Label: PURELIGHT SPF50- avobenzone and octinoxate 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 December 11, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Avobenzone (3.0%)

    Octinoxate (7.5%)

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • If used as directed with other sun protection measures (see Directions), helps decrease the risk of skin cancer and early skin aging caused by the sun.
  • 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.

    Stop use and ask a doctor

    • if rash occurs.

    Keep out of reach of children.

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Apply liberally 30 minutes before sun exposure
    • Reapply at least every two 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 help decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF 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
    • Do not use on infants under 6 months old.
  • Other information

    • Protect this product from excessive heat and direct sun.
  • Inactive ingredients

    Water/Aqua/Eau, Carthamus Tinctorius (Safflower) Oleosomes, Butylene Glycol, Glycerin, C12-15 Alkyl Benzoate, Polysorbate 80, Dimethyl Capramide, Sodium Hyaluronate Crosspolymer, Cananga Odorata Flower Oil, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Oil, Lavendula Spica (Lavender) Flower Oil, Laminaria Ochroleuca Extract, Palmaria Palmata Extract, Oligopeptide-34, Dipotassium Glycyrrhizate, Lactobacillus/Pumpkin Fruit Ferment Filtrate, Niacinamide, Zinc Glycinate, Polysorbate 60, Ammonium Acryloyldimethyltaurate/VP Copolymer, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isohexadecane, Butylene Glycol Behenate, Glyceryl Polyacrylate, Disodium EDTA, Sodium Hydroxide, Ethylhexylglycerin, Phenoxyethanol.

  • Questions or comments?

    Call toll free 1-800-831-5150 in the US.

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

    pure
    light

    spf
    50
    broad
    spectrum

    UVA high protection

    PowerBright TRx™

    1.7 US FL OZ / 50 mL e

    dermalogica®

    Principal Display Panel - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    PURELIGHT   SPF50
    avobenzone and octinoxate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-213
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone30 mg  in 1 mL
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate75 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Carthamus Tinctorius Seed Oleosomes (UNII: 9S60Q72309)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Glycerin (UNII: PDC6A3C0OX)  
    Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
    Polysorbate 80 (UNII: 6OZP39ZG8H)  
    Dimethyl Capramide (UNII: O29Y6X2JEZ)  
    Cananga Oil (UNII: 8YOY78GNNX)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Laminaria Ochroleuca (UNII: 4R2124HE76)  
    Dulse (UNII: 7832HOY4ZQ)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Niacinamide (UNII: 25X51I8RD4)  
    Zinc Glycinate (UNII: 681VJX72FE)  
    Polysorbate 60 (UNII: CAL22UVI4M)  
    Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)  
    Isohexadecane (UNII: 918X1OUF1E)  
    Butylene Glycol Behenate (UNII: X0IW5BP6ZL)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-213-021 in 1 CARTON02/18/2014
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-213-002 mL in 1 POUCH; Type 0: Not a Combination Product02/18/2014
    3NDC:68479-213-0110 mL in 1 TUBE; Type 0: Not a Combination Product02/18/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35202/18/2014
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    THIBIANT083913913MANUFACTURE(68479-213)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-213)
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