Label: ANTI-AGING SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, octinoxate, octisalate and oxybenzone emulsion

  • NDC Code(s): 68026-502-05, 68026-502-50
  • 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.

  • Active Ingredients

    Avobenzone 2.8%           
    Octinoxate 7.5%
    Octisalate 5.0%
    Oxybenzone 4.0%

    Purpose

    Sunscreen

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  • Uses

    • helps prevent sunburn

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  • Warnings

    For external use only

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  • Do not use

    on damaged or broken skin

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  • When using this product

    keep out of eyes. Rinse with water to remove.

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  • Stop use and ask a doctor if

    rash occurs

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  • Keep out of reach of children.

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

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  • Directions:

    • apply daily after cleansing and toning • smooth over face and throat • 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 increase 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

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  • Inactive Ingredients:

    Water(Aqua), Butylene Glycol, Isostearyl Neopentanoate, Glycerin, Coco-Glucoside, Cyclohexasiloxane, Ethoxydiglycol, Peg-100 Stearate, Isononyl Isononanoate, Glyceryl Stearate, Glycoproteins*, Panax Ginseng Root Extract*, Equisetum Arvense (Horsetail) Extract, Olea Europaea (Olive) Oil Unsapoinfiables, Ursolic Acid, Llomastat, Algin, Caprylic/Capric Triglyceride, Coconut Alcohol, Caprylic/Capryl Glucoside, Acacia Senegal Gum, Ascorbyl Tetraisopalmitate, Serine, Tocopherol, DNA, Triticum Vulgare (Wheat) Germ Oil Unsaponifiables, Carnosine, Camellia Sinensis Leaf Extract, Glycine Soja (Soybean) Oil Unsaponifiables, PEG-8, Phospholipids, Plankton Extract, Cyclopentasiloxane, Isodecyl Salicylate, Isopropylbenzyl Salicylate, Pollen Extract, Hydrolyzed Malt Extract, Propylene Glycol, Oligopeptide-5, Angelica Keiskei Extract, Oligopeptide-4, Dimethicone, Lecithin, Silybum Marianum (Lady's Thistle) Fruit Extract, Tocopheryl Linoleate/Oleate, Echium Plantagineum Seed Oil, Polymethyl Methacrylate, Lauroyl Lysine, Sodium Acrylate/Acryloyldimethyl Taurate Copolymer, Sucrose, Xanthan Gum, Disodium EDTA, Alcohol,  Acrylates/C10-30 Alkyl Acrylate Crosscopolymer, Polyisobutene, Carbomer, PPG-2 Isoceteth-20 Acetate, Mica, Fragrance (Parfum),  Benzyl Alcohol, Linalool, Hydroxycitronellal, Alpha-Isomethyl Ionone, Amyl Cinnamal, Hexyl Cinnamal, Evernia Furfuracea (Treemoss) Extract, Geraniol, Benzyl Benzoate, Butylphenyl Methylpropiona, Citronellol, Eugenol, Benzyl Salicylate, Limonene, Phenoxyethanol, Potassium Sorbate, Chlorphenesin, Methylparaben, Benzoic Acid, Ethylparaben  *La Prairie’s exclusive Cellular Complex US Patent 5,840,309

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  • Other Information

    • Protect the product in this container from excessive heat and direct sun

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  • Questions or comments?

    Call toll free 1-800-821-5718 or visit www.laprairie.com

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  • PRINCIPAL DISPLAY PANEL

    ANTI-AGING EMULSION SUNSCREEN BROAD SPECTRUM EMULSION ANTI-AGE CREME SOLAIRE LARGE SPECTRE SPF 30 la prairie SWITZERLAND 50 ml e / 1.7 FL. OZ. MADE IN SWITZERLAND

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  • Product Labels
  • INGREDIENTS AND APPEARANCE
    ANTI-AGING SUNSCREEN BROAD SPECTRUM SPF 30 
    avobenzone, octinoxate, octisalate, oxybenzone emulsion
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68026-502
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 28 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 50 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 40 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    URSOLIC ACID (UNII: P3M2575F3F)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SERINE (UNII: 452VLY9402)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    GLYCINE (UNII: TE7660XO1C)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    SUCROSE (UNII: C151H8M554)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    MICA (UNII: V8A1AW0880)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LINALOOL, DL- (UNII: D81QY6I88E)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    GERANIOL (UNII: L837108USY)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    EUGENOL (UNII: 3T8H1794QW)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68026-502-50 50 mL in 1 BOTTLE
    2 NDC:68026-502-05 5 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 10/22/2013
    Labeler - La Prairie, Inc. (092848621)
    Establishment
    Name Address ID/FEI Business Operations
    Trichema Ag 480006600 manufacture(68026-502)
    Establishment
    Name Address ID/FEI Business Operations
    Frike Cosmetic AG 485853761 manufacture(68026-502)
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