ECO LIPS PLANTPOD SUNSCREEN LIP BALM BERRY SPF 15- avobenzone, octinoxate, octisalate, octocrylene stick

Eco Lips PlantPod Sunscreen Lip Balm Berry by

Drug Labeling and Warnings

Eco Lips PlantPod Sunscreen Lip Balm Berry 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 ingredients

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Use

helps prevent sunburn

WARNINGS

Warnings

Do not useon damaged or broken skin

When using this productkeep out of eyes

Stop use and ask a doctor ifrash occurs

Keep out of reach of children.

DOSAGE & ADMINISTRATION

Directions

• apply liberally 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water-resistant sunscreen if swimming or sweating
• 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
• children under 6 months of age: ask a doctor

STORAGE AND HANDLING

Other information

protect this product from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive ingredients

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

* Certified 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

INDIVIDUAL TUBE LABEL

ECO LIPS®

SPF 15

PLANTPOD BERRY

Broad Spectrum SPF 15 Sunscreen Lip Balm

Net Wt.. .15oz (4.25g)

BLISTER PACK CARTON PDP

ECO LIPS®

PLANTPOD

BROAD SPECTRUM SPF 15 SUNSCREEN LIP BALM

BERRY

WITH SOOTHING ALOE VERA

UVA/UVB PROTECTION

Net Wt. .15 oz (4.25g)

INGREDIENTS AND APPEARANCE

ECO LIPS PLANTPOD SUNSCREEN LIP BALM BERRY  SPF 15
avobenzone, octinoxate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 75071-005
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
ROSEMARY OIL (UNII: 8LGU7VM393)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
COCOA BUTTER (UNII: 512OYT1CRR)
TOCOPHEROL (UNII: R0ZB2556P8)
COCONUT OIL (UNII: Q9L0O73W7L)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75071-005-04	4.25 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2022
2	NDC: 75071-005-01	1 in 1 BLISTER PACK	07/01/2022
2		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	03/01/2022

Labeler - Eco Lips. Inc. (138732727)

Establishment
Name	Address	ID/FEI	Business Operations
Eco Lips, Inc.		138732727	manufacture(75071-005)