EARTH MAMA UBER-SENSITIVE MINERAL SUNSCREEN SPF 40- zinc oxide lotion 
Earth Mama Angel Baby, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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earth mama® UBER-SENSITIVE MINERAL Sunscreen Lotion

Drug Facts

Active Ingredient

Zinc Oxide 25%

Purpose

Sunscreen

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. • Temporarily protects and helps relieve minor skin irritation and itching due to: • rashes • eczema • poison ivy, oak, or sumac • insect bites. • For use on mild to moderate eczema or as directed by a physician.

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. • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days.

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

Directions

For Eczema: Apply as needed. • 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. • Store at room temperature.

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*

Questions or comments?

503-607-0607 or earthmama.com

THERAPEUTIC ECZEMA
ITCH RELIEF

Pediatrician & Dermatologist Tested

Water Resistant (40 Minutes)

Broad Spectrum
UVA/UVB Protection

Non-Nano / Reef-Safe

Contains Organic Shea Butter & Colloidal Oatmeal

NSF
contains organic ingredients

PLASTIC NEUTRAL

NO Oxybenzone, Octinoxate, Artificial Preservatives or Fragrance

FOR EVERYONE AND THEIR MOTHER.TM

*Organic

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 AcceptanceTM  •  Leaping Bunny Certified

Packaging

SUNSCREEN LOTION-154

EARTH MAMA UBER-SENSITIVE MINERAL SUNSCREEN SPF 40 
zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72812-154
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE250 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
COCONUT OIL (UNII: Q9L0O73W7L)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
RASPBERRY SEED OIL (UNII: 9S8867952A)  
JOJOBA OIL (UNII: 724GKU717M)  
SHEA BUTTER (UNII: K49155WL9Y)  
RICE BRAN OIL (UNII: LZO6K1506A)  
TOCOPHEROL (UNII: R0ZB2556P8)  
OATMEAL (UNII: 8PI54V663Y)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72812-154-0184 g in 1 TUBE; Type 0: Not a Combination Product09/12/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM02009/12/2023
Labeler - Earth Mama Angel Baby, LLC (603560686)

Revised: 9/2023
Document Id: f5610e14-58b0-464c-a33f-0270535363c8
Set id: e9a88a57-5733-489d-a459-dd74c04daff2
Version: 1
Effective Time: 20230912
 
Earth Mama Angel Baby, LLC