REDNESS RELIEF PRIMER SPF20 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [DERMALOGICA, INC.]

REDNESS RELIEF PRIMER SPF20 (TITANIUM DIOXIDE AND ZINC OXIDE) LOTION [DERMALOGICA, INC.]
PDF | XML

NDC 68479-009-00, 68479-009-02
Set ID f421522a-49c0-4cd7-b0c7-ce304ca3939f
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 (3.0%),
    Zinc Oxide (8.5%).

  • Purpose

    Sunscreen

  • Use

    • 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

    Cyclopentasiloxane, Isododecane, Caprylic/Capric Triglyceride, Dimethicone Crosspolymer, Caprylyl Methicone, Lauryl PEG-10 Tris (Trimethylsiloxy) Silylethyl Dimethicone, Dimethicone/Bis-Isobutyl PPG-20 Cross polymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Water/Aqua/Eau, Polyhydroxystearic Acid, Avena Sativa (Oat) Kernel Oil, Bisabolol, Saccharomyces Lysate Extract, Zingiber Officinale (Ginger) Root Extract, Boerhavia Diffusa Root Extract, Melia Azadirachta Seed Extract, Melia Azadirachta Leaf Extract, Avena Sativa (Oat) Kernel Extract, Amber Powder, Coccinia Indica Fruit Extract, Solanum Melongena (Eggplant) Fruit Extract, Ocimum Basilicum (Basil) Leaf Extract, Curcuma Longa (Tumeric) Leaf Extract, Pearl Powder, Dodecene, Hydroxyphenyl Propamidobenzoic Acid, Silica Dimethyl Silylate, Dimethicone, Butylene Glycol, Pentylene Glycol, Glycerin, Alumina, PEG-10, Stearic Acid, Triethoxycaprylylsilane, Ethylhexylglycerin, Ascorbyl Palmitate, Potassium Sorbate, Phenoxyethanol, Iron Oxides CI 77492, CI 77499.

  • Questions or comments?

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

  • PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton

    redness
    relief
    primer

    spf
    20

    broad
    spectrum

    UVA medium protection

    UltraCalming

    0.75 US FL OZ / 22 mL e

    dermalogica®

    PRINCIPAL DISPLAY PANEL - 22 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    REDNESS RELIEF PRIMER   SPF20
    titanium dioxide and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide30 mg  in 1 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide85 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Isododecane (UNII: A8289P68Y2)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Caprylyl Trisiloxane (UNII: Q95M2P1KJL)  
    Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer (UNII: O4I3UFO6ZF)  
    Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)  
    Water (UNII: 059QF0KO0R)  
    Polyhydroxystearic Acid (2300 MW) (UNII: YXH47AOU0F)  
    Oat Kernel Oil (UNII: 3UVP41R77R)  
    Levomenol (UNII: 24WE03BX2T)  
    Saccharomyces Lysate (UNII: R85W246Z1C)  
    Ginger (UNII: C5529G5JPQ)  
    Boerhavia Diffusa Root (UNII: KR0SR09KYL)  
    Azadirachta Indica Seed (UNII: P1NV46V59R)  
    Azadirachta Indica Leaf (UNII: HKY915780T)  
    Oat (UNII: Z6J799EAJK)  
    Amber (UNII: 70J9Z0J26P)  
    Coccinia Grandis Fruit (UNII: VLJ6WOT3K5)  
    Eggplant (UNII: W5K7RAS4VK)  
    Basil (UNII: 2U0KZP0FDW)  
    Curcuma Longa Leaf (UNII: H2HC4RY52C)  
    Pearl (Hyriopsis Cumingii) (UNII: A75L5FZ40U)  
    Dodecene (UNII: WYE669F3GR)  
    Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)  
    Silica Dimethyl Silylate (UNII: EU2PSP0G0W)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Pentylene Glycol (UNII: 50C1307PZG)  
    Glycerin (UNII: PDC6A3C0OX)  
    Aluminum Oxide (UNII: LMI26O6933)  
    POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ferric Oxide Yellow (UNII: EX438O2MRT)  
    Ferrosoferric Oxide (UNII: XM0M87F357)  
    Product Characteristics
    ColorGREENScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68479-009-021 in 1 CARTON
    122 mL in 1 TUBE; Type 0: Not a Combination Product
    2NDC:68479-009-002 mL in 1 POUCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35203/21/2014
    Labeler - Dermalogica, Inc. (177698560)
    Establishment
    NameAddressID/FEIBusiness Operations
    PakLab790530976MANUFACTURE(68479-009)
    Establishment
    NameAddressID/FEIBusiness Operations
    Diamond Wipes161104729MANUFACTURE(68479-009)

Related Drugs