earth mama

earth mama
SPL v4
SPL
SPL Set ID e9a88a57-5733-489d-a459-dd74c04daff2
Route
topical
Published
Effective Date 2024-06-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
zinc oxide (250 mg)
Inactive Ingredients
coconut oil medium-chain triglycerides yellow wax olive oil raspberry seed oil jojoba oil shea butter rice bran oil tocopherol oatmeal aloe vera leaf calendula officinalis flower

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug completed Since 2023-09-12 Until 2026-12-31

Purpose

Sunscreen

Description

Zinc Oxide 25%


Medication Information

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.

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. 

Purpose

Sunscreen

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

Other Information

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

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*, Simmondsia Chinensis (Jojoba) Seed Oil*, Butyrospermum Parkii (Shea) Butter*, Oryza Sativa (Rice) Bran Oil*, Tocopherol, Avena Sativa (Oat) Kernel Flour*, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Calendula Officinalis (Calendula) Flower Extract*

*Organic

Description

Zinc Oxide 25%

Section 42229-5

BROAD SPECTRUM SPF 40

Pediatrician & Dermatologist Tested

Water Resistant (40 Minutes)

UVA/UVB Protection

Non-Nano / Reef-Friendly

Contains Organic Shea Butter & Colloidal Oatmeal

NSF

contains organic ingredients

PLASTIC NEUTRAL

NO Oxybenzone, Octinoxate, Artificial Preservatives or Fragrance

FOR EVERYONE AND THEIR MOTHER. ®

Distributed by Earth Mama Angel Baby ®LLC

9866 SE Empire Ct.  •  Clackamas, OR 97015 USA

Certified to the NSF/ANSI 305 Standard by Oregon Tilth

Awarded the National Eczema Association

Seal of Acceptance TM  •  Leaping Bunny Certified

Section 50565-1

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

Packaging

Drug Facts

Active Ingredient

Zinc Oxide 25%

Questions Or Comments?

503-607-0607 or earthmama.com


Structured Label Content

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.

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. 

Purpose

Sunscreen

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

Other Information

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

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*, Simmondsia Chinensis (Jojoba) Seed Oil*, Butyrospermum Parkii (Shea) Butter*, Oryza Sativa (Rice) Bran Oil*, Tocopherol, Avena Sativa (Oat) Kernel Flour*, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Calendula Officinalis (Calendula) Flower Extract*

*Organic

Section 42229-5 (42229-5)

BROAD SPECTRUM SPF 40

Pediatrician & Dermatologist Tested

Water Resistant (40 Minutes)

UVA/UVB Protection

Non-Nano / Reef-Friendly

Contains Organic Shea Butter & Colloidal Oatmeal

NSF

contains organic ingredients

PLASTIC NEUTRAL

NO Oxybenzone, Octinoxate, Artificial Preservatives or Fragrance

FOR EVERYONE AND THEIR MOTHER. ®

Distributed by Earth Mama Angel Baby ®LLC

9866 SE Empire Ct.  •  Clackamas, OR 97015 USA

Certified to the NSF/ANSI 305 Standard by Oregon Tilth

Awarded the National Eczema Association

Seal of Acceptance TM  •  Leaping Bunny Certified

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.

Packaging

Drug Facts

Active Ingredient

Zinc Oxide 25%

Questions Or Comments? (Questions or comments?)

503-607-0607 or earthmama.com


Advanced Ingredient Data


Raw Label Data

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