FDA.reportPublic FDA data

earth mama ​® TINTED MINERAL Sunscreen Lotion BROAD SPECTRUM SPF 40

Manufacturer
Earth Mama Angel Baby, LLC
Effective date
2025-08-12
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:10:12

Label at a glance#

ProductTinted Mineral Sunscreen Broad Spectrum SPF 40
Active ingredientZINC OXIDE
Label structure10 sections

Indications and 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.

Dosage and administration

• 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, espec...

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 25%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

• 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

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 doctorif • 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.

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

STORAGE AND HANDLING SECTION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Caprylic/Capric Triglyceride*, Cocos Nucifera (Coconut) Oil*, Olea Europaea (Olive) Fruit Oil*, Beeswax*, Rubus Idaeus (Raspberry) Seed Oil*, Punica Granatum Seed Oil*, Simmondsia Chinensis (Jojoba) Oil*, Butyrospermum Parkii (Shea) Butter*, Tocopherol, Argania Spinosa Kernel Oil*, Calendula Officinalis Flower Extract*, Iron Oxides, Mica

*Organic

Questions or comments?

OTC - QUESTIONS SECTION

503-607-0607 or earthmama.com

SPL UNCLASSIFIED SECTION

Dermatologist Tested & Clinically Tested for Irritation

Water Resistant (40 Minutes)

UVA/UVB Protection

Non-Nano  / Reef-Friendly

Contains Organic Red Raspberry Seed Oil & Argan Oil

NSF
contains organic ingredients

PLASTIC NEUTRAL

NO Oxybenzone, Octinoxate, Artificial Preservatives or Fragrance

Moisturizing Tinted Mineral Sun Protection

FOR EVERYONE AND THEIR MOTHER. ®

Distributed by
Earth Mama Angel Baby ®LLC
9866 SE Empire Ct.
Clackamas, OR 97015 USA
Certified to NSF/ANSI 305 by Oregon Tilth
Leaping Bunny Certified

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72812-153-012023-08-31C16284748780-10191ceaa-6ada-198a-e063-dbdaa90aec3eearth mama ​® TINTED MINERAL Sunscreen Lotion BROAD SPECTRUM SPF 40
72812-153-012023-07-28C16284748780-10191ceaa-6ada-198a-e063-dbdaa90aec3eearth mama ​® TINTED MINERAL Sunscreen Lotion BROAD SPECTRUM SPF 40

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72812-153-01Tinted Mineral Sunscreen Broad Spectrum SPF 4084 g in 1 TUBELOTION845

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72812-15372812-153-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
COCONUT OILQ9L0O73W7LIACT
OLIVE OIL6UYK2W1W1EIACT
YELLOW WAX2ZA36H0S2VIACT
RASPBERRY SEED OIL9S8867952AIACT
POMEGRANATE SEED OIL0UI45XV0T6IACT
JOJOBA OIL724GKU717MIACT
SHEA BUTTERK49155WL9YIACT
TOCOPHEROLR0ZB2556P8IACT
ARGAN OIL4V59G5UW9XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
FERRIC OXIDE RED1K09F3G675IACT
MICAV8A1AW0880IACT
ZINC OXIDESOI2LOH54ZACTIB

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
Tinted Mineral Sunscreen Broad Spectrum SPF 40ZINC OXIDEEarth Mama Angel Baby, LLCafc88e77-a4a1-49ec-b021-bb468fd0ac682025-08-12WarningsExact identifier
ndc (package): 72812-153-01
ndc (product): 72812-153
ndc11 (package): 72812015301
spl id: 3c30faa5-e55f-c795-e063-6294a90a419e
spl set id: afc88e77-a4a1-49ec-b021-bb468fd0ac68

Reported adverse events (FAERS/openFDA)#

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