Earth Mama Baby Mineral Sunscreen Spf 40 Cream
FDA Label NDC 79747-144

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eleeo Brands Llc for the product Earth Mama Baby Mineral Sunscreen Spf 40 (NDC 79747-144). 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

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

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

• 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

* Please review the disclaimer below.