Label: LINE INTERCEPTION POWER DUO DAY CREAM SUNCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene cream

  • NDC Code(s): 68807-326-11, 68807-326-22, 68807-326-33
  • Packager: Temmentec AG
  • 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 5, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredients                     Purpose

    Avobenzone 2.7% .............

    Homosalate 9.0% .............   Sunscreen

    Octisalate   4.5% ............

    Octocrylene 9.0% ...........

  • PURPOSE

    Helps prevent sunburn

  • KEEP OUT OF REACH OF CHILDREN

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

  • INDICATIONS & USAGE

    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

  • DOSAGE & ADMINISTRATION

    Directions

    • apply daily after cleansing and toning
    • smooth over face & throat
    • apply liberally 15 minutes before sun exposure
    • children und 6 months of age: Ask a doctor
    • reapply at least every 2 hours
    • use a water resistan sunscreen if swimming or sweating
    • Sun Protection Measures. Spending time in the sunincreases 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 oher 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 INGREDIENT

    Inactive Ingredients:

    Water (Aqua), Glycerin, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Butylene Glycol, Microcrystalline Cellulose, Polymethylsilsquioxane, Glycoproteins, Panax Ginseng Root Extract, Equisetum Arvense Extract, Carnosine, Lactic Acid, Glycolic Acid, Palmitoyl Hexapeptide-52, Palmitoyl Heptapeptide-18, Dipeptide Diaminobutyroyl Benzylamide Diacetate, Urea, Sodium Stearoyl Lactylate, Saccharide Hydrolysate, Alanine, Glycine, Magnesium Aspartate, Creatine, Pinus Pinaster Bark/Bud Extract, Diglycerin, Ascorbic Acid, Lauryl Lactate, Tocopherol, Lactobaillus Ferment, Diethylhexyl Syringylidenemalonate, Saccharomyces Cerevisiae Extract, Ascorbyl Palmitate, Disodium EDTA, Behenyl Alcohol, C20-22 Alcohol, Sodium Hydroxide, Citric Acid, Dimethicone, Caprylic/Capric Triglyceride, PEG-8, Isodecyl Neopentanoate, Polyglyceryl-10 Pentastearate, Diisopropyl Sebacate, Ethylhexylglycerin, C20-22 Alkyl Phosphate, Steareth-21, Cellulose Gum, Polyvinyl Alcohol, Xanthan Gum, Fragrance (Parfum) Linalool, Citronellol, Hydroxycitronellal, Hexyl Cinnamal, Benzyl Benzoate, Butylphenyl Methylpropional, Evernia Furfuracea (Treemoss) Extract, Phenoxyethanol, Potassium Sorbate, Sodium Dehydroacetate, Dehydroacetic Acid, Reg 4 (CI 14700), Yellow 5 (CI 19140)

  • PRINCIPAL DISPLAY PANEL

    La Prairie

    Line Interception Anti-Wrinkle Day - Night Intervention

    Day Cream

    Sunscreen

    Broad Spectrum

    SPF30


    50 ml e / 1.7 FL. OZ.

    Carton

  • INGREDIENTS AND APPEARANCE
    LINE INTERCEPTION POWER DUO DAY CREAM SUNCREEN  BROAD SPECTRUM SPF 30
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68807-326
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.7 g  in 100 kg
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9.0 g  in 100 kg
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 g  in 100 kg
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9.0 g  in 100 kg
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    GLYCOPROTEIN HORMONES ALPHA CHAIN (UNII: 8YJ68CQ409)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    EQUISETUM ARVENSE BRANCH (UNII: 1L0VKZ185E)  
    CARNOSINE (UNII: 8HO6PVN24W)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    GLYCOLIC ACID (UNII: 0WT12SX38S)  
    DIPEPTIDE DIAMINOBUTYROYL BENZYLAMIDE DIACETATE (UNII: 38H206R00R)  
    UREA (UNII: 8W8T17847W)  
    SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
    INVERT SUGAR (UNII: ED959S6ACY)  
    ALANINE (UNII: OF5P57N2ZX)  
    GLYCINE (UNII: TE7660XO1C)  
    MAGNESIUM ASPARTATE (UNII: R17X820ROL)  
    CREATINE (UNII: MU72812GK0)  
    DIGLYCERIN (UNII: 3YC120743U)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    LAURYL LACTATE (UNII: G5SU0BFK7O)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    LACTOBACILLUS REUTERI (UNII: 9913I24QEE)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    C20-22 ALKYL PHOSPHATE (UNII: L4VKP0Y7RP)  
    STEARETH-21 (UNII: 53J3F32P58)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    POLYVINYL ALCOHOL (UNII: 532B59J990)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR)  
    .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    GERANIOL (UNII: L837108USY)  
    BENZYL BENZOATE (UNII: N863NB338G)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    PSEUDEVERNIA FURFURACEA (UNII: 49ZMN09Q0K)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68807-326-1160 kg in 1 DRUM; Type 0: Not a Combination Product04/14/2016
    2NDC:68807-326-22120 kg in 1 DRUM; Type 0: Not a Combination Product04/14/2016
    3NDC:68807-326-3378.4 kg in 1 DRUM; Type 0: Not a Combination Product04/14/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/14/2016
    Labeler - Temmentec AG (480586411)
    Registrant - Temmentec AG (480586411)
    Establishment
    NameAddressID/FEIBusiness Operations
    Temmentec AG480586411manufacture(68807-326)