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

  • NDC Code(s): 72812-144-01
  • 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 25%

  • 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*, Cocos nucifera (Fractionated

    Coconut) Oil*, Cera Alba (Beeswax)*, Olea 

    Europaea (Olive) Fruit Oil*, Rubus Idaeus (Red 

    Raspberry) Seed Oil*, Punica Granatum

    (Pomegranate) Seed Oil*, Simmondsia 

    Chinensis (Jojoba) Oil*, Butyrospermum Parkii

    (Shea) Butter*, Tocopherol, Calendula 

    Officinalis Flower (Calendula) Flower Extract*

    *Organic 

  • QUESTIONS

    Questions or comments? 

    503-607-0607  or earthmamaorganics.com

  • PRINCIPAL DISPLAY PANEL

    earth 

    mama

    BABY

    Mineral 

    Sunscreen Lotion 

    Broad Spectrum SPF 40

    Pediatrician Tested 

    Dermatologist tested and 

    clinically tested for irritation 

    Water Resistant (40 Minutes)

    UVA/UVB Protection 

    NSF

    contains organic ingredients 

    Contains Organic Shea Butter

    & Organic Calendula

    Non-Nano, NO Parabens, NO Artificial Fragrance 

    Net Wt 84 g (3 oz)

    SPF

    40

    Label

  • INGREDIENTS AND APPEARANCE
    EARTH MAMA BABY MINERAL SUNSCREEN SPF 40 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72812-144
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE250 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    COCONUT OIL (UNII: Q9L0O73W7L)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)  
    POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72812-144-0184 g in 1 TUBE; Type 0: Not a Combination Product04/01/2019
    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(72812-144)
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