NDC Code(s) : 37000-249-50
Packager : The Procter & Gamble Manufacturing Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Olay Professional ProX Anti-Oxidant Sheer Daily Moisturizer Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37000-249
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
AVOBENZONE(UNII: G63QQF2NOX)
(AVOBENZONE - UNII:G63QQF2NOX) 		AVOBENZONE3 g in 100 mL
HOMOSALATE(UNII: V06SV4M95S)
(HOMOSALATE - UNII:V06SV4M95S) 		HOMOSALATE9 g in 100 mL
OCTISALATE(UNII: 4X49Y0596W)
(OCTISALATE - UNII:4X49Y0596W) 		OCTISALATE4.5 g in 100 mL
OCTOCRYLENE(UNII: 5A68WGF6WM)
(OCTOCRYLENE - UNII:5A68WGF6WM) 		OCTOCRYLENE2.6 g in 100 mL
OXYBENZONE(UNII: 95OOS7VE0Y)
(OXYBENZONE - UNII:95OOS7VE0Y) 		OXYBENZONE2 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
PENTYLENE GLYCOL(UNII: 50C1307PZG)
NYLON-12(UNII: 446U8J075B)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
GLYCERIN(UNII: PDC6A3C0OX)
DIMETHICONE(UNII: 92RU3N3Y1O)
ISOHEXADECANE(UNII: 918X1OUF1E)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
BUTYLENE GLYCOL(UNII: 3XUS85K0RA)
DOCOSANOL(UNII: 9G1OE216XY)
PHENOXYETHANOL(UNII: HIE492ZZ3T)
BENZYL ALCOHOL(UNII: LKG8494WBH)
CETYL ALCOHOL(UNII: 936JST6JCN)
PEG-100 STEARATE(UNII: YD01N1999R)
POLYSORBATE 80(UNII: 6OZP39ZG8H)
SODIUM BENZOATE(UNII: OJ245FE5EU)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
CETEARYL GLUCOSIDE(UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
EDETATE DISODIUM(UNII: 7FLD91C86K)
STEARIC ACID(UNII: 4ELV7Z65AP)
SACCHARINA LATISSIMA(UNII: 68CMP2MB55)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-249-501 in 1 CARTON 10/12/2012
150 mL in 1 BOTTLE, PUMP Type 0: Not a Combination Product
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part352 12/10/2012 05/04/2018

PRINCIPAL DISPLAY PANEL

NEW

OLAY ®
PROFESSIONAL

PRO x
even skin tone

ANTI-OXIDANT SUNSCREEN
SHEER DAILY MOISTURIZER

BROAD SPECTRUM
SPF 35

35

1.7 FL OZ (50 mL)

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton