Label: EARTH MAMA BABY FACE MINERAL SUNSCREEN SPF 40- zinc oxide cream

  • NDC Code(s): 72812-143-01
  • 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

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  • Drug Facts 

    Active Ingredient 

    Zinc Oxide 22%

  • PURPOSE

    Purpose 

    Sunscreen 

  • INDICATIONS & USAGE

    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. 
  • 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. 

  • DOSAGE & ADMINISTRATION

    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 10 a.m. - 2 p.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 

  • STORAGE AND HANDLING

    Other Information 

    • Protect the product in this container from exessive heat and direct sun. 
  • INACTIVE INGREDIENT

    Inactive Ingredients Cocos

    Nucifera (Coconut) Oil*, Helianthus Annuus

    (Sunflower) Seed Oil*, Beeswax (Cera 

    Alba) (Cire d'abeille)*, Euphorbia Cerifera

    Cera (Candelilla Wax), Copernicia Cerifera 

    (Carnauba) Wax*, Bulyrospermum Parkii

    (Shea) Butter*, Tocopherol, Theobroma

    Cacao (Cocoa) Seed Butter*, Aloe

    Barbadensis Leaf Juice*, Calendula 

    Officinalis Flower Extract*

    *Organic 

  • QUESTIONS

    Questions or comments? 

    503-607-0607  or earthmamaorganics.com

  • PRINCIPAL DISPLAY PANEL

    earth 

    mama 

    BABY 

    Baby Face 

    Mineral 

    Sunscreen

    NSF

    contains organic

    ingredients 

    Non-Nano, NO Parabens,

    NO Artificial Fragrance 

    Broad Spectrum 

    SPF 40 

    FACE STICK 


    Net Wt 21 g (.74 oz)

    Baby Face Carton

    Baby Face Label

  • INGREDIENTS AND APPEARANCE
    EARTH MAMA BABY FACE MINERAL SUNSCREEN SPF 40 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72812-143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE220 mg  in 1 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)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72812-143-011 in 1 PACKAGE04/01/2019
    121 g in 1 APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/01/2019
    Labeler - Earth Mama Angel Baby, LLC (603560686)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Solutions, LLC807907928manufacture(72812-143)
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