Label: EARTH MAMA LADY FACE MINERAL SUNSCREEN - LIGHT/MEDIUM TINT BROAD SPECTRUM SPF 40- zinc oxide stick

  • NDC Code(s): 72812-149-01
  • Packager: Earth Mama Angel Baby LLC
  • 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 August 30, 2023

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Zinc Oxide 22%

  • Purpose

    Sunscreen

  • 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 Poison Control Center right away.

  • Uses


    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases risk of skin cancer and early skin aging caused by the sun.

  • Directions

    Apply generously and evenly to all skin exposed to sun 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures, including:

    • limit time in the sun, especially from 10a.m. to 2p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses

    Reapply

    • after 40 minutes of swimming or sweating
    •  immediately after towel drying
    • at least every 2 hours
  • Other Information

    • Protect the product in this container from excessive heat and direct sun

  • Questions or Comments? 503-607-0607 or EarthMama.com

  • Inactive Ingredients

    Cocos Nucifera (Coconut) Oil*, Helianthus Annuus (Sunflower) Seed
    Oil*, Beeswax*, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba)
    Wax*, Butyrospermum Parkii (Shea) Butter*, Tocopherol, Theobroma Cacao (Cocoa)
    Seed Butter*, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Calendula Officinalis (Calendula)
    Flower Extract*, Titanium Dioxide, Iron Oxides.

    *Organic

  • PRINCIPAL DISPLAY PANEL

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  • Outer carton

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  • INGREDIENTS AND APPEARANCE
    EARTH MAMA LADY FACE MINERAL SUNSCREEN - LIGHT/MEDIUM TINT BROAD SPECTRUM SPF 40 
    zinc oxide stick
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72812-149
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    COCOA BUTTER (UNII: 512OYT1CRR)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72812-149-011 in 1 CARTON06/08/2020
    121 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35206/05/2020
    Labeler - Earth Mama Angel Baby LLC (603560686)