NDC Code(s) : 11523-7291-1
Packager : MSD Consumer Care, Inc.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Coppertone avobenzone, homosalate, octisalate, and octocrylene LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11523-7291
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
avobenzone(UNII: G63QQF2NOX)
(avobenzone - UNII:G63QQF2NOX) 		avobenzone20.06 mg in 1 mL
homosalate(UNII: V06SV4M95S)
(homosalate - UNII:V06SV4M95S) 		homosalate100.3 mg in 1 mL
octisalate(UNII: 4X49Y0596W)
(octisalate - UNII:4X49Y0596W) 		octisalate50.15 mg in 1 mL
octocrylene(UNII: 5A68WGF6WM)
(octocrylene - UNII:5A68WGF6WM) 		octocrylene50.15 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
Water(UNII: 059QF0KO0R)
Sorbitol(UNII: 506T60A25R)
Ethylhexyl Palmitate(UNII: 2865993309)
Benzyl Alcohol(UNII: LKG8494WBH)
Dimethicone(UNII: 92RU3N3Y1O)
.Alpha.-Tocopherol(UNII: H4N855PNZ1)
Cetyl Phosphate(UNII: VT07D6X67O)
Aloe Vera Leaf(UNII: ZY81Z83H0X)
Trolamine(UNII: 9O3K93S3TK)
Edetate Disodium(UNII: 7FLD91C86K)
Chlorphenesin(UNII: I670DAL4SZ)
Product Characteristics
Color WHITE (white to light yellow) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11523-7291-1237 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 05/21/1999

PRINCIPAL DISPLAY PANEL

®

Coppertone®

oil
free

Sunscreen
Lotion

™

fragrance free
hypoallergenic
won't clog pores

Broad
Spectrum
SPF
15

Pure & Simple
Sun Protection

Water Resistant (80 Minutes)

15

8 FL OZ (237 mL)

21886-FE

Principal Display Panel - 237 mL Bottle Label