earth mama baby mineral sunscreen spf 40

earth mama baby mineral sunscreen spf 40
SPL v6
SPL
SPL Set ID 74475fba-4cdd-4b27-8ea4-646f4016580c
Route
topical
Published
Effective Date 2024-06-21
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 rubus idaeus seed pomegranate seed oil jojoba oil shea butter tocopherol calendula officinalis flower

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug completed Since 2019-04-01 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 doctor if • 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*, Punica Granatum (Pomegranate) Seed Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*,Butyrospermum Parkii (Shea) Butter*, Tocopherol, Calendula Officinalis (Calendula) Flower Extract*

*Organic

Description

Zinc Oxide 25%

Section 42229-5

BROAD SPECTRUM SPF 40

Pediatrician Tested

Dermatologist Tested & Clinically Tested for Irritation

Water Resistant (40 Minutes)

UVA/UVB Protection

Non-Nano / Reef-Friendly

Contains Organic Shea Butter & Calendula

NSF

contains organic ingredients

PLASTIC NEUTRAL

NO Oxybenzone, Octinoxate, Artificial Preservatives or Fragrance

Gently Moisturizing 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

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 doctor if • 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*, Punica Granatum (Pomegranate) Seed Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*,Butyrospermum Parkii (Shea) Butter*, Tocopherol, Calendula Officinalis (Calendula) Flower Extract*

*Organic

Section 42229-5 (42229-5)

BROAD SPECTRUM SPF 40

Pediatrician Tested

Dermatologist Tested & Clinically Tested for Irritation

Water Resistant (40 Minutes)

UVA/UVB Protection

Non-Nano / Reef-Friendly

Contains Organic Shea Butter & Calendula

NSF

contains organic ingredients

PLASTIC NEUTRAL

NO Oxybenzone, Octinoxate, Artificial Preservatives or Fragrance

Gently Moisturizing 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

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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