DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [AVEDA COPORATION]

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DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [AVEDA COPORATION]
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NDC 57677-063-01
Set ID dfa84bcc-a9b4-426d-8733-35f58c40e94d
Category HUMAN OTC DRUG LABEL
Packager Aveda Corporation
Generic Name
Product Class
Product Number
Application Number PART352
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Titanium dioxide 6.3%Sunscreen
    Zinc oxide 4.1%Sunscreen
  • Uses

    • helps prevent sunburn
    • if used as directed with other sun protection measures (see Directions), decreases 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 doctor if rash occurs.

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

  • Directions

    • shake well. apply generously 15 minutes before sun exposure
    • for sunscreen use, 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 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
    • children under 6 months of age: ask a doctor
  • Inactive ingredients

    Water\Aqua\Eau, Dimethicone, Dicaprylyl Carbonate, Butyloctyl Salicylate, Coco-Caprylate/Caprate, Propanediol, Dipentaerythrityl Tri-Polyhydroxystearate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Aleurites Moluccana (Kukui) Seed Oil, Trimethylsiloxysilicate, Silica, Hydrogenated Castor Oil/Sebacic Acid Copolymer, Rosmarinus Officinalis (Rosemary) Extract, Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Caffeine, Punica Granatum (Pomegranate) Extract, Polygonum Cuspidatum, Root Extract, Zingiber Officinale (Ginger) Root Extract, Vanilla Planifolia Fruit Extract, Oryzanol, Ascorbyl Palmitate, Hydroxyapatite, Dimethicone Silylate, Triethoxycaprylylsilane, Dimethicone Crosspolymer-3, Dimethicone/Polyglycerin-3 Crosspolymer, Cetyl PEG/PPG-10/1 Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Caprylyl Glycol, Phenoxyethanol <ILN41846>

  • Other Information

    Protect the product in this container from excessive heat and direct sun.

  • PRINCIPAL DISPLAY PANEL - 30 ml Bottle Carton

    AVEDA
    THE ART AND SCIENCE OF PURE
    FLOWER AND PLANT ESSENCES

    daily light
    guard™

    defense fluid
    broad spectrum
    SPF 30

    1 fl oz/oz liq/30 ml e

    Principal Display Panel - 30 ml Bottle Carton
  • INGREDIENTS AND APPEARANCE
    DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30 
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57677-063
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE65.85 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE42.85 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ROSEMARY (UNII: IJ67X351P9)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAFFEINE (UNII: 3G6A5W338E)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    REYNOUTRIA JAPONICA ROOT (UNII: 7TRV45YZF7)  
    GINGER (UNII: C5529G5JPQ)  
    VANILLA BEAN (UNII: Q74T35078H)  
    ORYZANOL (UNII: SST9XCL51M)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57677-063-011 in 1 CARTON05/01/2016
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35205/01/2016
    Labeler - Aveda Corporation (071352058)
    Registrant - Estee Lauder Companies Inc. (790802086)
    Establishment
    NameAddressID/FEIBusiness Operations
    Whitman Laboratories Ltd.216866277MANUFACTURE(57677-063) , REPACK(57677-063) , RELABEL(57677-063)
    Establishment
    NameAddressID/FEIBusiness Operations
    ESTEE LAUDER COMPANY, THE828534516REPACK(57677-063) , RELABEL(57677-063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.202952982MANUFACTURE(57677-063) , REPACK(57677-063) , RELABEL(57677-063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder Cosmetics Ltd.204132062RELABEL(57677-063) , REPACK(57677-063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Estee Lauder N.V.370151326MANUFACTURE(57677-063) , REPACK(57677-063) , RELABEL(57677-063)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC INC943871157REPACK(57677-063) , RELABEL(57677-063)
    Establishment
    NameAddressID/FEIBusiness Operations
    NORTHTEC PALC102631997REPACK(57677-063) , RELABEL(57677-063)
    Establishment
    NameAddressID/FEIBusiness Operations
    PADC 1949264774REPACK(57677-063) , RELABEL(57677-063)
    Establishment
    NameAddressID/FEIBusiness Operations
    Len-Ron Manufacturing Division of Aramis Inc.809771152MANUFACTURE(57677-063) , REPACK(57677-063) , RELABEL(57677-063)
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