OLAY AGE DEFYING ANTI-WRINKLE DAY BROAD SPECTRUM SPF 15- avobenzone, homosalate, octisalate, and octocrylene lotion

Olay Age Defying Anti-Wrinkle Day by

Drug Labeling and Warnings

Olay Age Defying Anti-Wrinkle Day by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
Avobenzone 3.0%	Sunscreen
Homosalate 4.0%	Sunscreen
Octisalate 4.5%	Sunscreen
Octocrylene 2.6%	Sunscreen

Uses

• helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months: ask a doctor

Other information

• protect this product from excessive heat and direct sun

Inactive ingredients

Water, glycerin, polyethylene, niacinamide, dimethicone, isopropyl isostearate, propylene glycol, aloe barbadensis leaf extract, panthenol, tocopheryl acetate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, titanium dioxide, stearyl alcohol,

caprylyl glycol, behenyl alcohol, 1,2-hexanediol, phenoxyethanol, cetyl alcohol, dimethiconol, PEG-100 stearate, sodium benzoate, cetearyl glucoside, cetearyl alcohol, fragrance, disodium EDTA, stearic acid, palmitic acid, citric acid.

Questions or comments?

Call 1-800-285-5170

SPL UNCLASSIFIED SECTION

Dist. by
PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

OLAY ®

AGE DEFYING

ANTI-WRINKLE

15

day lotion
with sunscreen

BROAD SPECTRUM SPF 15

100 mL (3.4 FL OZ)

INGREDIENTS AND APPEARANCE

OLAY AGE DEFYING ANTI-WRINKLE DAY  BROAD SPECTRUM SPF 15
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69423-089
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PALMITIC ACID (UNII: 2V16EO95H1)
DIMETHICONOL GUM (UNII: 4MJ9GU3T1P)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PANTHENOL (UNII: WV9CM0O67Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DOCOSANOL (UNII: 9G1OE216XY)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69423-089-10	1 in 1 CARTON	01/19/2016
1		100 mL in 1 BOTTLE, PLASTIC; 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	01/19/2016

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
The Procter & Gamble Manufacturing Company		017745779	manufacture(69423-089) , pack(69423-089)