Label: SUN PROTECTION EMULSION FACE- 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 February 14, 2011

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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


    - Helps prevent sunburn

    - for skin that burns easily

    -provides moderate protection against sunburn

    -higher SPF gives more sunburn protection

    Keep out of reach of children.

    Do not use on infants under 6 months of age.

    Stop use and ask a doctor if rash or irritation develops and lasts.

    when using this product keep out of eyes.

    rinse with water to remove.

    Apply daily after cleansing and toning .

    Smooth over face and throat.

    Apply evenly before sun exposure.

    Reapply as needed or after towel drying, swimming or perspiring.

    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 Hyaluronate, Corallina Officinalis Extract, Sea Water ( Maris Aqua), Algae Extract, Aloe Barbadensis Leaf Juice, Steareth-2, Ethylhexyl Glycerin, Disodium EDTA, Benzylidene Dimethoxydimethylindanone, sodium hydroxide, porphyra Umbilicalis Extract, Squalane, Carbomer, Potassium Sorbate, Hydroxyethyl acrylate/ Sodium Acryloyldimethyl Taurate Copolymer, Palmaria Pakmata 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, Propyparaben





    image of back label

  • PRINCIPAL DISPLAY PANEL

    Sun protection emulsion face SPF 30


    125mL/ 4.2 FL. OZ.


    image of front label

  • INGREDIENTS AND APPEARANCE
    SUN PROTECTION EMULSION FACE   LA PRAIRIE
    avobenzone, homosalate, octisalate, octocrylene, oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59614-221
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone3 mL  in 100 mL
    Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate10 mL  in 100 mL
    Octisalate (UNII: 4X49Y0596W) (octisalate - UNII:4X49Y0596W) Octisalate 2.5 mL  in 100 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.4 mL  in 100 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Hexyldecanol (UNII: 151Z7P1317)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARETH-2 (UNII: V56DFE46J5)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    squalane (UNII: GW89575KF9)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    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:59614-221-110.088 mL in 1 DRUM
    2NDC:59614-221-021 in 1 BOX
    2NDC:59614-221-01125 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/14/2011
    Labeler - Juvena GMBH (315053785)
    Registrant - Juvena GMBH (315053785)
    Establishment
    NameAddressID/FEIBusiness Operations
    Temmentec Ag480586411manufacture
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