Label: SUN PROTECTION BODY SUNSCREEN BROAD SPECTRUM SPF 30 LA PRAIRIE- avobenzone, homosalate, octisalate, oxybenzone lotion

  • 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 Ingredients        Purpose

    Avobenzone 3.0%          Sunscreen

    Homosalate 7.0 %          Sunscreen

    Octisalate 5.0%              Sunscreen

    Oxybenzone 5.0%          Sunscreen

    Uses

    helps prevent sunburn

    warning

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

    indications

    Stop use and ask a doctor if rash occurs.

    warnings

    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 body

      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, Undecrylene Dimethicone, Polyester-8, Polyglyceryl-3 Methylglucose Distearate, Butylene Glycol, Pentylene Glycol, Steareth-21, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Sodium Hyaluronate, Octyldodecyl Olivate, Allantoin, Porphyra Umbilicalis Extract, Tocopheryl Acetate, Benzylidene Dimethoxydimethylindanone, Sea Water (Maris Aqua), Diethylhexyl Syringyldenemalonate, Polyacrylamide, Pelvetia Canaliculata Extract, Lecithin, Caprylic/Capric Triglyceride, Palmaria Palmata Extract, Ethylhexylglycerin, Algae Extract, Steareth-2, Disodium EDTA, Hydroxypropyl Starch Phosphate, Alcohol, C13-14 Isoparaffin, Sodium Lactate, Stearyl Alcohol, Dipropylene Glycol, Laureth-7, Fragrance (Parfum), Benzyl Alcohol, Phenoxyethanol, Chlorphenesin, Methylparaben, Propylparaben

  • display panel

    carton

    tube

    Sun Protection Lotion Body

    Lotion Solaire Protectrice Corps

    Sunscreen Broad Spectrum SPF 30

    La Prairie Switzerland

    180 ml/ 6.0 Fl. Oz.

    Made in Switzerland - Fabrique en Suisse

  • INGREDIENTS AND APPEARANCE
    SUN PROTECTION BODY SUNSCREEN BROAD SPECTRUM SPF 30  LA PRAIRIE
    avobenzone, homosalate, octisalate, oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68807-322
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3.0 g  in 100 kg
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.0 g  in 100 kg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 kg
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE5.0 g  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    STEARETH-21 (UNII: 53J3F32P58)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    PELVETIA CANALICULATA (UNII: 8U1M44KESN)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DULSE (UNII: 7832HOY4ZQ)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    STEARETH-2 (UNII: V56DFE46J5)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ALCOHOL (UNII: 3K9958V90M)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    LAURETH-7 (UNII: Z95S6G8201)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68807-322-1178.4 kg in 1 DRUM; Type 0: Not a Combination Product04/05/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/05/2013
    Labeler - Temmentec Ag (480586411)
    Registrant - Temmentec Ag (480586411)
    Establishment
    NameAddressID/FEIBusiness Operations
    Temmentec Ag480586411manufacture(68807-322)