LANCOME PARIS ABSOLUE PREMIUM BX BROAD SPECTRUM SPF 15 SUNSCREEN ABSOLUTE REPLENISHING (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]

LANCOME PARIS ABSOLUE PREMIUM BX BROAD SPECTRUM SPF 15 SUNSCREEN ABSOLUTE REPLENISHING (AVOBENZONE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]
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NDC 49967-250-02
Set ID 4a38cc31-7a86-4e64-b247-69a442a5d836
Category HUMAN OTC DRUG LABEL
Packager L'Oreal USA Products Inc
Generic Name
Product Class
Product Number
Application Number PART352
  • Active ingredients

    Avobenzone 3%

    Octisalate 3%

    Octocrylene 8%

  • Purpose

    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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    For sunscreen use:

    ● apply generously and evenly 15 minutes before sun exposure

    ● reapply at least every 2 hours

    ● use a 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 the sun, especially from 10 a.m. – 2 p.m.

    ● wear long-sleeved shirts, pants, hats, and sunglasses

    ● children under 6 months of age: Ask a doctor

  • Other information

    protect the product in this container from excessive heat and direct sun

  • Inactive ingredients

    water, glycerin, cyclohexasiloxane, alcohol denat., caprylic/capric triglyceride, PEG-20 methyl glucose sesquistearate, C12-15 alkyl benzoate, tocopheryl acetate, C13-14 isoparaffin, hydroxypropyl tetrahydropyrantriol, hydrolyzed malt extract, padina pavonica extract, hydrolyzed soy protein, stearic acid, adenosine, triethanolamine, polyacrylamide, calcium pantothenate, dimethyl isosorbide, limonene, xanthan gum, linalool, dioscorea villosa (wild yam) root extract, iron oxides, caprylyl glycol, capryloyl salicylic acid, paraffin, disodium EDTA, butylene glycol, cetyl alcohol, octyldodecanol, citronellol, laureth-7, hexyldecanol, fragrance

  • Questions or comments?

    1-800-LANCOME (1-800-526-2663)

    Monday - Friday (9 a.m. - 5 p.m. EST)

  • PRINCIPAL DISPLAY PANEL

    image of a carton

  • INGREDIENTS AND APPEARANCE
    LANCOME PARIS ABSOLUE PREMIUM BX BROAD SPECTRUM SPF 15 SUNSCREEN ABSOLUTE REPLENISHING 
    avobenzone, octisalate and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49967-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    ALCOHOL (UNII: 3K9958V90M)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PEG-20 METHYL GLUCOSE SESQUISTEARATE (UNII: 0345752X7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    HYDROXYPROPYL TETRAHYDROPYRANTRIOL (UNII: 4U3GMG1OT1)  
    PADINA PAVONICA (UNII: 177U06NHZI)  
    HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ADENOSINE (UNII: K72T3FS567)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    POLYACRYLAMIDE (CROSSLINKED; 2 MOLE PERCENT BISACRYLAMIDE) (UNII: 9FPL31B58Q)  
    CALCIUM PANTOTHENATE (UNII: 568ET80C3D)  
    DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAPRYLOYL SALICYLIC ACID (UNII: 5F7PJF6AA4)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LAURETH-7 (UNII: Z95S6G8201)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49967-250-021 in 1 CARTON02/01/2010
    175 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2010
    Labeler - L'Oreal USA Products Inc (002136794)
    Establishment
    NameAddressID/FEIBusiness Operations
    SICOS ET CIE276993581manufacture(49967-250)
    Establishment
    NameAddressID/FEIBusiness Operations
    BPS60272259304pack(49967-250)

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