NDC 11523-7289-1
API & Excipient Details

marketed by MSD Consumer Care, Inc. under NDC Code 11523-7289-1

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Avobenzone(UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	30.63 mg in 1 mL
Homosalate(UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	153.15 mg in 1 mL
Octisalate(UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	51.05 mg in 1 mL
Octocrylene(UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	102.1 mg in 1 mL
Oxybenzone(UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	61.26 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11523-7289-1	237 mL in 1 BOTTLE, PLASTIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	05/12/1993

PRINCIPAL DISPLAY PANEL