ALL GOOD COCONUT SPF 20 ZINC OXIDE LIP BALM- zinc oxide stick

All Good Coconut SPF 20 Zinc Oxide Lip Balm by

Drug Labeling and Warnings

All Good Coconut SPF 20 Zinc Oxide Lip Balm by is a Otc medication manufactured, distributed, or labeled by Elemental Herbs, Inc., Eco Lips, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts:

ACTIVE INGREDIENT

Active Ingredient:

Zinc Oxide 8% (Non-nano)

PURPOSE

Purpose:

Sunscreen

INDICATIONS & USAGE

Use: Helps prevent sunburn.

WARNINGS

Warnings: For external use only

Do not use on damaged or broken skin.

Stop use and ask a doctor if rash occurs.

When using this product, keep out of eyes. Rinse with water to remove.

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

DOSAGE & ADMINISTRATION

Directions: Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Children under 6 months of age: ask a doctor.

OTHER SAFETY INFORMATION

Skin Cancer/Skin Aging Alert: spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

INACTIVE INGREDIENT

Inactive Ingredients: Organic Calendula, Organic Comfrey, Organic Lavender, Organic Plantain and Organic Yarrow Infused in Organic Extra Virgin Olive Oil, Organic Beeswax, Organic Castor Oil, Raspberry Seed Oil, Organic Coconut Flavor, and Non-GMO Vitamin E.

SPL UNCLASSIFIED SECTION

All Good SPF 20 Coconut Lip Balm

NET WT 0.15 OZ / 4.25 G

Oxybenzone-free

Made from Plants

ultra zinc protection

MADE IN USA

ALL GOOD

PO BOX 203 MORRO BAY CA 93443

ALLGOODPRODUCTS.COM

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ALL GOOD COCONUT SPF 20 ZINC OXIDE LIP BALM 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75786-224
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	8 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
RASPBERRY SEED OIL (UNII: 9S8867952A)
TOCOPHEROL (UNII: R0ZB2556P8)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
COMFREY LEAF (UNII: DG4F8T839X)
LAVENDER OIL (UNII: ZBP1YXW0H8)
MUSA X PARADISIACA LEAF (UNII: 2UIJ27N6ED)
CASTOR OIL (UNII: D5340Y2I9G)
ACHILLEA MILLEFOLIUM ROOT OIL (UNII: 0S45F449MJ)
YELLOW WAX (UNII: 2ZA36H0S2V)
OLIVE OIL (UNII: 6UYK2W1W1E)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75786-224-01	1 in 1 BOX	01/08/2014
1		4.25 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	01/08/2014

Labeler - Elemental Herbs, Inc. (132776357)

Establishment
Name	Address	ID/FEI	Business Operations
Eco Lips, Inc.		138732727	manufacture(75786-224)