Label: OLAY REGENERIST REGENERATING WITH SUNSCREEN BROAD SPECTRUM SPF 15- avobenzone, homosalate, octisalate, and octocrylene lotion

  • NDC Code(s): 69423-719-75
  • Packager: The Procter & Gamble Manufacturing Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated July 10, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    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, niacinamide*, dimethicone, zea mays (corn) starch, isopropyl isostearate, panthenol**, palmitoyl pentapeptide-4***, caprylyl glycol, dimethiconol, cetearyl glucoside, cetearyl alcohol, stearic acid, palmitic acid, stearyl alcohol, cetyl alcohol, behenyl alcohol, disodium EDTA, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-100 stearate, 1,2-hexanediol, phenoxyethanol, fragrance

  • Questions or comments?

    Call 1-800-285-5170

  • SPL UNCLASSIFIED SECTION

    Distr. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

    OLAY ®

    REGENERIST ®

    REGENERATING LOTION

    WITH SUNSCREEN BROAD

    SPECTRUM SPF 15

    ADVANCED FACIAL

    ANTI-AGING

    MOISTURIZE

    BROAD SPECTRUM SPF 15

    75 mL (2.5 FL OZ)

    Olay

  • INGREDIENTS AND APPEARANCE
    OLAY REGENERIST REGENERATING WITH SUNSCREEN BROAD SPECTRUM SPF 15 
    avobenzone, homosalate, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-719
    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) 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 NameStrength
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DIMETHICONOL (50000 CST) (UNII: R2285D73YT)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-719-751 in 1 CARTON01/01/2023
    175 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 finalM02001/01/2023
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
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