FDA.reportPublic FDA data

Earth Mama Mineral Sunscreen SPF 40

Manufacturer
Earth Mama Angel Baby, LLC | Cosmetic Solutions, LLC
Effective date
2023-08-30
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:26:36

Label at a glance#

ProductEarth Mama Mineral Sunscreen SPF 40
Active ingredientZINC OXIDE
Label structure9 sections

Storage and handling

Other Information  Protect the product in this container from exessive heat and direct sun. 

Label contents#

Full prescribing information#

Drug Facts 

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient 

Zinc Oxide 25%

OTC - PURPOSE SECTION

Purpose 

Sunscreen 

INDICATIONS & USAGE SECTION

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 

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use 

  • on damaged or broken skin.

OTC - WHEN USING SECTION

When using this product 

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

OTC - STOP USE SECTION

Stop use and ask a doctor if 

  • rash occurs 

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.  If 

product is swallowed, get medical help

or contact Poison Control Center right 

away. 

DOSAGE & ADMINISTRATION SECTION

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 derease 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 SECTION

Other Information 

  • Protect the product in this container from exessive heat and direct sun. 

INACTIVE INGREDIENT SECTION

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, Argania Spinosa (Argan)

Kernel Oil*, Calendula Officinalis Flower

(Calendula) Flower Extract*

*Organic 

OTC - QUESTIONS SECTION

Questions or comments? 

503-607-0607  or earthmamaorganics.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

earth 

mama

Mineral 

Sunscreen Lotion

Broad Spectrum SPF 40 

Dermatologist tested and

clinically tested for irritation 

Water Resistant (40 Minutes) 

UVA/UVB Protection 

Contains Organic Red Raspberry 

Seed Oil & Organic Argan Oil 

NSF 

contains organic ingredients 

Non-Nano, NO Parabens, 

NO Artificial Fragrance 

Net Wt 84 g (3 oz)

SPF

40

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72812-146-012023-08-31C16284748780-1d6a99b39-35d8-a426-e053-dadaa90af4c2Earth Mama Mineral Sunscreen SPF 40
72812-146-012022-01-28C16284748780-1d6a99b39-35d8-a426-e053-dadaa90af4c2Earth Mama Mineral Sunscreen SPF 40

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72812-14672812-146-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
COCONUT OILQ9L0O73W7LIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
YELLOW WAX2ZA36H0S2VIACT
OLIVE OIL6UYK2W1W1EIACT
RUBUS IDAEUS SEEDM3CL7US2ZGIACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
JOJOBA OIL724GKU717MIACT
SHEA BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
ARGAN OIL4V59G5UW9XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3af333fa-c446-48f6-87e0-dc4d2c3dddc80ce76243-60db-454c-acca-a189366e40b32023-09-13WarningsExact identifier
spl set id: 0ce76243-60db-454c-acca-a189366e40b3

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.