Label: SUN PROTECTION EMULSION FACE BROAD SPECTRUM SPF 30 LA PRAIRIE GROUP- avobenzone, homosalate, octisalate, octocrylene, oxybenzone 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 25, 2016

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  • ACTIVE INGREDIENT

    Active ingredients     Purpose

    Avobenzone 3.0%    Sunscreen

    Homosalate  10.0%  Sunscreen

    Octisalate 2.6%        Sunscreen

    Octocrylene 2.4%     Sunscreen

    Oxybenzone 5.0%     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 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

    Inactive Ingredients

    Water (Aqua), Caprylyl Methicone, Hexyldecanol, Dimethicone, Polyglyceryl-3 Methylglucose Distearate, Undercrylene Dimethicone, Aluminum Starch Octenylsuccinate, Steareth-21, Octyldodecyl Olivate, Cetyl Alcohol, Silica, Glycerin, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Sodium Hyalu-ronate, Corallina Officinalis Extract, Sea Water (Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dime- thoxydimethylindanone, Sodium Hydroxide, Porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Palmata Extract, Tocopheryl Acetate, Diethylhexyl Syringyldenemalonate, Pelvetia Canaliculata Extract, Polysorbate 60, Lecithin, Caprylic/Capric Triglyceride, Sodium Lactate, Caprylyl Glycol, Alcohol, Benzyl Alcohol, Fragrance (Parfum), Phenoxyethanol, Chlorphenesin, Sodium Benzoate, Methylparaben, Ethylparaben, Propylparaben.

  • PRINCIPAL DISPLAY PANEL

    tube

    carton

    Sun Protection Emulsion Face

    Emulsion Solaire Protectrice Visage

    Sunscreen Broad Spectrum SPF 30

    La Prairie Switzerland


    125 ml 4.2 Fl. Oz.

  • INGREDIENTS AND APPEARANCE
    SUN PROTECTION EMULSION FACE BROAD SPECTRUM SPF 30  LA PRAIRIE GROUP
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68807-321
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 kg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.6 g  in 100 kg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.4 g  in 100 kg
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5 g  in 100 kg
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    HEXYLDECANOL (UNII: 151Z7P1317)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    CORALLINA OFFICINALIS (UNII: 4004498D06)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARETH-2 (UNII: V56DFE46J5)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SQUALANE (UNII: GW89575KF9)  
    CARBOMER 934 (UNII: Z135WT9208)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    DULSE (UNII: 7832HOY4ZQ)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    PELVETIA CANALICULATA (UNII: 8U1M44KESN)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68807-321-1178.4 kg in 1 DRUM; Type 0: Not a Combination Product02/14/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/14/2011
    Labeler - Temmentec Ag (480586411)
    Registrant - Temmentec Ag (480586411)
    Establishment
    NameAddressID/FEIBusiness Operations
    Temmentec Ag480586411manufacture(68807-321)