Label: SISLEYA GLOBAL ANTI-AGE HAND CARE SPF 15- avobenzone, octinoxate, octisalate cream

  • NDC Code(s): 66097-001-04, 66097-001-76
  • Packager: C.F.E.B. Sisley
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 30, 2023

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  • Drug Facts


  • Active Ingredients

    Avobenzone 2% Octinoxate 5% Octisalate 3%


    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
  • 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
    • Spending time in the sun increases our 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: Sun Protection Measures.
    • 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 from excessive heat or direct sun.

  • Inactive ingredients

    water, tribehenin peg-20 esters, sorbitol, isodecyl neopentanoate, butyrospermum parkii (shea butter), tropaeolum majus flower extract, helianthus annuus (sunflower) seed oil, glycyrrhiza glabra (licorice) root extract, harpagophytum procumbens root extract, cyclopentasiloxane, propylene glycol, phenoxyethanol, tocopheryl acetate, panthenol, pyrus malus (apple) seed extract, hexyldecanol, potassium cetyl phosphate, benzoic acid, sodium hydroxide, c12-13 pareth-23, methylparaben, aniba rosaeodora (rosewood) wood oil,edetate sodium, allantoin, c13-14 isoparaffin, retinyl palmitate, lavandula angustifolia (lavender) oil, pelargonium graveolens oil, caprylic/capric triglyceride, ethylparaben, citric acid, laureth-7, propylparaben, bht, ethylhexylglycerin, tocopherol, linalool, limonene, geraniol, citronellol, benzyl benzoate

  • PRINCIPAL DISPLAY PANEL

    SISLEYA  Global Anti-Age  Hand care   Sunscreen Cream Broad Spectrum SPF 15  NET WT. 0.14 OZ.  4 g  sisley PARIS   Sisley USA 7 Renaissance Square, 3rd Floor, White Plains, NY 10601   Distributed by:  C.F.E.B. sisley 16, avenue George V 75008 PARIS  www.sisley-usa.com  Made in France

  • Product Labels

    TubeBox

  • INGREDIENTS AND APPEARANCE
    SISLEYA GLOBAL ANTI-AGE HAND CARE   SPF 15
    avobenzone, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66097-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE50 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TRIBEHENIN PEG-20 ESTERS (UNII: 84K9EH29Y9)  
    SORBITOL (UNII: 506T60A25R)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    SHEANUT OIL (UNII: O88E196QRF)  
    TROPAEOLUM MAJUS FLOWER (UNII: 7FV667B00B)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    APPLE SEED (UNII: 33C88SEV0Z)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    C12-13 PARETH-23 (UNII: J1WW1510L4)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ROSEWOOD OIL (UNII: F2522O5L7B)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALLANTOIN (UNII: 344S277G0Z)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    GERANIUM OIL, ALGERIAN TYPE (UNII: 5Q1I94P4WG)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    GERANIOL (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66097-001-041 in 1 BOX01/20/2013
    14 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:66097-001-761 in 1 BOX01/20/2013
    276 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/20/2013
    Labeler - C.F.E.B. Sisley (262279246)
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