NDC Code(s) : 37000-357-50
Packager : The Procter & Gamble Manufacturing Company

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

Olay Regenerist Luminous Brightening and Protecting Avobenzone, Homosalate, Octisalate, and Octocrylene LOTION
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:37000-357
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) 		HOMOSALATE4 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
Inactive Ingredients
Ingredient Name Strength
WATER(UNII: 059QF0KO0R)
GLYCERIN(UNII: PDC6A3C0OX)
NIACINAMIDE(UNII: 25X51I8RD4)
STARCH, TAPIOCA(UNII: 24SC3U704I)
ALUMINUM STARCH OCTENYLSUCCINATE(UNII: I9PJ0O6294)
N-ACETYLGLUCOSAMINE(UNII: V956696549)
DIMETHICONE(UNII: 92RU3N3Y1O)
STEARYL ALCOHOL(UNII: 2KR89I4H1Y)
PANTHENOL(UNII: WV9CM0O67Z)
CETYL ALCOHOL(UNII: 936JST6JCN)
DOCOSANOL(UNII: 9G1OE216XY)
.ALPHA.-TOCOPHEROL ACETATE(UNII: 9E8X80D2L0)
GREEN TEA LEAF(UNII: W2ZU1RY8B0)
BENZYL ALCOHOL(UNII: LKG8494WBH)
HIGH DENSITY POLYETHYLENE(UNII: UG00KM4WR7)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
ISOHEXADECANE(UNII: 918X1OUF1E)
METHYLPARABEN(UNII: A2I8C7HI9T)
NYLON-12(UNII: 446U8J075B)
PEG-100 STEARATE(UNII: YD01N1999R)
ETHYLPARABEN(UNII: 14255EXE39)
ALLANTOIN(UNII: 344S277G0Z)
PROPYLPARABEN(UNII: Z8IX2SC1OH)
SODIUM ASCORBYL PHOSPHATE(UNII: 836SJG51DR)
CETEARYL GLUCOSIDE(UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL(UNII: 2DMT128M1S)
POLYSORBATE 60(UNII: CAL22UVI4M)
STEARIC ACID(UNII: 4ELV7Z65AP)
EDETATE DISODIUM(UNII: 7FLD91C86K)
IODOPROPYNYL BUTYLCARBAMATE(UNII: 603P14DHEB)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:37000-357-501 in 1 CARTON 05/01/2014
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 05/01/2014 11/06/2018

PRINCIPAL DISPLAY PANEL

fades
& helps
prevent
sun spots!

ACTUAL
SIZE

OLAY ®
REGENERIST
LUMINOUS™

brightening
& protecting
lotion
with sunscreen

BROAD SPECTRUM SPF 15
MOISTURIZER

fragrance-free
helps protect against
future discoloration

1.7 FL OZ (50 mL)

Principal Display Panel - 50 mL Bottle Carton