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  5. Label Information: Earth Mama Baby Mineral Sunscreen Spf 40

FDA Label for Earth Mama Baby Mineral Sunscreen Spf 40

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DOSAGE & ADMINISTRATION
    10. STORAGE AND HANDLING
    11. INACTIVE INGREDIENT
    12. OTC - QUESTIONS
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Earth Mama Baby Mineral Sunscreen Spf 40 Product Label

The following document was submitted to the FDA by the labeler of this product Earth Mama Angel Baby, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Drug Facts



Active Ingredient 

Zinc Oxide 25%


Otc - 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


Otc - Do Not Use



Do not use 

  • on damaged or broken skin.

Otc - When Using



When using this product 

  • keep out of eyes. Rinse with water to remove. 

Otc - Stop Use



Stop use and ask a doctor if 

  • rash occurs 

Otc - Keep Out Of Reach Of Children



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 


Otc - Questions



Questions or comments? 

503-607-0607  or earthmamaorganics.com


Package Label.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


* Please review the disclaimer below.