Label: ADVANCED MARINE BIOLOGY DAY SPF 20 LA PRAIRIE GROUP AG- avobenzone, octinoxate, octisalate 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

    Octinoxate 7.5% Sunscreen

    Octisalate 5.0% Sunscreen

    Uses

    • 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 children.

    Discontinue use if signs of irritation occur

    Warnings

    For External use only

    Avoid Contact with eyes

    If product gets into eyes, rinse thoroughly with water

    Directions

    • 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

    Inactive Ingredients

    Water (Aqua), Glycerin, Octyldodecyl Neopentanoate, Butyrospermum Parkii (Shea Butter), PEG-40 Stearate, Butylene Glycol, Glyceryl Stearate, Cyclopentasiloxane, Cetyl Alcohol, C12-15 Alkyl Benzoate, Hydrogenated Polyisobutene, Ammonium Acryloyldimethyltaurate/VP Copolymer, Glycoproteins*, Panax Ginseng Root Extract, Equisetum Arvense (Horsetail) Extract, Chondrus Crispus (Carrageenan) Extract, Sodium Hyaluronate, Disodium EDTA, Saccharomyces/Carrageenan Extract/Sarcodiotheca Gaudichaudii Extract Ferment, Acetyl Hexapeptide-20, Panthenol, Dimethicone, Palmaria Palmata Extract, Sodium Carbomer, Caprylic/Capric Triglyceride, Limonium Gerberi Extract, Silica, Acrylates Copolymer, Tripleurospermum Maritimum Extract, HDI/Trimethylol Hexyllactone Crosspolymer, Crambe Maritima Extract, Dipropylene Glycol Dibenzoate, Inula Crithmoide Extract, Caprylyl Glycol, Propyl Gallate, Aster Marittima/Tripolium Extract, PPG-15 Stearyl Ether Benzoate, Thalassiosira Pseudonana Extract, Carbomer, Dextran, Fragrance (Parfum), Phenoxyethanol, Sorbic Acid, Potassium Sorbate, Yellow 5 (CI 19140), Blue 1 (CI 42090)

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  • PRINCIPAL DISPLAY PANEL

    box

    bottle

    Advanced Marine Biology Day Cream

    Firms Repairs Protects

    Creme Biologie Marine Acancee Jour

    Raffermit Repare Protege

    SPF 20

    La Prairie Switzerland

    50 ml / 1.7 Fl. Oz.

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  • INGREDIENTS AND APPEARANCE
    ADVANCED MARINE BIOLOGY DAY SPF 20  LA PRAIRIE GROUP AG
    avobenzone, octinoxate, octisalate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68807-319
    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
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    PEG-40 STEARATE (UNII: ECU18C66Q7)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    CHONDRUS CRISPUS (UNII: OQS23HUA1X)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DULSE (UNII: 7832HOY4ZQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    LIMONIUM GERBERI FLOWERING TOP (UNII: V4O4C05BJ2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SORBIC ACID (UNII: X045WJ989B)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68807-319-11 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(68807-319)
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