TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 40- zinc oxide lotion

Tinted Mineral Sunscreen Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Tinted Mineral Sunscreen Broad Spectrum SPF 40 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 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.

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/Capric Triglyceride*, Cocos Nucifera (Coconut) Oil*, Olea Europaea (Olive) Fruit Oil*, Beeswax*, Rubus Idaeus (Raspberry) Seed Oil*, Punica Granatum Seed Oil*, Simmondsia Chinensis (Jojoba) Oil*, Butyrospermum Parkii (Shea) Butter*, Tocopherol, Argania Spinosa Kernel Oil*, Calendula Officinalis Flower Extract*, Iron Oxides, Mica

*Organic

Questions or comments?

503-607-0607 or earthmama.com

SPL UNCLASSIFIED SECTION

Dermatologist Tested & Clinically Tested for Irritation

Water Resistant (40 Minutes)

UVA/UVB Protection

Non-Nano  / Reef-Friendly

Contains Organic Red Raspberry Seed Oil & Argan Oil

NSF
contains organic ingredients

PLASTIC NEUTRAL

NO Oxybenzone, Octinoxate, Artificial Preservatives or Fragrance

Moisturizing Tinted 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

Packaging

INGREDIENTS AND APPEARANCE

TINTED MINERAL SUNSCREEN BROAD SPECTRUM SPF 40 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72812-153
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
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
COCONUT OIL (UNII: Q9L0O73W7L)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
RASPBERRY SEED OIL (UNII: 9S8867952A)
POMEGRANATE SEED OIL (UNII: 0UI45XV0T6)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
ARGAN OIL (UNII: 4V59G5UW9X)
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: 72812-153-01	84 g in 1 TUBE; Type 0: Not a Combination Product	09/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	09/01/2020

Labeler - Earth Mama Angel Baby, LLC (603560686)