNII: 92RU3N3Y1O)
Phenoxyethanol(UNII: HIE492ZZ3T)
Caprylyl Glycol(UNII: 00YIU5438U)
Levomenol(UNII: 24WE03BX2T)
Pantothenic Acid(UNII: 19F5HK2737)
Vitamin A Palmitate(UNII: 1D1K0N0VVC)
Ascorbic Acid(UNII: PQ6CK8PD0R)
Titanium Dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-095-019.9 g in 1 CONTAINER Type 0: Not a Combination Product12/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 12/06/2010 09/01/2018
Neutrogena Healthy Skin Compact Makeup Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-096
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone28 mg in 1 g
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate80 mg in 1 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 g
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene90 mg in 1 g
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Isononyl Isononanoate(UNII: S4V5BS6GCX)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Yellow Wax(UNII: 2ZA36H0S2V)
Mica(UNII: V8A1AW0880)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Diethylhexyl 2,6-Naphthalate(UNII: I0DQJ7YGXM)
Dimethicone(UNII: 92RU3N3Y1O)
Phenoxyethanol(UNII: HIE492ZZ3T)
Caprylyl Glycol(UNII: 00YIU5438U)
Levomenol(UNII: 24WE03BX2T)
Pantothenic Acid(UNII: 19F5HK2737)
Vitamin A Palmitate(UNII: 1D1K0N0VVC)
Ascorbic Acid(UNII: PQ6CK8PD0R)
Titanium Dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-096-019.9 g in 1 CONTAINER Type 0: Not a Combination Product12/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 12/06/2010 09/01/2018
Neutrogena Healthy Skin Compact Makeup Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-097
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone28 mg in 1 g
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate80 mg in 1 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 g
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene90 mg in 1 g
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Isononyl Isononanoate(UNII: S4V5BS6GCX)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Yellow Wax(UNII: 2ZA36H0S2V)
Mica(UNII: V8A1AW0880)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Diethylhexyl 2,6-Naphthalate(UNII: I0DQJ7YGXM)
Dimethicone(UNII: 92RU3N3Y1O)
Phenoxyethanol(UNII: HIE492ZZ3T)
Caprylyl Glycol(UNII: 00YIU5438U)
Levomenol(UNII: 24WE03BX2T)
Pantothenic Acid(UNII: 19F5HK2737)
Vitamin A Palmitate(UNII: 1D1K0N0VVC)
Ascorbic Acid(UNII: PQ6CK8PD0R)
Titanium Dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-097-019.9 g in 1 CONTAINER Type 0: Not a Combination Product12/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 12/06/2010 09/01/2018
Neutrogena Healthy Skin Compact Makeup Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-098
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone28 mg in 1 g
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate80 mg in 1 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate40 mg in 1 g
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene90 mg in 1 g
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone40 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Isononyl Isononanoate(UNII: S4V5BS6GCX)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Yellow Wax(UNII: 2ZA36H0S2V)
Mica(UNII: V8A1AW0880)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
Diethylhexyl 2,6-Naphthalate(UNII: I0DQJ7YGXM)
Dimethicone(UNII: 92RU3N3Y1O)
Phenoxyethanol(UNII: HIE492ZZ3T)
Caprylyl Glycol(UNII: 00YIU5438U)
Levomenol(UNII: 24WE03BX2T)
Pantothenic Acid(UNII: 19F5HK2737)
Vitamin A Palmitate(UNII: 1D1K0N0VVC)
Ascorbic Acid(UNII: PQ6CK8PD0R)
Titanium Dioxide(UNII: 15FIX9V2JP)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-098-019.9 g in 1 CONTAINER Type 0: Not a Combination Product12/06/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 12/06/2010 09/01/2018

PRINCIPAL DISPLAY PANEL

Neutrogena
healthy skin®
compact makeup

with
sunscreen
broad spectrum
SPF 55

helioplex®

Principal Display Panel - 9.9g Container Label - CLASSIC IVORY 10

PRINCIPAL DISPLAY PANEL

Neutrogena
healthy skin®
compact makeup

with
sunscreen
broad spectrum
SPF 55

helioplex®

Principal Display Panel - 9.9g Container Label - NATURAL IVORY 20

PRINCIPAL DISPLAY PANEL

Neutrogena
healthy skin®
compact makeup

with
sunscreen
broad spectrum
SPF 55

helioplex®

Principal Display Panel - 9.9g Container Label - BUFF 30

PRINCIPAL DISPLAY PANEL

Neutrogena
healthy skin®
compact makeup

with
sunscreen
broad spectrum
SPF 55

helioplex®

Principal Display Panel - 9.9g Container Label - NUDE 40

PRINCIPAL DISPLAY PANEL

Neutrogena
healthy skin®
compact makeup

with
sunscreen
broad spectrum
SPF 55

helioplex®

Principal Display Panel - 9.9g Container Label - SOFT BEIGE 50

PRINCIPAL DISPLAY PANEL

Neutrogena
healthy skin®
compact makeup

with
sunscreen
broad spectrum
SPF 55

helioplex®

Principal Display Panel - 9.9g Container Label - NATURAL BEIGE 60

PRINCIPAL DISPLAY PANEL

Neutrogena
healthy skin®
compact makeup

with
sunscreen
broad spectrum
SPF 55

helioplex®

Principal Display Panel - 9.9g Container Label - FRESH BEIGE 70

PRINCIPAL DISPLAY PANEL

Neutrogena
healthy skin®
compact makeup

with
sunscreen
broad spectrum
SPF 55

helioplex®

Principal Display Panel - 9.9g Container Label - WARM BEIGE 90