NDC Code(s) : 11523-7365-1
Packager : Bayer HealthCare LLC.

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Coppertone Clearly Sheer For Sunny Days Avobenzone, homosalate, octisalate, and octocrylene LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11523-7365
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE46.27 mg in 1 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE50.85 mg in 1 mL
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE30.51 mg in 1 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE30.51 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
DIMETHICONE(UNII: 92RU3N3Y1O)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
ETHYLHEXYL ISONONANOATE(UNII: I6KB4GE3K4)
GLYCERIN(UNII: PDC6A3C0OX)
YELLOW WAX(UNII: 2ZA36H0S2V)
GALACTOARABINAN(UNII: SL4SX1O487)
GLYCERYL MONOSTEARATE(UNII: 230OU9XXE4)
PEG-100 STEARATE(UNII: YD01N1999R)
SILICON DIOXIDE(UNII: ETJ7Z6XBU4)
BENZYL ALCOHOL(UNII: LKG8494WBH)
OCTYLDODECANOL(UNII: 461N1O614Y)
TROLAMINE(UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL(UNII: H4N855PNZ1)
CHLORPHENESIN(UNII: I670DAL4SZ)
EDETATE DISODIUM(UNII: 7FLD91C86K)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:11523-7365-1147 mL in 1 BOTTLE, PLASTIC Type 0: Not a Combination Product05/01/2014
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 05/01/2014 12/01/2018

PRINCIPAL DISPLAY PANEL

Coppertone ®
SUNSCREEN LOTION

CLEARLY Sheer ™

FOR SUNNY DAYS

Broad
Spectrum
SPF
15

Won't cause breakouts
Helps leave skin soft
Fast absorbing
Feels clean and light

5 FL OZ (147 mL)

32463-02

Principal Display Panel - 147 mL Bottle Label