SUPER CREME SOLAIRE CORPS BODY SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]

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  • SUPER CREME SOLAIRE CORPS BODY SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]

SUPER CREME SOLAIRE CORPS BODY SUN CARE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) CREAM [C.F.E.B. SISLEY]
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NDC 66097-004-00
Set ID 1c774aa7-8963-4221-b4b0-b894bd1b941f
Category HUMAN OTC DRUG LABEL
Packager C.F.E.B. Sisley
Generic Name
Product Class
Product Number
Application Number PART352
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  • Drug Facts

  • Active ingredients

    Avobenzone 3 %
    Octinoxate 5 %
    Octisalate 5 %
    Oxybenzone 4 %


    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

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • Children under 6 months of age: ask a doctor.
    • 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 am to 2 pm.
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Other information

    Protect the product in this container from excessive heat or direct sun.

  • Inactive ingredients

    water, dipropylene glycol dibenzoate, butylene glycol, glycerin, butyrospermum parkii (shea butter), helianthus annuus (sunflower) seed oil, isodecyl neopentanoate, dimethicone, physalis alkekengi calyx extract, cetearyl alcohol, lauryl glucoside, polyglyceryl-2 dipolyhydroxystearate, phenoxyethanol, potassium cetyl phosphate, polyacrylamide, carbomer, elaeis guineensis (palm) oil, c13-14 isoparaffin, tocopheryl acetate, lavandula angustifolia (lavender) oil, sodium methyl paraben, allantoin, ceteareth-20, tetrasodium edta, pelargonium graveolens oil, sorbic acid, pentylene glycol, laureth-7, sodium hydroxide, citric acid, cetyl alcohol, bht, potassium sorbate, linalool, limonene, geraniol, citronellol, citral

  • PRINCIPAL DISPLAY PANEL

    SUPER CREME SOLAIRE CORPS  Body sun care   Sunscreen Cream  Broad Spectrum SPF 15  sisley PARIS  6.7 FL.OZ.  200 ml   Sisley USA  7 Renaissance Square, 3rd Floor, White Plains, NY 10601

  • PRINCIPAL DISPLAY PANEL

    b1Box 2Tube

    b2

  • INGREDIENTS AND APPEARANCE
    SUPER CREME SOLAIRE CORPS BODY SUN CARE   SPF 15
    avobenzone, octinoxate, octisalate, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66097-004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SHEANUT OIL (UNII: O88E196QRF)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    PHYSALIS ALKEKENGI CALYX (UNII: AL7F9NO9HR)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    PALM OIL (UNII: 5QUO05548Z)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    METHYLPARABEN SODIUM (UNII: CR6K9C2NHK)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    SORBIC ACID (UNII: X045WJ989B)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    LAURETH-7 (UNII: Z95S6G8201)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    CITRAL (UNII: T7EU0O9VPP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66097-004-001 in 1 BOX01/21/2013
    1200 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/21/2013
    Labeler - C.F.E.B. Sisley (262279246)
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