MedPath

Tinted Mineral Sunscreen Broad Spectrum SPF 25

earth mama Broad Spectrum SPF

Approved
Approval ID

2aa44439-663a-400b-b432-e2dc5ac2a3d1

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 12, 2025

Manufacturers
FDA

Earth Mama Angel Baby, LLC

DUNS: 603560686

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Zinc Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72812-152
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateAugust 12, 2025
FDA Product Classification

INGREDIENTS (15)

MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
COCONUT OILInactive
Code: Q9L0O73W7L
Classification: IACT
OLIVE OILInactive
Code: 6UYK2W1W1E
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
SUNFLOWER OILInactive
Code: 3W1JG795YI
Classification: IACT
JOJOBA OILInactive
Code: 724GKU717M
Classification: IACT
SHEA BUTTERInactive
Code: K49155WL9Y
Classification: IACT
RASPBERRY SEED OILInactive
Code: 9S8867952A
Classification: IACT
ARGAN OILInactive
Code: 4V59G5UW9X
Classification: IACT
TOCOPHEROLInactive
Code: R0ZB2556P8
Classification: IACT
ROSA CANINA SEED OILInactive
Code: MHT97MG5P8
Classification: IACT
CALENDULA OFFICINALIS FLOWERInactive
Code: P0M7O4Y7YD
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
MICAInactive
Code: V8A1AW0880
Classification: IACT
ZINC OXIDEActive
Quantity: 200 mg in 1 g
Code: SOI2LOH54Z
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/7/2022

Packaging

IMAGE

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/7/2022

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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 2/11/2022

Dermatologist Tested & Clinically Tested for Irritation

Water Resistant (40 Minutes)

UVA/UVB Protection

Reef Friendly

Contains Organic Argan Oil & Organic Raspberry Seed Oil

Non-Nano, NO Parabens, NO Artificial Fragrance

NSF
contains organic ingredients

Tinted Moisturizing

Mineral Sun Protection

Grounded in Nature, Powered by Love.™

Distributed by

Earth Mama Angel Baby ®LLC

9866 SE Empire Ct.

Clackamas, OR 97015 USA

Certified to NSF/ANSI

305 by Oregon Tilth

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/7/2022

Active Ingredient

Zinc Oxide 20%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/7/2022

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 2/7/2022

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 doctorif • rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/7/2022

​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 SECTION

LOINC: 44425-7Updated: 2/7/2022

Other Information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/11/2022

Inactive Ingredients

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

*Organic

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/7/2022

Questions or comments?

503-607-0607 or earthmamaorganics.com

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Tinted Mineral Sunscreen Broad Spectrum SPF 25 - FDA Drug Approval Details