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

Drug Label Information

Updated June 14, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • Drug Facts

  • Active Ingredient

    Zinc Oxide 25%

  • Purpose

    Sunscreen 

  • 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. 

  • 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 

  • Other Information

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

  • 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) Seed Oil*, Butyrospermum Parkii (Shea) Butter*, Tocopherol, Calendula Officinalis (Calendula) Flower Extract*

    *Organic

  • Questions or comments?

    503-607-0607 or earthmama.com

  • SPL UNCLASSIFIED SECTION

    BROAD SPECTRUM SPF 40

    Pediatrician Tested

    Dermatologist Tested & Clinically Tested for Irritation

    Water Resistant (40 Minutes)

    UVA/UVB Protection

    Non-Nano / Reef-Friendly

    Contains Organic Shea Butter & Calendula

    NSF
    contains organic ingredients

    PLASTIC NEUTRAL

    NO Oxybenzone, Octinoxate, Artificial Preservatives or Fragrance

    Gently Moisturizing Mineral Sun Protection
    FOR EVERYONE AND THEIR MOTHER.®

    Distributed by
    Earth Mama Angel Baby® LLC
    9866 SE Empire Ct.
    Clackamas, OR 97015 USA
    Certified to NSF/ANSI 305 by Oregon Tilth
    Leaping Bunny certified

  • Packaging

    EarthMama-144

  • 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 DrugM02004/01/2019
    Labeler - Earth Mama Angel Baby, LLC (603560686)