OLAY PROFESSIONAL PROX AGE REPAIR BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Olay Professional ProX by

Drug Labeling and Warnings

Olay Professional ProX 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 15.0%	Sunscreen
Octisalate 5.0%	Sunscreen
Octocrylene 2.6%	Sunscreen
Oxybenzone 6.0%	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, niacinamide, polymethylsilsesquioxane, polyethylene, pentylene glycol, palmitoyl pentapeptide-4, palmitoyl dipeptide-7, carnosine, panthenol, tocopheryl acetate, allantoin, camellia sinensis leaf extract, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, benzyl alcohol, titanium dioxide, stearyl alcohol, behenyl alcohol, PEG-100 stearate, cetyl alcohol, methylparaben, polyacrylamide, propylparaben, ethylparaben, cetearyl glucoside, cetearyl alcohol, C13-14 isoparaffin, dimethiconol, sodium ascorbyl phosphate, citric acid, BHT, disodium EDTA, laureth-7, stearic acid, palmitic acid, iodopropynyl butylcarbamate.

Questions or comments?

1-800-285-5170

SPL UNCLASSIFIED SECTION

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

PRO X by OLAY ®

DERMATOLOGICAL ANTI-AGING

AGE REPAIR LOTION WITH

SUNSCREEN BROAD SPECTRUM
SPF 30

75 mL (2.5 FL OZ)

INGREDIENTS AND APPEARANCE

OLAY PROFESSIONAL PROX  AGE REPAIR BROAD SPECTRUM SPF 30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37000-232
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	1.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.6 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
NIACINAMIDE (UNII: 25X51I8RD4)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
DIMETHICONE (UNII: 92RU3N3Y1O)
PALMITOYL LYSYLTHREONINE (UNII: JHF843U5C5)
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)
CARNOSINE (UNII: 8HO6PVN24W)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETYL ALCOHOL (UNII: 936JST6JCN)
PEG-100 STEARATE (UNII: YD01N1999R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ALLANTOIN (UNII: 344S277G0Z)
METHYLPARABEN (UNII: A2I8C7HI9T)
ETHYLPARABEN (UNII: 14255EXE39)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZYL ALCOHOL (UNII: LKG8494WBH)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
LAURETH-7 (UNII: Z95S6G8201)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
STEARIC ACID (UNII: 4ELV7Z65AP)
PALMITIC ACID (UNII: 2V16EO95H1)
POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)
DOCOSANOL (UNII: 9G1OE216XY)
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37000-232-75	1 in 1 CARTON	06/01/2012
1		75 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
2	NDC: 37000-232-30	1 in 1 CARTON	06/01/2012
2		30 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	06/01/2012

Labeler - The Procter & Gamble Manufacturing Company (004238200)

Establishment
Name	Address	ID/FEI	Business Operations
The Procter & Gamble Manufacturing Company		017745779	manufacture(37000-232)