Eco Lips Sport Lip Balm SPF 30 by Eco Lips. Inc. / Eco Lips, Inc. Eco Lips Sport Lip Balm

Eco Lips Sport Lip Balm SPF 30 by

Drug Labeling and Warnings

Eco Lips Sport Lip Balm SPF 30 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]

ECO LIPS SPORT LIP BALM SPF 30- avobenzone, octinoxate, octisalate stick 
Eco Lips. Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Eco Lips Sport Lip Balm

Drug Facts

Active Ingredients:

Avobenzone (5%)

Octinoxate (10%)

Octisalate (5%)

Purpose:

Sunscreen

Uses

• helps prevent sunburn.

Warnings

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

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.

Directions

• apply liberally 15 minutes before sun exposure.
• reapply:
• immediately after towel drying
• at least every 2 hours
• use a water resistant sunscreen if swimming or sweating.
• children under 6 months of age: Ask a doctor

Inactive ingredients

*Aloe Barbadensis (Aloe Vera) Leaf Oil, *Calendula Officinalis (Calendula) Flower Extract, *Cera Flava (Beeswax), *+ Cocos Nucifera (Coconut) Oil, *Helianthus Annuus (Sunflower) Seed Oil, *+Theobroma Cacao Seed Butter, Mixed Tocopherols (Vitamin E), *Vanilla Flavor.

*Organic Ingredients +Fair Trade Certified™

Other information

Protect this product from excessive heat and direct sunlight.

Questions or Comments?

Call 1.866.326.5477

ECO LIPS, Inc.

Marion, IA 52302

ecolips.com

Made in USA

SPF30

ECO LIPS® SPORT

LIP BALM

Net Wt. .15 oz (4.25g)

ECO LIPS SPORT LIP BALM SPF 30 
avobenzone, octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75071-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	5 g  in 100 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	10 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCOA BUTTER (UNII: 512OYT1CRR)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
COCONUT OIL (UNII: Q9L0O73W7L)

Product Characteristics
Color		Score
Shape		Size
Flavor	VANILLA	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75071-001-04	4.25 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2017	11/30/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/01/2017	11/30/2022

Labeler - Eco Lips. Inc. (138732727)

Establishment
Name	Address	ID/FEI	Business Operations
Eco Lips, Inc.		138732727	manufacture(75071-001)

Revised: 6/2020

Document Id: a70e8c19-87bb-163e-e053-2995a90a931e

34390-5

Set id: a70e8c19-87ba-163e-e053-2995a90a931e

Version: 1

Effective Time: 20200601