Label: ANTI-AGING EYE BROAD SPECTRUM SPF 15 LA PRAIRIE SWITZERLAND- avbenzone, octinoxate, octisalate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 January 3, 2017

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone 2.0% Sunscreen

    Octinoxate 7.5% Sunscreen

    Octisalate 3.0% Sunscreen

    Uses

    helps prevent sunburn

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

    Stop use and ask a doctor if rash occurs

    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.

    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 of 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

    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)

  • PRINCIPAL DISPLAY PANEL

    carton back

    carton front

    Anti-Aging Eye Cream Sunscreen Broad Spectrum


    Creme Contour Des Yeux Anti-Age Creme Solaire Large Spectre SPF 15

    La Prairie Switzerland 15 ml/ Net Wt. 0.5 Oz

  • INGREDIENTS AND APPEARANCE
    ANTI-AGING EYE BROAD SPECTRUM SPF 15  LA PRAIRIE SWITZERLAND
    avbenzone, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68807-303
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
    GLYCERYL CAPRATE (UNII: 197M6VFC1W)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    EQUISETUM ARVENSE TOP (UNII: 1DP6Y6B65Z)  
    HESPERETIN LAURATE (UNII: HP864VLN2T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    URSOLIC ACID (UNII: P3M2575F3F)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
    CARBOMER 934 (UNII: Z135WT9208)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    SERINE (UNII: 452VLY9402)  
    MILK THISTLE (UNII: U946SH95EE)  
    ACACIA (UNII: 5C5403N26O)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TREHALOSE (UNII: B8WCK70T7I)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)  
    PEG-6 ISOSTEARATE (UNII: 0E2639OTJY)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    UREA (UNII: 8W8T17847W)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    SODIUM ALGINATE (UNII: C269C4G2ZQ)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ISOPROPYLBENZYL SALICYLATE (UNII: 0798EIC152)  
    STEARETH-2 (UNII: V56DFE46J5)  
    CETETH-20 (UNII: I835H2IHHX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIACETIN (UNII: XHX3C3X673)  
    MICA (UNII: V8A1AW0880)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    SUCROSE (UNII: C151H8M554)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ALCOHOL (UNII: 3K9958V90M)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, (+)- (UNII: F4VNO44C09)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68807-303-021 in 1 CARTON01/14/2013
    1NDC:68807-303-0115 mL in 1 JAR; Type 0: Not a Combination Product
    2NDC:68807-303-035 mL in 1 TUBE; Type 0: Not a Combination Product01/14/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35201/14/2013
    Labeler - Temmentec Ag (480586411)
    Registrant - Temmentec Ag (480586411)
    Establishment
    NameAddressID/FEIBusiness Operations
    Temmentec Ag480586411manufacture(68807-303)