Label: OLAY TOTAL EFFECTS CC TONE CORRECTING BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM- avobenzone, octisalate, and octocrylene cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 12, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Avobenzone 2%Sunscreen
    Octisalate 3%Sunscreen
    Octocrylene 3%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*, titanium dioxide, isopropyl lauroyl sarcosinate, acetyl glucosamine, panthenol**, tocopheryl acetate***, dimethicone, caprylyl glycol, dimethiconol, C13-14 isoparaffin, cetearyl glucoside, cetearyl alcohol, laureth-7, stearyl alcohol, behenyl alcohol, cetyl alcohol, carbomer, polyacrylamide, aminomethyl propanol, citric acid, PEG-100 stearate, 1,2-hexanediol, phenoxyethanol, sodium benzoate, iron oxides.

    *Vitamin B3, **Vitamin B5, ***Vitamin E

  • Questions or comments?

    Call 1-800-285-5170

  • SPL UNCLASSIFIED SECTION

    Distr. by
    PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    COLOR +
    CORRECTION

    CC CREAM

    OLAY ®

    Total Effects ®

    7
    IN
    ONE

    CC

    TONE CORRECTING

    15

    MOISTURIZER with sunscreen

    BROAD SPECTRUM SPF 15

    light to medium

    50 mL (1.7 FL OZ)

    Olay

  • INGREDIENTS AND APPEARANCE
    OLAY TOTAL EFFECTS CC TONE CORRECTING  BROAD SPECTRUM SPF 15 LIGHT TO MEDIUM
    avobenzone, octisalate, and octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37000-355
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3 g  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    LAURETH-7 (UNII: Z95S6G8201)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOPROPYL LAUROYL SARCOSINATE (UNII: LYR06W430J)  
    POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37000-355-501 in 1 CARTON11/07/2013
    150 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 finalpart35211/07/2013
    Labeler - The Procter & Gamble Manufacturing Company (004238200)