Label: DERMA E MINERAL SUNSCREEN MINERAL- zinc oxide powder

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 30, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredients

    Titanium Dioxide 17.29%
    Zinc Oxide 20%

  • 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
    • Children under 6 months of age: 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
      • reapply at least every 2 hours
      • use a water resistant sunscreen if swimming or sweating
  • Other information

    • Protect this product from excessive heat and direct sun
  • Inactive Ingredients

    Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Capryloyl Glycine, Chamomilla Recutita (Matricaria) Flower Extract, Mica, Potassium Sorbate, Silica, Sodium Benzoate, Tocopherol, Undecylenoyl Glycine. May contain Iron Oxides (CI 77492, CI 77489)

  • Questions or comments?

    Call toll free 1-800-933-9344 or visit dermae.com

  • SPL UNCLASSIFIED SECTION

    Distributed by DERMA E®
    Simi Valley, CA 93065, USA

  • PRINCIPAL DISPLAY PANEL - 4 g Container Carton

    100% VEGAN • SOY-FREE
    • CRUELTY-FREE •
    SPF
    30

    DERMA • E
    ESSENTIALS

    Sun Protection
    Mineral Powder

    BROAD SPECTRUM SPF 30

    oil-free, mattifying with
    a translucent finish
    for all skin types

    • DERMATOLOGIST
    RECOMMENDED •

    0.14 OZ / 4 g

    Principal Display Panel - 4 g Container Carton
  • INGREDIENTS AND APPEARANCE
    DERMA E MINERAL SUNSCREEN   MINERAL
    zinc oxide powder
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54108-1485
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE172.9 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE200 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MICA (UNII: V8A1AW0880)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    MATRICARIA CHAMOMILLA FLOWERING TOP OIL (UNII: SA8AR2W4ER)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)  
    BROWN IRON OXIDE (UNII: 1N032N7MFO)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54108-1485-21 in 1 BOX12/01/2021
    1NDC:54108-1485-14 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35212/01/2021
    Labeler - derma e (148940450)
    Registrant - Topiderm, Inc. (049121643)
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