NDC Code(s) : 10812-536-01
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Neutrogena Ultra Sheer Dry Touch Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10812-536
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 mL
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate150 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate50 mg in 1 mL
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene28 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone60 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Yellow Wax(UNII: 2ZA36H0S2V)
Butylated Hydroxytoluene(UNII: 1P9D0Z171K)
Caprylyl Trisiloxane(UNII: Q95M2P1KJL)
Diethylhexyl 2,6-Naphthalate(UNII: I0DQJ7YGXM)
Dimethicone(UNII: 92RU3N3Y1O)
Glycyrrhizinate Dipotassium(UNII: CA2Y0FE3FX)
Edetate Disodium(UNII: 7FLD91C86K)
Ethylhexylglycerin(UNII: 147D247K3P)
Glyceryl Monostearate(UNII: 230OU9XXE4)
Methylisothiazolinone(UNII: 229D0E1QFA)
PEG-100 Stearate(UNII: YD01N1999R)
Polihexanide(UNII: 322U039GMF)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Water(UNII: 059QF0KO0R)
Xanthan Gum(UNII: TTV12P4NEE)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:10812-536-0188 mL in 1 TUBE Type 0: Not a Combination Product17/10/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 10/17/2012 08/01/2018

PRINCIPAL DISPLAY PANEL

Neutrogena®

Ultra Sheer®
DRY-TOUCH
SUNSCREEN

Broad Spectrum SPF 70
70

helioplex®
broad spectrum uva•uvb

LIGHTWEIGHT
CLEAN FEEL

fast absorbing
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

3.0 FL OZ (88mL)

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label