NDC Code(s) : 58232-0805-3
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aveeno Baby Natural Protection Sunscreen Titanium Dioxide and Zinc Oxide CREAM
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58232-0805
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 Dioxide60 mg in 1 g
Zinc Oxide(UNII: SOI2LOH54Z)
(Zinc Oxide - UNII:SOI2LOH54Z) 		Zinc Oxide30 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate(UNII: A9EJ3J61HQ)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
Yellow Wax(UNII: 2ZA36H0S2V)
Butylene Glycol(UNII: 3XUS85K0RA)
Ethylhexylglycerin(UNII: 147D247K3P)
Glyceryl Monostearate(UNII: 230OU9XXE4)
PEG-100 Stearate(UNII: YD01N1999R)
Benzyl Alcohol(UNII: LKG8494WBH)
Dimethicone(UNII: 92RU3N3Y1O)
Arachidyl Alcohol(UNII: 1QR1QRA9BU)
Caprylyl Glycol(UNII: 00YIU5438U)
Trisiloxane(UNII: 9G1ZW13R0G)
Dipropylene Glycol Dibenzoate(UNII: 6OA5ZDY41O)
Glycerin(UNII: PDC6A3C0OX)
Pentylene Glycol(UNII: 50C1307PZG)
Docosanol(UNII: 9G1OE216XY)
Triethoxycaprylylsilane(UNII: LDC331P08E)
Xanthan Gum(UNII: TTV12P4NEE)
Citric Acid Monohydrate(UNII: 2968PHW8QP)
Levomenol(UNII: 24WE03BX2T)
Arachidyl Glucoside(UNII: 6JVW35JOOJ)
PPG-15 Stearyl Ether Benzoate(UNII: 80D2J6361M)
Chlorphenesin(UNII: I670DAL4SZ)
Squalane(UNII: GW89575KF9)
Glycyrrhizinate Dipotassium(UNII: CA2Y0FE3FX)
POLIHEXANIDE(UNII: 322U039GMF)
SODIUM CITRATE, UNSPECIFIED FORM(UNII: 1Q73Q2JULR)
Hydroxyphenyl Propamidobenzoic Acid(UNII: 25KRT26H77)
Polysorbate 60(UNII: CAL22UVI4M)
Oat(UNII: Z6J799EAJK)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:58232-0805-385 g in 1 TUBE Type 0: Not a Combination Product13/09/2012
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 09/13/2012

PRINCIPAL DISPLAY PANEL

Aveeno®
Baby®

natural
protection
100% naturally sourced
sunscreen ingredients
lotion

sunscreen

BROAD
SPECTRUM
SPF 50

for sensitive skin
with soothing oat
fragrance free
sweat + water
resistant (80 min)

PEDIATRICIAN
RECOMMENDED

NET WT. 3 OZ. (85 g)

PRINCIPAL DISPLAY PANEL - 85 g Tube Label