Label: INVISIBLE PHYSICAL DEFENSE SPF 30- zinc oxide 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 March 5, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Zinc Oxide (20%)

  • 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.
    • Children under 6 months: ask a doctor.
  • Other information

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

    Water/Aqua/Eau, Caprylic/Capric Triglyceride, C12-15 Alkyl Benzoate, Dimethicone, Butyloctyl Salicylate, Butylene Glycol, Glycerin, Silica, Polyhydroxystearic Acid, PEG-10 Dimethicone, Argania Spinosa Kernel Oil, Cordyceps Sinensis Extract, Trametes Versicolor Extract, Sodium Hyaluronate, Camellia Sinensis Leaf Extract, Eucalyptus Globulus Leaf Oil, Lavandula Spica (Lavender) Flower Oil, Tocopheryl Acetate, Sodium Chloride, Stearalkonium Hectorite, Pentylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Propanediol, Dimethicone Crosspolymer, Sodium Citrate, Propylene Carbonate, Xanthan Gum, Caprylyl Glycol, Bisabolol, Lavandula Hybrida Oil, Ethylhexylglycerin, Sodium Hydroxide, Potassium Sorbate, Sodium Benzoate.

  • Questions or comments

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

  • PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

    invisible
    physical
    defense

    dermalogica

    SPF
    30

    broad spectrum

    weightless
    physical
    sunscreen

    1.7 US FL OZ / 50 mL ℮

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    INVISIBLE PHYSICAL DEFENSE SPF 30 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-909
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide200 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Glycerin (UNII: PDC6A3C0OX)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    OPHIOCORDYCEPS SINENSIS (UNII: 8Q1GYP08KU)  
    TRAMETES VERSICOLOR FRUITING BODY (UNII: 4C900477MT)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Stearalkonium Hectorite (UNII: OLX698AH5P)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)  
    Propanediol (UNII: 5965N8W85T)  
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    Propylene Carbonate (UNII: 8D08K3S51E)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    LAVANDIN OIL (UNII: 9RES347CKG)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-909-011 in 1 CARTON03/05/2020
    17 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-909-0250 mL in 1 TUBE; Type 0: Not a Combination Product03/05/2020
    3NDC:68479-909-04177 mL in 1 TUBE; Type 0: Not a Combination Product03/05/2020
    4NDC:68479-909-00177 mL in 1 TUBE; Type 0: Not a Combination Product03/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/05/2020
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    McKenna090631412MANUFACTURE(68479-909)
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