Label: MADE OF BROAD SPECTRUM SPF 30 NON-NANO ZINC OXIDE SUNSCREEN- zinc oxide lotion

  • 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 17, 2020

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    Non-Nano Uncoated Zinc Oxide 20.0%

  • 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.

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • Directions

    • Diretions for full protection, apply liberally (2mg/cm2) to all exposed skin 15 minutes before sun exposure then rub it in to reduce whitening effect.

    Reapply:

    • After 40 minutes of swimming or sweating • Immediately after towel drying. • At least every two hours.

    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 value of 15 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10am-2pm
      • Wear long-sleeved shirts, pants, hats, and sunglasses
    • For children under six months of age ask a doctor.
  • Ingredients

    Helianthus Annuus* (Sunflower) Oil, Cocos Nucifera* (Coconut) Oil, Cera Alba* (Beeswax), Theobroma Cacao* (Cocoa) Seed Butter, Vanilla Oil* (Vanilla), Tocopherol*, Argania Spinosa Leaf* (Argan) Oil, Rubus Ideaus* (Raspberry) Seed Oil
    *=Certified Organic

  • Other information:

    Store at temperatures below 90°F

  • PRINCIPAL DISPLAY PANEL - 118 ml Tube

    made of ®
    Broad Spectrum Sunscreen

    SPF 30
    Water Resistant (80 minutes)

    79% Certified Organic Ingredients

    21% Natural

    NSF

    Non GMO

    Soy Free

    Nut Free

    Pediatrician Tested

    Dermatologist Tested

    4 fl.oz (118 ml)

    Sunscreen box

    Sunscreen Label

  • INGREDIENTS AND APPEARANCE
    MADE OF BROAD SPECTRUM SPF 30 NON-NANO ZINC OXIDE SUNSCREEN 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71439-050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    VANILLA PLANIFOLIA OIL (UNII: 0A3F415158)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71439-050-161 in 1 CARTON09/05/2017
    1118 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35209/05/2017
    Labeler - MADEOF, LLC (080635957)
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