NDC Code(s) : 10812-192-01
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Neutrogena Fresh Cooling Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone AEROSOL, SPRAY
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-192
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30 mg in 1 g
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate150 mg in 1 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate50 mg in 1 g
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene23.5 mg in 1 g
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone60 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Ascorbyl Palmitate(UNII: QN83US2B0N)
Cyclomethicone 5(UNII: 0THT5PCI0R)
Diethylhexyl 2,6-Naphthalate(UNII: I0DQJ7YGXM)
Dimethicone(UNII: 92RU3N3Y1O)
Diethylene Glycol Monoethyl Ether(UNII: A1A1I8X02B)
Isobutane(UNII: BXR49TP611)
Lauryl PCA(UNII: 29C5O2BJYA)
Menthyl Pyrrolidone Carboxylate, (-),DL-(UNII: 8P18J856U2)
PPG-5-Ceteth-20(UNII: 4AAN25P8P4)
Propylene Glycol(UNII: 6DC9Q167V3)
Vitamin A Palmitate(UNII: 1D1K0N0VVC)
.Alpha.-Tocopherol Acetate(UNII: 9E8X80D2L0)
Trisiloxane(UNII: 9G1ZW13R0G)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-192-01141 g in 1 CAN Type 0: Not a Combination Product18/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 10/18/2012 08/05/2018

PRINCIPAL DISPLAY PANEL

Neutrogena®

Fresh
Cooling
SUNSCREEN
Broad Spectrum
SPF 45

helioplex®
broad spectrum uva•uvb

INSTANTLY COOLS
AS IT PROTECTS

refreshes with every application
non-greasy
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

NET WT 5.0 OZ (141 g)

PRINCIPAL DISPLAY PANEL - 141 g Can Label