Label: NUDIST LIP BUTTER NATURAL- zinc oxide stick

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 June 23, 2020

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  • Active Ingredient

    Zinc Oxide 5%

  • Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.

  • Warnings

    • For external use only.
    • Do not use on damaged or broken skin.
    • Stop use and ask doctor if skin rash occurs.
    • 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 Poison Control Center right away.
  • Directions

    Apply liberally to the lips. 

    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 a Broad

    Spectrum SPF value 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

  • Inactive Ingredients

    Castor Isostearate Succinate, Acacia Decurrens/Jojoba/Sunflower Seed Wax/Polyglyceryl-Esters, Tribehenin, Oleic/Linoleic/Lonolenic
    Polyglycarides, Euphorbia Cerifera (Candelila) Wax*, Simmondsia Chinensis (Jojoba) Oil*, Helianthus Annuus (Sunflower) Seed Oil*,
    Rubus Idaeus (Red Raspberry) Seed Oil*, Daucus Carota Sativa (Carrot) Seed Oil*, Mixed Tocopherols, Camellia Sinensis Leaf Extract*,
    Mentha Spicata (Spearmint)*, Vanilla Planifolia Fruit*. [± Iron Oxide (CI 77491, 77492, 77499), D & C Red 33 (CI 17200), D&C Red No. (CI
    15850), Manganese Violet (CI 77742), Mica (CI 77019)

    *ORGANIC INGREDIENTS

  • Other Information

    Protect this product from excessive heat and direct sun. This is a water reisstant product.

  • Questions?

    www.W3LLPEOPLE.com

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    NUDIST LIP BUTTER NATURAL 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73621-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SUCCINIC ACID (UNII: AB6MNQ6J6L)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    CARROT SEED OIL (UNII: 595AO13F11)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MENTHA SPICATA OIL (UNII: C3M81465G5)  
    VANILLA BEAN (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73621-001-011 in 1 CARTON02/14/2020
    12 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35202/14/2020
    Labeler - W3LL PEOPLE INC (079693803)
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