Earth Mama Uber-sensitive Mineral Sunscreen Spf 40 Lotion
FDA Label NDC 72812-154
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Earth Mama Angel Baby, Llc for the product Earth Mama Uber-sensitive Mineral Sunscreen Spf 40 (NDC 72812-154). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
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.
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
Packaging
Sunscreen Lotion-154 (7281215401)
* Please review the disclaimer below.
