Earth Mama Baby Face Mineral Sunscreen Spf 40 (Zinc Oxide) Cream [Earth Mama Angel Baby, Llc] -

EARTH MAMA BABY FACE MINERAL SUNSCREEN SPF 40 (ZINC OXIDE) CREAM [EARTH MAMA ANGEL BABY, LLC]
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NDC	72812-143-01
Set ID	f50eb422-33e1-48c1-8088-b7a8a6ea7068
Category	HUMAN OTC DRUG LABEL
Packager	Earth Mama Angel Baby, LLC
Generic Name
Product Class
Product Number
Application Number	PART352

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Drug Facts

Active Ingredient

Zinc Oxide 22%
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*, Helianthus Annuus

(Sunflower) Seed Oil*, Beeswax (Cera

Alba) (Cire d'abeille)*, Euphorbia Cerifera

Cera (Candelilla Wax), Copernicia Cerifera

(Carnauba) Wax*, Bulyrospermum Parkii

(Shea) Butter*, Tocopherol, Theobroma

Cacao (Cocoa) Seed Butter*, Aloe

Barbadensis Leaf Juice*, Calendula

Officinalis Flower Extract*

*Organic
QUESTIONS

Questions or comments?

503-607-0607 or earthmamaorganics.com
PRINCIPAL DISPLAY PANEL

earth

mama

BABY

Baby Face

Mineral

Sunscreen

NSF

contains organic

ingredients

Non-Nano, NO Parabens,

NO Artificial Fragrance

Broad Spectrum

SPF 40

FACE STICK

Net Wt 21 g (.74 oz)

INGREDIENTS AND APPEARANCE

EARTH MAMA BABY FACE MINERAL SUNSCREEN SPF 40
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72812-143
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	220 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
CANDELILLA WAX (UNII: WL0328HX19)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SHEA BUTTER (UNII: K49155WL9Y)
TOCOPHEROL (UNII: R0ZB2556P8)
COCOA BUTTER (UNII: 512OYT1CRR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:72812-143-01	1 in 1 PACKAGE	04/01/2019
1		21 g in 1 APPLICATOR; Type 0: Not a Combination Product

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

Labeler - Earth Mama Angel Baby, LLC (603560686)

Name	Address	ID/FEI	Business Operations
Establishment
Private Label Select Ltd Co		005415463	manufacture(72812-143)

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Medic

EARTH MAMA BABY FACE MINERAL SUNSCREEN SPF 40 (ZINC OXIDE) CREAM [EARTH MAMA ANGEL BABY, LLC]

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