NDC Code(s) : 69968-0304-1, 69968-0304-3, 69968-0304-6, 69968-0304-7
Packager : Johnson & Johnson Consumer Inc.

Category : HUMAN OTC DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Aveeno Baby continuous protection sensitive skin Zinc Oxide LOTION
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:69968-0304
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE(UNII: SOI2LOH54Z)
(ZINC OXIDE - UNII:SOI2LOH54Z) 		ZINC OXIDE216 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE(UNII: A9EJ3J61HQ)
PHENYL TRIMETHICONE(UNII: DR0K5NOJ4R)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 5)(UNII: 035JKJ76MT)
DIMETHICONE(UNII: 92RU3N3Y1O)
POLYHYDROXYSTEARIC ACID (2300 MW)(UNII: YXH47AOU0F)
GLYCERIN(UNII: PDC6A3C0OX)
ETHYL METHICONE (8 MPA.S)(UNII: 3YWG8XYT8H)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
CETYL DIMETHICONE 25(UNII: U4AS1BW4ZB)
TRIETHOXYCAPRYLYLSILANE(UNII: LDC331P08E)
PHENYLETHYL ALCOHOL(UNII: ML9LGA7468)
OATMEAL(UNII: 8PI54V663Y)
CAPRYLYL GLYCOL(UNII: 00YIU5438U)
GLYCERYL DIBEHENATE(UNII: R8WTH25YS2)
SODIUM CHLORIDE(UNII: 451W47IQ8X)
CHLORPHENESIN(UNII: I670DAL4SZ)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
FEVERFEW(UNII: Z64FK7P217)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER(UNII: V5RS026Q0H)
OCTYLDODECYL CITRATE CROSSPOLYMER(UNII: X323T6QO4M)
CETYL DIMETHICONE/BIS-VINYLDIMETHICONE CROSSPOLYMER(UNII: AE7QA6TW0Q)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:69968-0304-114 mL in 1 TUBE Type 0: Not a Combination Product10/01/2016
2NDC:69968-0304-388 mL in 1 TUBE Type 0: Not a Combination Product10/01/2016
3NDC:69968-0304-62 in 1 TRAY 20/11/2019
3NDC:69968-0304-388 mL in 1 TUBE Type 0: Not a Combination Product10/01/2016
4NDC:69968-0304-7207 mL in 1 TUBE Type 0: Not a Combination Product12/01/2018
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC Monograph Drug M020 10/01/2016

LABELER - Johnson & Johnson Consumer Inc.(118772437)

PRINCIPAL DISPLAY PANEL

PEDIATRICIAN
RECOMMENDED BRAND
Aveeno
Baby ®
CONTINUOUS
PROTECTION ®
sensitive skin
zinc oxide
sunscreen
BROAD SPECTRUM SPF 50
naturally-sourced 100%
mineral active ingredient
sweat + water resistant
(80 min)
SPF
50
7.0 fl oz (mL)

Principal Display Panel - 207 mL Tube Label