Olay ® Professional ProX Anti-Aging Intensive Wrinkle Protocol

ProX by Olay Dermatological Anti-Aging Intensive Wrinkle Protocol by

Drug Labeling and Warnings

ProX by Olay Dermatological Anti-Aging Intensive Wrinkle Protocol by is a Otc medication manufactured, distributed, or labeled by The Procter & Gamble Manufacturing Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PROX BY OLAY DERMATOLOGICAL ANTI-AGING INTENSIVE WRINKLE PROTOCOL- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone 
The Procter & Gamble Manufacturing Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Olay ® Professional ProX Anti-Aging Intensive Wrinkle Protocol

AGE REPAIR LOTION WITH SPF 30


Drug Facts

Active ingredientsPurpose
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?

1-800-285-5170

Deep Wrinkle Treatment

DIRECTIONS

Treat skin morning and night by applying Deep Wrinkle Treatment to areas of concern, such as forehead wrinkles, crow’s feet and wrinkles under the eyes. Recommended for use with an SPF moisturizer.

CAUTION

AVOID CONTACT WITH EYES AND EYELINDS. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITHWATER.

IF SKIN IRRITATION OR SENSITIVITY DEVELOPS, REDUCE FREQUENCY OR DISCONTINUE USE.

KEEP OUT OF REACH OF CHILDREN.

INGREDIENTS

WATER, GLYCERIN, NIACINAMIDE, C12-15 ALKYL BENZOATE, POLYETHYLENE, DIMETHICONE, STEARYL ALCOHOL, CETYL PALMITATE, RETINYL PROPIONATE, PALMITOYL PENTAPEPTIDE-4, PALMITOYL DIPEPTIDE-7, CARNOSINE, PANTHENOL, TOCOPHERYL ACETATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CETYL ALCOHOL, BEHENYL ALCOHOL, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER, ISOHEXADECANE, CETYL RICINOLEATE, DMDM HYDANTOIN, CARBOMER, PEG-100 STEARATE, POLYSORBATE 80, STEARIC ACID, POLYSORBATE 20, DISODIUM EDTA, SODIUM HYDROXIDE, BHT, IODOPROPYNYL BUTYLCARBAMATE

WRINKLE SMOOTHING CREAM

DIRECTIONS

Transform skin day and night by smoothing Wrinkle Smoothing Cream over the face and neck.

CAUTION

AVOID CONTACTWITH EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLYWITH WATER.

INGREDIENTS

WATER, GLYCERIN, DIMETHICONE, NIACINAMIDE, ISOHEXADECANE, ISOPROPYL ISOSTEARATE, DIMETHICONOL, PALMITOYL PENTAPEPTIDE-4, PALMITOYL DIPEPTIDE-7, CARNOSINE, PANTHENOL, TOCOPHERYL ACETATE, HYDROLYZED ELASTIN, CYNARA SCOLYMUS (ARTICHOKE) LEAF EXTRACT, POLYACRYLAMIDE, STEARYL ALCOHOL, PEG-100 STEARATE, CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, TITANIUM DIOXIDE, CETYL ALCOHOL, POLYMETHYLSILSESQUIOXANE, BEHENYL ALCOHOL, C13-14 ISOPARAFFIN, CAPRYLYL GLYCOL, 1,2-HEXANEDIOL, PHENOXYETHANOL, MICA, LAURETH-7, SODIUM BENZOATE, STEARIC ACID, PALMITIC ACID, DISODIUM EDTA, CITRIC ACID

Dist. by PROCTER & GAMBLE,
CINCINNATI, OH 45202

PRINCIPAL DISPLAY PANEL - Kit Carton

PRO XbyOLAY ®

DERMATOLOGICAL

ANTI-AGING

INTENSIVE WRINKLE

PROTOCOL

  • 30 mL (1.0 FL OZ) AGE REPAIR LOTION WITH SUNSCREEN BROAD SPECTRUM SPF 30
  • NET WT 28 G (1.0 OZ) WRINKLE SMOOTHING CREAM
  • 15 mL (0.5 FL OZ) DEEP WRINKLE TREATMENT
  • FRONT
  • BACK
PROX BY OLAY DERMATOLOGICAL ANTI-AGING INTENSIVE WRINKLE PROTOCOL 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69423-442
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69423-442-011 in 1 CARTON; Type 0: Not a Combination Product01/01/202010/01/2020
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PUMP 30 mL
Part 21 TUBE 15 mL
Part 31 JAR 28 g
Part 1 of 3
PROX BY OLAY DERMATOLOGICAL ANTI AGING AGE REPAIR SPF 30 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion
Product Information
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.6 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE6 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
DOCOSANOL (UNII: 9G1OE216XY)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
PEG-100 STEARATE (UNII: YD01N1999R)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
WATER (UNII: 059QF0KO0R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
CARNOSINE (UNII: 8HO6PVN24W)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
ALLANTOIN (UNII: 344S277G0Z)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
PALMITOYL LYSYLTHREONINE (UNII: JHF843U5C5)  
PANTHENOL (UNII: WV9CM0O67Z)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
PALMITIC ACID (UNII: 2V16EO95H1)  
NIACINAMIDE (UNII: 25X51I8RD4)  
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ETHYLPARABEN (UNII: 14255EXE39)  
DIMETHICONOL GUM (UNII: 4MJ9GU3T1P)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
LAURETH-7 (UNII: Z95S6G8201)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
130 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/2020
Part 2 of 3
PROX BY OLAY PROX BY OLAY DERMATOLOGICAL ANTI-AGING DEEP WRINKLE TREATMENT 
face and neck (excluding shaving preparations) lotion
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRDOCOSANOL (UNII: 9G1OE216XY)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRCETYL PALMITATE (UNII: 5ZA2S6B08X)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRBUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGRMEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
INGRCARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
INGRCARNOSINE (UNII: 8HO6PVN24W)  
INGRCETYL RICINOLEATE (UNII: 1P677500YD)  
INGRDMDM HYDANTOIN (UNII: BYR0546TOW)  
INGRIODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRPALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
INGRPALMITOYL LYSYLTHREONINE (UNII: JHF843U5C5)  
INGRISOHEXADECANE (UNII: 918X1OUF1E)  
INGRSODIUM HYDROXIDE (UNII: 55X04QC32I)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRHIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
INGRPOLYSORBATE 20 (UNII: 7T1F30V5YH)  
INGRPOLYSORBATE 80 (UNII: 6OZP39ZG8H)  
INGRRETINYL PROPIONATE (UNII: 32JK994WMC)  
INGRSODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
115 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic12/10/2012
Part 3 of 3
PROX BY OLAY PROX BY OLAY DERMATOLOGICAL ANTI-AGING WRINKLE SMOOTHING CREAM 
moisturizing cream
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER (UNII: 059QF0KO0R)  
INGRGLYCERIN (UNII: PDC6A3C0OX)  
INGRDIMETHICONE (UNII: 92RU3N3Y1O)  
INGRNIACINAMIDE (UNII: 25X51I8RD4)  
INGRPANTHENOL (UNII: WV9CM0O67Z)  
INGRCYNARA SCOLYMUS LEAF (UNII: B71UA545DE)  
INGRISOHEXADECANE (UNII: 918X1OUF1E)  
INGRC13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
INGRHYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)  
INGRSTEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
INGRCARNOSINE (UNII: 8HO6PVN24W)  
INGRDOCOSANOL (UNII: 9G1OE216XY)  
INGRPHENOXYETHANOL (UNII: HIE492ZZ3T)  
INGRCAPRYLYL GLYCOL (UNII: 00YIU5438U)  
INGRPEG-100 STEARATE (UNII: YD01N1999R)  
INGRCETYL ALCOHOL (UNII: 936JST6JCN)  
INGRDIMETHICONOL GUM (UNII: 4MJ9GU3T1P)  
INGRCETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
INGRCETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
INGRSODIUM BENZOATE (UNII: OJ245FE5EU)  
INGRCITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
INGREDETATE DISODIUM (UNII: 7FLD91C86K)  
INGRSTEARIC ACID (UNII: 4ELV7Z65AP)  
INGRPALMITIC ACID (UNII: 2V16EO95H1)  
INGRPALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
INGRPOLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
INGRTITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
INGRISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
INGRLAURETH-7 (UNII: Z95S6G8201)  
INGRMICA (UNII: V8A1AW0880)  
INGRPALMITOYL LYSYLTHREONINE (UNII: JHF843U5C5)  
INGRPOLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)  
INGRALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
11 in 1 CARTON
128 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Cosmetic01/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/01/202010/02/2020
Labeler - The Procter & Gamble Manufacturing Company (004238200)

Revised: 1/2020
 
The Pr

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