NDC Code(s) : 11523-7289-1
Packager : MSD Consumer Care, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Coppertone Water Babies Sunscreen Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11523-7289
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Avobenzone(UNII: G63QQF2NOX)
(Avobenzone - UNII:G63QQF2NOX) 		Avobenzone30.63 mg in 1 mL
Homosalate(UNII: V06SV4M95S)
(Homosalate - UNII:V06SV4M95S) 		Homosalate153.15 mg in 1 mL
Octisalate(UNII: 4X49Y0596W)
(Octisalate - UNII:4X49Y0596W) 		Octisalate51.05 mg in 1 mL
Octocrylene(UNII: 5A68WGF6WM)
(Octocrylene - UNII:5A68WGF6WM) 		Octocrylene102.1 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y)
(Oxybenzone - UNII:95OOS7VE0Y) 		Oxybenzone61.26 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
butylene glycol(UNII: 3XUS85K0RA)
cellulose, microcrystalline(UNII: OP1R32D61U)
glyceryl monostearate(UNII: 230OU9XXE4)
Docosanol(UNII: 9G1OE216XY)
Benzyl Alcohol(UNII: LKG8494WBH)
diethylhexyl syringylidenemalonate(UNII: 3V5U97P248)
.Alpha.-Tocopherol(UNII: H4N855PNZ1)
Vitamin A(UNII: 81G40H8B0T)
sodium ascorbyl phosphate(UNII: 836SJG51DR)
stearic acid(UNII: 4ELV7Z65AP)
palmitic acid(UNII: 2V16EO95H1)
lauryl alcohol(UNII: 178A96NLP2)
myristyl alcohol(UNII: V42034O9PU)
chlorphenesin(UNII: I670DAL4SZ)
carboxymethylcellulose sodium(UNII: K679OBS311)
Edetate Disodium(UNII: 7FLD91C86K)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11523-7289-1237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part352 05/12/1993

PRINCIPAL DISPLAY PANEL

Coppertone®
SUNSCREEN LOTION

water
BABIES®

Broad
Spectrum
SPF
70+

#1 PEDIATRICIAN
RECOMMENDED BRAND

Water Resistant
(80 minutes)

70+

8 FL OZ (237 mL)

Principal Display Panel - 237 mL Bottle Label