Label: ANTI-AGING EYE SUNSCREEN BROAD SPECTRUM SPF 15 - avobenzone, octinoxate and octisalate cream

  • NDC Code(s): 68026-501-03, 68026-501-15
  • Packager: La Prairie, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/13

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

  • ANTI-AGING EYE CREAM SUNSCREEN BROAD SPECTRUM SPF 15
  • Active Ingredients

    Avobenzone 2.0%
    Octinoxate 7.5%
    Octisalate 3.0%

    Close
  • Purpose

    Sunscreen

    Close
  • Uses

    • helps prevent sunburn
    Close
  • 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.


    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

    Close
  • Directions

    • apply daily under the eye and along the brow line
    • apply liberally 15 minutes before sun exposure
    • children under 6 months of age: Ask a doctor
    • 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-sleeve shirts, pants, hats, and sunglasses
    Close
  • Inactive Ingredients

    Water (Aqua), Cetearyl Alcohol, Soybean Glycerides, Butyrospermum Parkii (Shea Butter) Unsaponifiables, Polyethylene, Myristyl Myristate, Ethoxydiglycol, Butylene Glycol, Synthetic Beeswax, Glyceryl Caprylate, Glycoproteins*,
    Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract*, Hesperetin Laurate,  Saccharomyces/Xylinum/Black Tea Ferment, Tocopherol, Hydrolyzed Malt Extract, Lecithin, Olea Europaea (Olive) Oil Unsaponifiables, Ursolic Acid, Erythrityl Triethylhexanoate, Plankton Extract, Ilomastat, Carnosine, Echium Plantagineum Seed Oil, Carbomer, Caprylyl/Capryl Glucoside, Serine, Silybum Marianum Fruit Extract, Acacia Senegal Gum, Ascorbyl Tetraisopalmitate, Triticum Vulgare (Wheat) Germ Oil Unsaponifiables, Hydroxyethylcellulose, Lauroyl Lysine, Melissa Officinalis Leaf Extract, PEG-8, Pollen Extract, Hydrogenated Lecithin, Glycerin, Trehalose, Glycine Soja (Soybean) Oil Unsaponifiables, Polyquaternium-51, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Sodium Acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, PEG-6 Isostearate, Propylene Glycol, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Urea, Sodium PCA, Isodecyl Salicylate, Tocopheryl Linoleate/Oleate, Algin, Disodium EDTA, Isopropylbenzyl Salicylate, Steareth-2, Phospholipids, DNA, Polyisobutene, Ceteth-20, Xanthan Gum, Triacetin, Mica, Cyclomethicone, Polymethyl Methacrylate, Steareth-21, Cyclohexasiloxane, Sucrose, Stearic Acid, Alcohol, Aluminum Hydroxide, Fragrance (Parfum), Benzyl Alcohol, Linalool, Hydroxycitronellal, Alpha-Isomethyl Ionone, Amyl Cinnamal, Hexyl Cinnamal, Evernia Furfuracea (Treemoss) Extract, Geraniol, Benzyl Benzoate, Butylphenyl Methylpropional, Phenoxyethanol, Benzoic Acid, Methylparaben, Potassium Sorbate, Chlorphenesin, Ethylparaben, Butylparaben, Propylparaben, Isobutylparaben, Titanium Dioxide (CI 77891)

    Close
  • Other Information

    • Protect the product in this container from excessive heat and direct sun
    Close
  • Questions or Comments?

    • Call toll free 1-800-821-5718 or visit www.laprairie.com
    Close
  • ANTI-AGING EYE CREAM SUNCREEN BROAD SPECTRUM SPF 15 15ml (68026-501-15) | ANTI-AGING EYE CREAM SUNCREEN BROAD SPECTRUM SPF 15 3ml (68026-501-03)
  • INGREDIENTS AND APPEARANCE
    ANTI-AGING EYE SUNSCREEN BROAD SPECTRUM SPF 15  
    avobenzone, octinoxate, octisalate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68026-501
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 20 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 30 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SHEANUT OIL (UNII: O88E196QRF)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    URSOLIC ACID (UNII: P3M2575F3F)  
    ILOMASTAT (UNII: I0403ML141)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SERINE (UNII: 452VLY9402)  
    SILYBUM MARIANUM SEED (UNII: U946SH95EE)  
    ACACIA (UNII: 5C5403N26O)  
    WHEAT GERM OIL (UNII: 14C97E680P)  
    HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TREHALOSE (UNII: B8WCK70T7I)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    UREA (UNII: 8W8T17847W)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    STEARETH-2 (UNII: V56DFE46J5)  
    HERRING SPERM DNA (UNII: 51FI676N6F)  
    POLYISOBUTYLENE (1200000 MW) (UNII: FLT10CH37X)  
    CETETH-20 (UNII: I835H2IHHX)  
    MICA (UNII: V8A1AW0880)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, DL- (UNII: D81QY6I88E)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)  
    GERANIOL (UNII: L837108USY)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68026-501-15 15 mL in 1 BOTTLE
    2 NDC:68026-501-03 3 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 04/12/2011
    Labeler - La Prairie, Inc. (092848621)
    Establishment
    Name Address ID/FEI Business Operations
    Trichema Ag 480006600 manufacture(68026-501)
    Establishment
    Name Address ID/FEI Business Operations
    Frike Cosmetic AG 485853761 manufacture(68026-501)
    Close