EARTH MAMA MINERAL SUNSCREEN SPF 25- zinc oxide cream

Earth Mama Mineral Sunscreen SPF 25 by

Drug Labeling and Warnings

Earth Mama Mineral Sunscreen SPF 25 by is a Otc medication manufactured, distributed, or labeled by Earth Mama Angel Baby, LLC, Private Label Select Ltd Co. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active Ingredient 

Zinc Oxide 20%

PURPOSE

Purpose 

Sunscreen 

INDICATIONS & USAGE

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. 

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 

Keep out of reach of children.  If 

product is swallowed, get medical help

or contact Poison Control Center right 

away. 

DOSAGE & ADMINISTRATION

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

Other Information 

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

INACTIVE INGREDIENT

Inactive Ingredients Cocos Nucifera

(Coconut) Oil*, Cocos nucifera (Fractionated

Coconut) Oil*, Cera Alba (Beeswax)*, Helianthus Annus (Sunflower) Seed Oil*,

Olea Europaea (Olive) Fruit Oil*, Simmondsia 

Chinensis (Jojoba) Oil*, Butyrospermum Parkii

(Shea) Butter*, Tocopherol, Rubus Idaeus (Red Raspberry) Seed Oil*,

Argania Spinosa (Argan) Kernel Oil*,

Rosa Canina (Rosehip) Seed Oil*, Calendula 

Officinalis (Calendula) Flower Extract*

*Organic 

QUESTIONS

Questions or comments? 

503-607-0607  or earthmamaorganics.com

PRINCIPAL DISPLAY PANEL

earth 

mama

Mineral 

Sunscreen Lotion 

Broad Spectrum SPF 25

Dermatologist tested and

clinically tested for irritation

Water Resistant (40 Minutes)

UVA/UVB Protection 

Contains Organic Argan Oil &

Organic Red Raspberry Seed Oil

Non-Nano, NO Parabens,

NO Artificial Fragrance 

NSF 

contains organic ingredients 

Net Wt 84 g (3 oz)

SPF

25

INGREDIENTS AND APPEARANCE

EARTH MAMA MINERAL SUNSCREEN SPF 25 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72812-145
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	200 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLIVE OIL (UNII: 6UYK2W1W1E)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
ARGAN OIL (UNII: 4V59G5UW9X)
ROSA CANINA SEED (UNII: 4503R1M9UT)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72812-145-01	84 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	04/01/2019

Labeler - Earth Mama Angel Baby, LLC (603560686)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Select Ltd Co		005415463	manufacture(72812-145)