Label: ANTI-AGING DAY BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate, octocrylene 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 5, 2017

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  • ACTIVE INGREDIENT

    Active ingredients purpose

    Avobenzone 3.0% Sunscreen

    Octinoxate 7.5% Sunscreen

    Octisalate 5.0% Sunscreen

    Octocrylene 2.5% 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 after cleansing and toning

    • smooth over face & 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 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

    Water (Aqua), C12-15 Alkyl Ethylhexanoate, Glycerin, Dimethicone/Vinyl DimethiconeCrosspolymer, Polyglyceryl-3 Methylglucose Distearate, Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Steareth-21, Behenyl Alcohol, Butylene Glycol, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Sodium Hyaluronate, Caprooyl Tetrapeptide-3, Salicornia Herbacea Extract, Sodium PCA, Tocopheryl Acetate, Resveratrol, Acetyl Decapeptide-3, Trehalose, Urea, Larix Sibirica Wood Extract, Palmitoyl Tripeptide-8, Carnosine, Potato Starch Modified, Disodium EDTA, Myrothamnus Flabellifolia Leaf/Stem Extract, Kefiran, Sodium Hydroxide, Glyceryl Stearate, Chlorella Vulgaris Extract, Silica, Panthenol, Polyquaternium-51, Glycine Soja (Soybean) Oil, PEG-100 Stearate, Hydrogenated Lecithin, Allantoin, Hydroxyethyl Behenamidopropyl Dimonium Chloride, C13-14 Isoparaffin, Dextran, Caprylic/Capric Triglyceride, Polysorbate 80, Sodium Oleate, Laureth-7, Cetyl Dimethicone, Caprylyl Glycol, Polyquaternium-67, Steareth-2, Polyacrylamide, Carbomer, Synthetic Wax, Alcohol, Fragrance (Parfum), Linalool, Hexyl Cinnamal, Hydroxycitronellal, Alpha-Isomethyl Ionone, Geraniol, Citronellol, Benzyl Benzoate, Butylphenyl Methylpropional, Evernia Furfuracea (Treemoss) Extract, Eugenol, Benzyl Salicylate, Limonene, Phenoxyethanol, Sorbic Acid, Chlorphenesin, Methylparaben, Benzoic Acid, Yellow 5 (CI 19140), Red 4 (CI 14700)

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  • PRINCIPAL DISPLAY PANEL

    carton

    Anti-Aging Day Cream Sunscreen

    Broad Spectrum

    Creme De Jour Anti-Age Creme Solaire

    Large Spectre

    SPF 30

    La Prairie Switerland

    50 ml/ Net Wt. 1.7 Oz.

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  • INGREDIENTS AND APPEARANCE
    ANTI-AGING DAY BROAD SPECTRUM SPF 30  LA PRAIRIE GROUP AG
    avobenzone, octinoxate, octisalate, octocrylene cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-316
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 g  in 100 kg
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 g  in 100 kg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g  in 100 kg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.5 g  in 100 kg
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    STEARETH-21 (UNII: 53J3F32P58)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    SALICORNIA EUROPAEA (UNII: 6ADL50JAKW)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    RESVERATROL (UNII: Q369O8926L)  
    TREHALOSE (UNII: B8WCK70T7I)  
    UREA (UNII: 8W8T17847W)  
    LARIX SIBIRICA WOOD (UNII: KSC3PGF73L)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    MYROTHAMNUS FLABELLIFOLIA LEAF (UNII: 6Y9E0R40J5)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    ALLANTOIN (UNII: 344S277G0Z)  
    HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    SODIUM OLEATE (UNII: 399SL044HN)  
    LAURETH-7 (UNII: Z95S6G8201)  
    CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    STEARETH-2 (UNII: V56DFE46J5)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    CARBOMER 934 (UNII: Z135WT9208)  
    SYNTHETIC WAX (1800 MW) (UNII: 248P1AUJ90)  
    ALCOHOL (UNII: 3K9958V90M)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    GERANIOL (UNII: L837108USY)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)  
    EUGENOL (UNII: 3T8H1794QW)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBIC ACID (UNII: X045WJ989B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68807-316-11 78.4 kg in 1 DRUM; Type 0: Not a Combination Product 01/16/2013
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part352 01/16/2013
    Labeler - Temmentec AG (480586411)
    Registrant - Temmentec AG (480586411)
    Establishment
    Name Address ID/FEI Business Operations
    Temmentec AG 480586411 manufacture(68807-316)
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