EVENLY RADIANT BRIGHTENING DAY CREME SPF 15 (OCTINOXATE AND ZINC OXIDE) CREAM [DERMA E]

EVENLY RADIANT BRIGHTENING DAY CREME SPF 15 (OCTINOXATE AND ZINC OXIDE) CREAM [DERMA E]
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NDC 54108-0333-0
Set ID d4f2b068-2f7b-4ce1-b576-139a788de8df
Category HUMAN OTC DRUG LABEL
Packager derma e
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Octinoxate 5.5%, Zinc Oxide 5.5%

  • Purpose

    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 a 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

    • apply liberally 15 minutes before sun exposure
    • use a water resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
    • children under 6 months: Ask a doctor
    • 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 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
  • Inactive ingredients

    Purified Water (Aqua), Cetearyl Olivate, Sorbitan Olivate, Propanediol, Glycerin, Carthamus Tinctorius (Safflower) Seed Oil, Niacinamide (Vitamin B3), Capric/Caprylic Triglyceride, Cetyl Alcohol, Glyceryl Stearate Citrate, Arctostaphylos Uva Ursi (Bearberry) Leaf Extract, Ascorbyl Palmitate (C-Ester), Lilium Candidum (Madonna Lily) Leaf Cell Extract, Glycyrrhiza Glabra (Licorice) Root Extract, Tocopheryl Acetate (Vitamin E), Panthenol (Provitamin B5), Vitis Vinifera (Grape) Seed Oil, Epilobium Angustifolium (Canadian Willowherb™) Extract, Organic Camellia Sinensis (Green Tea) Leaf Extract1 (.1%), Organic Olea Europaea (Olive) Fruit Oil1 (.1%), Glyceryl Stearate, Polysorbate 20, Potassium Sorbate, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin.


    1
    Certified Organic by Quality Assurance International or USDA.
  • Other information

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

    Call toll free 1-800-933-9344

  • SPL UNCLASSIFIED SECTION

    Distributed by derma e®
    Simi Valley, CA 93063, USA

  • PRINCIPAL DISPLAY PANEL - 56 g Jar Box

    all
    dry
    normal
    oily

    • CRUELTY-FREE • PARABEN-FREE •
    natural
    100% VEGAN

    derma e®

    Evenly Radiant®
    Brightening
    Day Crème SPF 15
    With Vitamin C

    net wt 2 oz / 56 g e • Broad Spectrum SPF 15 Sunscreen

    Principal Display Panel - 56 g Jar Box
  • INGREDIENTS AND APPEARANCE
    EVENLY RADIANT BRIGHTENING DAY CREME SPF 15 
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54108-0333
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate55 mg  in 1 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide55 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Propanediol (UNII: 5965N8W85T)  
    Glycerin (UNII: PDC6A3C0OX)  
    Safflower Oil (UNII: 65UEH262IS)  
    Niacinamide (UNII: 25X51I8RD4)  
    Tricaprylin (UNII: 6P92858988)  
    Cetyl Alcohol (UNII: 936JST6JCN)  
    Glyceryl Stearate Citrate (UNII: WH8T92A065)  
    Cetearyl Olivate (UNII: 58B69Q84JO)  
    Sorbitan Olivate (UNII: MDL271E3GR)  
    Arctostaphylos Uva-Ursi Leaf (UNII: 3M5V3D1X36)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Lilium Candidum Bulb (UNII: AHG15J8AM0)  
    Glycyrrhiza Glabra (UNII: 2788Z9758H)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Panthenol (UNII: WV9CM0O67Z)  
    Grape Seed Oil (UNII: 930MLC8XGG)  
    Epilobium Angustifolium Leaf (UNII: 7NV86426N2)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Olive Oil (UNII: 6UYK2W1W1E)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Polysorbate 20 (UNII: 7T1F30V5YH)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54108-0333-01 in 1 BOX
    156 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35204/17/2014
    Labeler - derma e (148940450)

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