OLAY REGENERIST REGENERATING MOISTURIZER BROAD SPECTRUM SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]

OLAY REGENERIST REGENERATING MOISTURIZER BROAD SPECTRUM SPF 15 (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) LOTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC 69423-049-75
Set ID 03b9b2b1-6cd4-4854-9d91-7ef5c27c5694
Category HUMAN OTC DRUG LABEL
Packager The Procter & Gamble Manufacturing Company
Generic Name
Product Class
Product Number
Application Number PART352
  • 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*, polymethylsilsesquioxane, dimethicone, isopropyl isostearate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, panthenol**, palmitoyl pentapeptide-4***, tocopheryl acetate^, camellia sinensis leaf extract^^, ascorbic acid^^^, allantoin, PTFE, titanium dioxide, stearyl alcohol, caprylyl glycol, behenyl alcohol, 1,2-hexanediol, phenoxyethanol, cetyl alcohol, dimethiconol, PEG-100 stearate, fragrance, sodium benzoate, cetearyl glucoside, cetearyl alcohol, sodium PEG-7 olive oil carboxylate, BHT, disodium EDTA, stearic acid, palmitic acid

  • 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

    15

    ADVANCED ANTI-AGING

    MOISTURIZE

    BROAD SPECTRUM SPF 15

    2.5 FL OZ (75 mL)

    Olay1

  • INGREDIENTS AND APPEARANCE
    OLAY REGENERIST REGENERATING MOISTURIZER  BROAD SPECTRUM SPF 15
    avobenzone, homosalate, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-049
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 mg  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4 mg  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 mg  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.6 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    PALMITOYL PENTAPEPTIDE-4 (UNII: KK181SM5JG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-049-751 in 1 CARTON01/15/2015
    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 not finalpart35201/15/2015
    Labeler - The Procter & Gamble Manufacturing Company (004238200)

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