EARTH MAMA BABY MINERAL SUNSCREEN SPF 40 (ZINC OXIDE) CREAM [EARTH MAMA ANGEL BABY, LLC]

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EARTH MAMA BABY MINERAL SUNSCREEN SPF 40 (ZINC OXIDE) CREAM [EARTH MAMA ANGEL BABY, LLC]
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NDC 72812-144-01
Set ID 74475fba-4cdd-4b27-8ea4-646f4016580c
Category HUMAN OTC DRUG LABEL
Packager Earth Mama Angel Baby, LLC
Generic Name
Product Class
Product Number
Application Number PART352
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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)  
    PUNICA GRANATUM 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
    Private Label Select Ltd Co005415463manufacture(72812-144)
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