OLAY COMPLETE UV365 DAILY MOISTURIZER SENSITIVE PLUS BROAD SPECTRUM SPF 15 (OCTINOXATE AND ZINC OXIDE) LOTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]

OLAY COMPLETE UV365 DAILY MOISTURIZER SENSITIVE PLUS BROAD SPECTRUM SPF 15 (OCTINOXATE AND ZINC OXIDE) LOTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]
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NDC 69423-264-02
Set ID 6801bbe8-53e7-7d12-e053-2a91aa0a51a7
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
    Octinoxate 6%Sunscreen
    Zinc Oxide 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, isohexadecane, aloe barbadensis leaf extract, tocopheryl acetate*, BHT, cyclopentasiloxane, C13-14 isoparaffin, steareth-21, PEG/PPG-20/20 dimethicone, laureth-7, steareth-2, stearyl alcohol, behenyl alcohol, cetyl alcohol, disodium EDTA, polyacrylamide, oleth-3 phosphate, triethoxycaprylylsilane, DMDM hydantoin, iodopropynyl butylcarbamate.

    *Vitamin E

  • Questions or comments?

    Call 1-800-285-5170

  • SPL UNCLASSIFIED SECTION

    Distr. by PROCTER & GAMBLE,
    CINCINNATI, OH 45202

  • PRINCIPAL DISPLAY PANEL - 177 mL Bottle Package

    OLAY ®

    COMPLETE

    UV365 Daily Moisturizer

    with Sunscreen

    BROAD SPECTRUM SPF 15
    SENSITIVE PLUS

    2 Bottles, 177 mL (6.0 FL OZ) EACH, TOTAL 354 mL (12.0 FL OZ)

    Olay Sens Plus Twin Pack

  • INGREDIENTS AND APPEARANCE
    OLAY COMPLETE UV365 DAILY MOISTURIZER SENSITIVE PLUS  BROAD SPECTRUM SPF 15
    octinoxate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69423-264
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOHEXADECANE (UNII: 918X1OUF1E)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PEG/PPG-20/20 DIMETHICONE (UNII: BA94B7CK8K)  
    STEARETH-2 (UNII: V56DFE46J5)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAURETH-7 (UNII: Z95S6G8201)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69423-264-022 in 1 PACKAGE01/31/2018
    1177 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/31/2018
    Labeler - The Procter & Gamble Manufacturing Company (004238200)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Procter & Gamble Manufacturing Company017745779manufacture(69423-264) , pack(69423-264)

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