NDC Code(s) : 58232-0809-3
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aveeno Active Naturals Protect Plus Hydrate Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58232-0809
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) 		Homosalate100 mg in 1 g
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate50 mg in 1 g
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene60 mg in 1 g
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Glycerin(UNII: PDC6A3C0OX)
Silicon Dioxide(UNII: ETJ7Z6XBU4)
Dimethicone(UNII: 92RU3N3Y1O)
Ethylhexylglycerin(UNII: 147D247K3P)
Yellow Wax(UNII: 2ZA36H0S2V)
Benzyl Alcohol(UNII: LKG8494WBH)
Glyceryl Monostearate(UNII: 230OU9XXE4)
PEG-100 Stearate(UNII: YD01N1999R)
Docosanol(UNII: 9G1OE216XY)
Phenoxyethanol(UNII: HIE492ZZ3T)
Caprylyl Glycol(UNII: 00YIU5438U)
Caprylyl Trisiloxane(UNII: Q95M2P1KJL)
Propylene Glycol(UNII: 6DC9Q167V3)
Chlorphenesin(UNII: I670DAL4SZ)
Arachidyl Alcohol(UNII: 1QR1QRA9BU)
Edetate Disodium(UNII: 7FLD91C86K)
Diethylhexyl 2,6-Naphthalate(UNII: I0DQJ7YGXM)
Sodium Hydroxide(UNII: 55X04QC32I)
Stearyl Alcohol(UNII: 2KR89I4H1Y)
Oatmeal(UNII: 8PI54V663Y)
Cetyl Alcohol(UNII: 936JST6JCN)
1-Tetracosanol(UNII: 2N0PI37IOC)
Oat(UNII: Z6J799EAJK)
Codium Tomentosum(UNII: B8B45BRU87)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58232-0809-385 g in 1 TUBE 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 07/12/2012 03/04/2018

PRINCIPAL DISPLAY PANEL

Aveeno®
ACTIVE NATURALS®

protect +
hydrate™
lotion
sunscreen

BROAD
SPECTRUM
SPF 50
FOR FACE

oil-free
non-comedogenic

with nourishing oat

sweat + water
resistant (80 min)

DERMATOLOGIST
RECOMMENDED

NET WT. 3 OZ. (85g)

Principal Display Panel - 85 g Tube Label