EARTH MAMA BABY MINERAL SUNSCREEN SPF 40- zinc oxide cream

Earth Mama Baby Mineral Sunscreen SPF 40 by

Drug Labeling and Warnings

Earth Mama Baby Mineral Sunscreen SPF 40 by is a Otc medication manufactured, distributed, or labeled by Earth Mama Angel Baby, LLC, Cosmetic Solutions, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts 

Active Ingredient 

Zinc Oxide 25%

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)*, Olea 

Europaea (Olive) Fruit Oil*, Rubus Idaeus (Red 

Raspberry) Seed Oil*, Punica Granatum

(Pomegranate) Seed Oil*, Simmondsia 

Chinensis (Jojoba) Oil*, Butyrospermum Parkii

(Shea) Butter*, Tocopherol, Calendula 

Officinalis Flower (Calendula) Flower Extract*

*Organic 

QUESTIONS

Questions or comments? 

503-607-0607  or earthmamaorganics.com

PRINCIPAL DISPLAY PANEL

earth 

mama

BABY

Mineral 

Sunscreen Lotion 

Broad Spectrum SPF 40

Pediatrician Tested 

Dermatologist tested and 

clinically tested for irritation 

Water Resistant (40 Minutes)

UVA/UVB Protection 

NSF

contains organic ingredients 

Contains Organic Shea Butter

& Organic Calendula

Non-Nano, NO Parabens, NO Artificial Fragrance 

Net Wt 84 g (3 oz)

SPF

40

INGREDIENTS AND APPEARANCE

EARTH MAMA BABY MINERAL SUNSCREEN SPF 40 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72812-144
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	250 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
COCONUT OIL (UNII: Q9L0O73W7L)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
YELLOW WAX (UNII: 2ZA36H0S2V)
OLIVE OIL (UNII: 6UYK2W1W1E)
RUBUS IDAEUS SEED (UNII: M3CL7US2ZG)
PUNICA GRANATUM SEED OIL (UNII: 0UI45XV0T6)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
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: 72812-144-01	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(72812-144)