SPF15 SUNSCREEN LIP BALM- avobenzone, octinoxate, octisalate, octocrylene lipstick
HIGHER EDUCATION SKINCARE, LLC

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.

----------

Vegan Pomegranate SPF 15 Broad Spectrum Sunscreen Lip Balm

Active ingrediets

Avobenzone 3.0%

Octinoxate 7.5%

Octisalate 5.0%

Octocrylene 5.0%

Purpose

sunscreen

Use

helps prevent sunburn

Warnings

on damaged or broken skin

Do not use

on damaged or broken skin

When using this product

keep out of eyes

Stop use and ask doctor if

rash occurs

Keep out of reach of children

Directions

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water-resistance 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

Other Information

protect this product from excessive heat and direct sun

Inactive ingredients

helianthus Annus (Sunflower) Seed Oil, Euphorbia Cerifera ( candelilla) wax, Cocos Nucifera ( Coconut) Oil, Theobroma Cacao( Cocoa) Seed Butter, Pomegranate Flavor, Mixed Tocopherols ( Vitamin E), Aloe Barbadensis ( Aloe Vera) Leaf Oi, Rosmarinus Officinalis ( Rosemary) Leaf Extract, Calendula Officinalis ( Calendula) Flower Extract.

Prinicple Display Panel

Pomegranate SPF 15 Sunscreen

SPF15 SUNSCREEN LIP BALM
avobenzone, octinoxate, octisalate, octocrylene lipstick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72936-777
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
ROSEMARY (UNII: IJ67X351P9)
COCOA BUTTER (UNII: 512OYT1CRR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CANDELILLA WAX (UNII: WL0328HX19)
COCONUT OIL (UNII: Q9L0O73W7L)

Product Characteristics
Color		Score
Shape		Size
Flavor	POMEGRANATE	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72936-777-15	5 g in 1 TUBE; Type 0: Not a Combination Product	04/01/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part352	04/01/2021

Labeler - HIGHER EDUCATION SKINCARE, LLC (081266530)

Registrant - Eco Lips, Inc. (138732727)

Name	Address	ID/FEI	Business Operations
Establishment
Eco Lips, Inc.		138732727	manufacture(72936-777)

Revised: 4/2022

Document Id: ddcea8eb-f670-666e-e053-2995a90a169b

Set id: ddceca1d-3b0f-f711-e053-2a95a90aa542

Version: 1

Effective Time: 20220429

HIGHER EDUCATION SKINCARE, LLC