Label: ETADERM TATTOO SUNSCREEN BROAD SPECTRUM SPF-30- zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated March 20, 2024

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  • Drug Facts

  • Active Ingredients

    Zinc Oxide 15.00%

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sun burn. 
    • higher SPF gives more sun burn protection
    • 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 or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding, 

    ask a health professional before use

  • Directions:

    • Apply liberally15 minutes before sun exposure and as needed.
    • Children under 6 months of age: ask a doctor.
    • Reapply: at least every 2 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 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-sleeved shirts, pants, hats, and sunglasses.
  • Other Information:

    • Protect the product in this container from excessive heat and direct sun.
  • Inactive Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Ascorbic Acid (Vitamin E), Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Calendula Officinalis Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Cucumis Sativus (Cucumber) Extract, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sun flower) Oil, Hydrolyzed Collagen, Polyhydroxy stearic Acid, Polysorbate 20, Rosa Canina (Rose) Hips Oil, Sorbitan Olivate, Theobroma Cacao (Cocoa)Butter, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Zemea (Corn) Propanediol

  • Questions?

    Please visit our website, www.etaderm.com

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    ETADERM TATTOO SUNSCREEN BROAD SPECTRUM SPF-30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84180-472
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION150 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    CUCUMBER (UNII: YY7C30VXJT)  
    CARROT (UNII: L56Z1JK48B)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    COCOA (UNII: D9108TZ9KG)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84180-472-00118 mL in 1 BOTTLE; Type 0: Not a Combination Product04/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/01/2024
    Labeler - NUEPHASE LLC (118900101)