ULTRA PROTECTION STICK BROAD SPECTRUM SPF 40 LA PRAIRIE SWITZERLAND (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE) STICK [TEMMENTEC AG]

ULTRA PROTECTION STICK BROAD SPECTRUM SPF 40 LA PRAIRIE SWITZERLAND (AVOBENZONE, HOMOSALATE, OCTISALATE, OXYBENZONE) STICK [TEMMENTEC AG]
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NDC 68807-309-01, 68807-309-02
Set ID 99ca4a08-bae6-420f-8b6d-e9606622ef82
Category HUMAN OTC DRUG LABEL
Packager Temmentec Ag
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients      Purpose

    Avobenzone 3%       Sunscreen

    Homosalate 7%        Sunscreen

    Octisalate 5%           Sunscreen

    Oxybenzone 2%       Sunscreen

    Uses

    helps prevent sunburn

    warning

    Keep out of reach of children

    Indications

    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

     apply liberally 15 minutes befor e 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

    Polyethylene, Petrolatum, C12-15 Alkyl Benzoate, Caprylyl Methicone, Aluminum Starch Octenylsuccinate, Butyloctyl Salicylate, Polyester-8, Simmondsia Chinensis (Jojoba) Butter, Water (Aqua), ButyrospermumParkii (Shea Butter), Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Beeswax (Cera Alba), VP/Eicosene Copolymer, Pelvetia Canaliculata Extract, Sodium Lactate, Palmaria Palmata Extract, Behenyl Olivate, Lecithin, Porphyra Umbilicalis Extract, Ammonium Glycyrrhizate, Algae Extract, Benzylidene Dimethoxydimethylindanone, Dipropylene Glycol, BHT, Alcohol, Butylene Glycol, Phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    carton

    stick

    Ultra Protection Stick

    Eye - Lip -  Nose

    Sunscreen Broad Spectrum


    Stick Solaire Haute Protection

    Yeux - Levres - Nez

    Creme Solaire

    Large Spectre

    SPF 40

    la prarie Switzerland

    10 g/ Net Wt. 0.35 OZ

    Made in Switzerland Fabrique en Suisse

  • INGREDIENTS AND APPEARANCE
    ULTRA PROTECTION STICK BROAD SPECTRUM SPF 40  LA PRAIRIE SWITZERLAND
    avobenzone, homosalate, octisalate, oxybenzone stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68807-309
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7 g  in 100 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYETHYLENE GLYCOL 350 (UNII: ZBR3T82M2V)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)  
    JOJOBA BUTTER (UNII: XIA46H803R)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    PELVETIA CANALICULATA (UNII: 8U1M44KESN)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    DULSE (UNII: 7832HOY4ZQ)  
    BEHENYL OLIVATE (UNII: NGS1GGK4GW)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)  
    AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)  
    BENZYLIDENE DIMETHOXYDIMETHYLINDANONE (UNII: 75HIF3C97L)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68807-309-021 in 1 BOX
    1NDC:68807-309-0110 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/04/2013
    Labeler - Temmentec Ag (480586411)
    Registrant - Temmentec Ag (480586411)
    Establishment
    NameAddressID/FEIBusiness Operations
    Temmentec Ag480586411manufacture(68807-309)

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