Earth Mama Baby Mineral Sunscreen Spf 40 Cream
FDA Label NDC 72812-144

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Earth Mama Angel Baby, Llc for the product Earth Mama Baby Mineral Sunscreen Spf 40 (NDC 72812-144). 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, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, 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%

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.