Earth Mama ®

Earth Mama ®
SPL v5
SPL
SPL Set ID 2aa44439-663a-400b-b432-e2dc5ac2a3d1
Route
TOPICAL
Published
Effective Date 2022-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (200 mg)
Inactive Ingredients
Medium-chain Triglycerides Coconut Oil Olive Oil Yellow Wax Sunflower Oil Jojoba Oil Shea Butter Raspberry Seed Oil Argan Oil Tocopherol Rosa Canina Seed Oil Calendula Officinalis Flower Ferric Oxide Red Mica

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-08-01 Until 2026-12-31

Description

Zinc Oxide 20%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 20%

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.

Section 42229-5

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

Section 50565-1

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

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

Packaging

Drug Facts

​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

Active Ingredient

Zinc Oxide 20%

Other Information

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

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

Questions Or Comments?

503-607-0607 or earthmamaorganics.com


Structured Label Content

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.

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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

Purpose

Sunscreen

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

Packaging

Drug Facts

​directions (​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

Active Ingredient

Zinc Oxide 20%

Other Information

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

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

Questions Or Comments? (Questions or comments?)

503-607-0607 or earthmamaorganics.com


Advanced Ingredient Data


Raw Label Data

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