TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 25- zinc oxide lotion

Tinted Mineral Sunscreen Broad Spectrum SPF 25 by

Drug Labeling and Warnings

Tinted Mineral Sunscreen Broad Spectrum SPF 25 by is a Otc medication manufactured, distributed, or labeled by Earth Mama Angel Baby, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Zinc Oxide 20%

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.

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.

​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

Caprylic/Caprylic Triglyceride*, Cocos Nucifera (Coconut) Oil*, Olea Europaea (Olive) Fruit Oil*, Beeswax*, Helianthus Annuus (Sunflower) Seed Oil*, Simmondsia Chinensis (Jojoba) Oil*, Butyrospermum Parkii (Shea) Butter*, Rubus Idaeus (Raspberry) Seed Oil*, Argania Spinosa Kernel Oil*, Tocopherol, Rosa Canina (Rosehip) Seed Oil*, Calendula Officinalis Flower Extract*, Iron Oxides, Mica

*Organic

Questions or comments?

503-607-0607 or earthmamaorganics.com

SPL UNCLASSIFIED SECTION

Dermatologist Tested & Clinically Tested for Irritation

Water Resistant (40 Minutes)

UVA/UVB Protection

Reef Friendly

Contains Organic Argan Oil & Organic Raspberry Seed Oil

Non-Nano, NO Parabens, NO Artificial Fragrance

NSF
contains organic ingredients

Tinted Moisturizing

Mineral Sun Protection

Grounded in Nature, Powered by Love.™

Distributed by

Earth Mama Angel Baby® LLC

9866 SE Empire Ct.

Clackamas, OR 97015 USA

Certified to NSF/ANSI

305 by Oregon Tilth

Packaging

INGREDIENTS AND APPEARANCE

TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 25 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72812-152
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
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
RASPBERRY SEED OIL (UNII: 9S8867952A)
ARGAN OIL (UNII: 4V59G5UW9X)
TOCOPHEROL (UNII: R0ZB2556P8)
ROSA CANINA SEED OIL (UNII: MHT97MG5P8)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
FERRIC OXIDE RED (UNII: 1K09F3G675)
MICA (UNII: V8A1AW0880)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72812-152-01	84 g in 1 TUBE; Type 0: Not a Combination Product	08/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/01/2020

Labeler - Earth Mama Angel Baby, LLC (603560686)