Label: EARTH MAMA UBER-SENSITIVE MINERAL SUNSCREEN SPF 40- zinc oxide lotion

  • NDC Code(s): 72812-154-01
  • 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 September 12, 2023

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  • 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. • Temporarily protects and helps relieve minor skin irritation and itching due to: • rashes • eczema • poison ivy, oak, or sumac • insect bites. • For use on mild to moderate eczema or as directed by a physician.

  • 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. • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days.

    Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

  • Directions

    • For Eczema: Apply as needed. • 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. • Store at room temperature.

  • 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*, Simmondsia Chinensis (Jojoba) Seed Oil*, Butyrospermum Parkii (Shea) Butter*, Oryza Sativa (Rice) Bran Oil*, Tocopherol, Avena Sativa (Oat) Kernel Flour*, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Calendula Officinalis (Calendula) Flower Extract*

  • Questions or comments?

    503-607-0607 or earthmama.com

  • SPL UNCLASSIFIED SECTION

    THERAPEUTIC ECZEMA
    ITCH RELIEF

    Pediatrician & Dermatologist Tested

    Water Resistant (40 Minutes)

    Broad Spectrum
    UVA/UVB Protection

    Non-Nano / Reef-Safe

    Contains Organic Shea Butter & Colloidal Oatmeal

    NSF
    contains organic ingredients

    PLASTIC NEUTRAL

    NO Oxybenzone, Octinoxate, Artificial Preservatives or Fragrance

    FOR EVERYONE AND THEIR MOTHER.TM

    *Organic

    Distributed by Earth Mama Angel Baby® LLC
    9866 SE Empire Ct.  •  Clackamas, OR 97015 USA
    Certified to the NSF/ANSI 305 Standard by Oregon Tilth
    Awarded the National Eczema Association
    Seal of AcceptanceTM  •  Leaping Bunny Certified

  • Packaging

    SUNSCREEN LOTION-154

  • INGREDIENTS AND APPEARANCE
    EARTH MAMA UBER-SENSITIVE MINERAL SUNSCREEN SPF 40 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72812-154
    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)  
    RASPBERRY SEED OIL (UNII: 9S8867952A)  
    JOJOBA OIL (UNII: 724GKU717M)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    RICE BRAN OIL (UNII: LZO6K1506A)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    OATMEAL (UNII: 8PI54V663Y)  
    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:72812-154-0184 g in 1 TUBE; Type 0: Not a Combination Product09/12/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02009/12/2023
    Labeler - Earth Mama Angel Baby, LLC (603560686)
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