ECO LIPS ZINC SUNSCREEN LIP BALM BROAD SPECTRUM SPF 15 COCONUT VANILLA- zinc oxide stick

Eco Lips Zinc Sunscreen Lip Balm by

Drug Labeling and Warnings

Eco Lips Zinc Sunscreen Lip Balm by is a Otc medication manufactured, distributed, or labeled by Eco Lips. Inc., Eco Lips, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredient

Zinc Oxide 20%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Use

helps prevent sunburn

WARNINGS

Warnings

For external use only

Do not useon damaged or broken skin

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions for Sunscreen Use:

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating.
• 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
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats and sunglasses

STORAGE AND HANDLING

Other information

protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients

*Olea Europaea (Olive) Fruit Oil, *Cera Flava (Beeswax), *†Cocos Nucifera (Coconut) Oil, *†Theobroma Cacao (Cocoa) Seed Butter, *Coconut Flavor, *Copernical Cerifera (Carnauba) Wax, *Vanilla Flavor, Mixed Tocopherols (Vitamin E).

*Organic Ingredient † Fair Trade Certified™ by Fair Trade USA 20% of Product

QUESTIONS

Questions or comments?

1-866-326-5477

SPL UNCLASSIFIED SECTION

ECO LIPS, INC. | CEDAR RAPIDS, IA 52402

ECOLIPS.COM

MANUFACTURED IN USA

CERTIFIED TO NSF/ANSI 305 BY OREGON TILTH

PRINCIPAL DISPLAY PANEL

ECO LIPS®

ZINC

BROAD SPECTRUM SPF 15

SUNSCREEN LIP BALM

COCONUT VANILLA

Moisturize and protect with olive oil, coconut oil & cocoa butter.

Coral Reef Safe

Net Wt. .15 oz (4.25g)

INGREDIENTS AND APPEARANCE

ECO LIPS ZINC SUNSCREEN LIP BALM  BROAD SPECTRUM SPF 15 COCONUT VANILLA
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75071-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	20 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
VANILLA (UNII: Q74T35078H)
OLIVE OIL (UNII: 6UYK2W1W1E)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCOA BUTTER (UNII: 512OYT1CRR)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)

Product Characteristics
Color		Score
Shape		Size
Flavor	COCONUT, VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75071-004-01	1 in 1 BLISTER PACK	04/01/2021
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 Drug	M020	04/01/2021

Labeler - Eco Lips. Inc. (138732727)

Establishment
Name	Address	ID/FEI	Business Operations
Eco Lips, Inc.		138732727	manufacture(75071-004)