100% PURE SWEET MINT LIP BALM SPF 15- zinc oxide stick

100% Pure Sweet Mint Lip Balm by

Drug Labeling and Warnings

100% Pure Sweet Mint Lip Balm by is a Otc medication manufactured, distributed, or labeled by Purity Cosmetics, Eco Lips, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Zinc Oxide 8.7%

Purpose

Sunscreen

Uses

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early 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.

WHEN USING

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

KEEP OUT OF REACH OF CHILDREN

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

Directions

• Apply liberally 15 minutes before sun exposure.
• Reapply: after 40 minutes of swimming or sweating / immediately after towel drying / at least every 2 hours
• 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 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.
• Children under 6 months: Ask a doctor.

Other Ingredients

*Cerba Alba (Beeswax), Fair Trade Certified™ *Theobroma Cacao (Cocoa) Seed Butter, *Cocos Nucifera (Coconut) Oil, *Rincus Communis (Castor) Seed Oil, * Vanilla Flavor, *Helianthus Annus (Sunflower) Seed Oil, *Persea Gratissima (Avocado) Oil, Mixed Tocopherols (Vitamin E), *Mentha Piperita (Peppermint) Essential Oil, Calophyllum Inophyllum (Tamanu) Oil, Hippophae Rhamnoides (Sea Buckthorn) Fruit Oil, Calendula Officinalis (Calendula) Extract. *Certified Organic

Other information

Protect this product from excessive heat and direct sun.

Questions or comments?

call 1.844.787.3100 or visit www.100PercentPure.com

100% Pure Sweet Mint Lip Balm SPF 15

INGREDIENTS AND APPEARANCE

100% PURE SWEET MINT LIP BALM  SPF 15
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52667-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	87 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
CASTOR OIL (UNII: D5340Y2I9G)
COCOA BUTTER (UNII: 512OYT1CRR)
AVOCADO OIL (UNII: 6VNO72PFC1)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
ARGAN OIL (UNII: 4V59G5UW9X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
TAMANU OIL (UNII: JT3LVK84A1)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
HIPPOPHAE RHAMNOIDES FRUIT OIL (UNII: TA4JCF9S1J)
COCONUT OIL (UNII: Q9L0O73W7L)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52667-005-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	05/01/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/01/2017

Labeler - Purity Cosmetics (055795259)

Establishment
Name	Address	ID/FEI	Business Operations
Eco Lips, Inc.		138732727	manufacture(52667-005)