SUPER SENSITIVE SHIELD SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [DERMALOGICA, INC.]

SUPER SENSITIVE SHIELD SPF 30 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [DERMALOGICA, INC.]
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NDC 68479-150-00, 68479-150-01, 68479-150-02, 68479-150-04
Set ID a0d544bf-a7f7-49d9-80b5-f8eef1df392b
Category HUMAN OTC DRUG LABEL
Packager Dermalogica, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Titanium Dioxide 7.0%, Zinc Oxide 9.0%.

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

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

    Water/Aqua/Eau, Cyclopentasiloxane, Dicaprylyl Ether, Butylene Glycol, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Stearic Acid, Aluminum Hydroxide, Dimethicone, Leuconostoc/Radish Root Ferment Filtrate, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Boerhavia Diffusa Root Extract, Oxothiazolidine, Citrullus Vulgaris (Watermelon) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Sodium Hyaluronate, Sodium PCA, Sodium Lactate, Lens Esculenta (Lentil) Fruit Extract, Ascorbyl Tetraisopalmitate, Lavandula Spica (Lavender) Flower Oil, Eucalyptus Globulus Leaf Oil, Lavandula Hybrida Oil, Sodium DNA, Tocopherol, Caprylic/Capric Triglyceride, Carbomer, Pentylene Glycol, Hydroxyphenyl Propamidobenzoic Acid, Bisabolol, Zingiber Officinale (Ginger) Fruit Extract, Dimethicone/Vinyl Dimethicone Crosspolymer, Silica, Dipotassium Glycyrrhizate, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Dimethicone/ PEG-10/15 Crosspolymer, PEG/ PPG-18/18 Dimethicone, Glycerin, Cyclomethicone, Tocopheryl Acetate, Disodium EDTA, Sodium Benzoate, Sodium Chloride, Sodium Citrate, Ethylhexylglycerin, Phenoxyethanol.

  • Questions or comments

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

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    super
    sensitive
    shield

    spf
    30

    broad
    spectrum

    NPN# 80031042

    UltraCalming™

    1.7 US FL OZ
    50 mL e

    dermalogica®

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SUPER SENSITIVE SHIELD   SPF 30
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-150
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide70 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide90 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Dicaprylyl Ether (UNII: 77JZM5516Z)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone (UNII: 25G622K2RA)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Aluminum Hydroxide (UNII: 5QB0T2IUN0)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Leuconostoc/Radish Root Ferment Filtrate (UNII: D2QHA03458)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Oat (UNII: Z6J799EAJK)  
    Boerhavia Diffusa Root (UNII: KR0SR09KYL)  
    Oxothiazolidine (UNII: M6U1ZG59XD)  
    Watermelon (UNII: 231473QB6R)  
    Apple (UNII: B423VGH5S9)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Sodium Pyrrolidone Carboxylate (UNII: 469OTG57A2)  
    Sodium Lactate (UNII: TU7HW0W0QT)  
    Lens Culinaris Fruit (UNII: ZYZ076G9JH)  
    Ascorbyl Tetraisopalmitate (UNII: 47143LT58A)  
    Lavender Oil (UNII: ZBP1YXW0H8)  
    Eucalyptus Oil (UNII: 2R04ONI662)  
    Lavandin Oil (UNII: 9RES347CKG)  
    Tocopherol (UNII: R0ZB2556P8)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Carbomer Homopolymer Type C (Allyl Pentaerythritol Crosslinked) (UNII: 4Q93RCW27E)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)  
    Levomenol (UNII: 24WE03BX2T)  
    Ginger (UNII: C5529G5JPQ)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)  
    PEG/PPG-18/18 Dimethicone (UNII: 9H0AO7T794)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cyclomethicone (UNII: NMQ347994Z)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Edetate Disodium (UNII: 7FLD91C86K)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Sodium Chloride (UNII: 451W47IQ8X)  
    Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-150-021 in 1 CARTON03/05/2012
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:68479-150-013 mL in 1 BOTTLE; Type 0: Not a Combination Product03/05/2012
    3NDC:68479-150-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product03/05/2012
    4NDC:68479-150-002 mL in 1 POUCH; Type 0: Not a Combination Product03/05/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/05/2012
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosway620899877MANUFACTURE(68479-150)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-150)

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