DAILY DEFENSE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [DERMALOGICA, INC.]

DAILY DEFENSE SPF 15 (AVOBENZONE, OCTINOXATE, OCTISALATE, AND OXYBENZONE) LOTION [DERMALOGICA, INC.]
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NDC 68479-800-00, 68479-800-02
Set ID 28e4e1f8-48df-49fb-a702-d1e5b602067c
Category HUMAN OTC DRUG LABEL
Packager Dermalogica, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Avobenzone (3.0%), Octinoxate (6.5%), Octisalate (3.0%), Oxybenzone (3.5%).

  • 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 15 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.
  • Inactive ingredients

    Water/Aqua/Eau, Butylene Glycol, Caprylic/Capric Triglyceride, Glyceryl Stearate, Cetearyl Phosphate, Glycerin, Stearic Acid, Polyglyceryl-2 Stearate, Dimethicone, Lactamide MEA, Pyrus Malus (Apple) Fruit Extract, Dimethyl Capramide, Mahonia Aquifolium Root Extract, Lavandula Angustifolia (Lavender) Extract, Hydrolyzed Opuntia Ficus Indica Flower Extract, Triticum Vulgare (Wheat) Germ Extract, Saccharomyces Cerevisiae Extract, Lavandula Spica (Lavender) Flower Oil, Lavandula Hybrida Oil, Eucalyptus Globulus Leaf Oil, Sodium Hyaluronate, Dipotassium Glycyrrhizate, Palmitoyl Tripeptide-5, Sodium DNA, Tocopherol, Allantoin, Panthenol, Glycerin Crosspolymer, Ascorbyl Tetraisopalmitate, Carbomer, Polyquaternium-10, Cetyl Alcohol, Xanthan Gum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Disodium EDTA, Citric Acid, Potassium Sorbate, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerin, Hexylene Glycol.

  • Other information

    • Protect this product from excessive heat and direct sun
  • Questions or comments

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

  • PRINCIPAL DISPLAY PANEL - 100 mL Tube Carton

    daily
    defense

    spf
    15
    broad
    spectrum

    dermalogica®

    3.4 US FL OZ
    100 mL e

    Principal Display Panel - 100 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    DAILY DEFENSE   SPF 15
    avobenzone, octinoxate, octisalate, and oxybenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-800
    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) Octinoxate65 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate30 mg  in 1 mL
    Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone35 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Cetyl Phosphate (UNII: VT07D6X67O)  
    Glycerin (UNII: PDC6A3C0OX)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    N-Lactoyl Ethanolamine (UNII: 900T44YNC7)  
    Apple (UNII: B423VGH5S9)  
    Dimethyl Capramide (UNII: O29Y6X2JEZ)  
    Mahonia Aquifolium Root (UNII: 746TB9VNDP)  
    Lavandula Angustifolia Flowering Top (UNII: 9YT4B71U8P)  
    Vitis Vinifera Seed (UNII: C34U15ICXA)  
    Wheat Germ (UNII: YR3G369F5A)  
    Saccharomyces Cerevisiae (UNII: 978D8U419H)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Panthenol (UNII: WV9CM0O67Z)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)  
    Tocopherol (UNII: R0ZB2556P8)  
    Allantoin (UNII: 344S277G0Z)  
    Palmitoyl Tripeptide-5 (UNII: 2A3916MQHO)  
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Sodium NA-22 (UNII: N2511Z637B)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    Polidronium Chloride (UNII: 6716Z5YR3G)  
    Egg Phospholipids (UNII: 1Z74184RGV)  
    Aminomethylpropanol (UNII: LU49E6626Q)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Hexylene Glycol (UNII: KEH0A3F75J)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-800-021 in 1 CARTON
    1100 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-800-002 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/13/2012
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway620899877MANUFACTURE(68479-800)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-800)

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