PEPPERMINT SPF 15 SUNSCREEN LIP BALM- avobenzone, octinoxate, octisalate, octocrylene stick

Peppermint SPF 15 Sunscreen Lip Balm by

Drug Labeling and Warnings

Peppermint SPF 15 Sunscreen Lip Balm by is a Otc medication manufactured, distributed, or labeled by Naples Soap Company, Inc., Eco Lips, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 use on damaged or broken skin

When using this product, keep out of eyes

Stop use and ask a doctor if rash 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 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

STORAGE AND HANDLING

Other informationprotect 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*, Essential Oil of Mentha Piperita (Peppermint) Leaf Oil*, Aloe Barbadensis (Aloe Vera) Leaf Oil*, Mixed Tocopherols (Vitamin E), Rosmarinus Officinalis (Rosemary) Leaf Extract*, Calendula Officinalis (Calendula) Flower Extract*. *Organic Ingredient

QUESTIONS

Questions or comments?

Questions? 1-888-256-8265 or visit www.naplessoap.com

SPL UNCLASSIFIED SECTION

NAPLES

SOAP COMPANY

SUNSCREEN

Broad spectrum SPF 15

-15-

Lip Balm

.15 oz / 4.25 g

Peppermint

Distributed by: Naples Soap Company

Fort Myers, FL 33913

naplessoap.com - (239) 325-8263

Made in USA from

foreign & domestic parts - 84489

PRINCIPAL DISPLAY PANEL

Net Wt. 0.15 oz (4.25 g)

INGREDIENTS AND APPEARANCE

PEPPERMINT SPF 15 SUNSCREEN LIP BALM 
avobenzone, octinoxate, octisalate, octocrylene stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84489-101
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
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

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT (UNII: V95R5KMY2B)
ROSEMARY (UNII: IJ67X351P9)
COCOA BUTTER (UNII: 512OYT1CRR)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
TOCOPHEROL (UNII: R0ZB2556P8)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
SUNFLOWER OIL (UNII: 3W1JG795YI)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCONUT OIL (UNII: Q9L0O73W7L)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84489-101-01	4.25 g in 1 TUBE; Type 0: Not a Combination Product	01/27/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	01/27/2021

Labeler - Naples Soap Company, Inc. (052273536)

Registrant - Eco Lips, Inc. (138732727)