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

Broad Spectrum SPF 15 Peppermint Lip Balm Sunscreen by

Drug Labeling and Warnings

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

Drug Details [pdf]

Drug Facts

Active ingredients

Avobenzone 3%

Octinoxate 7.5%

Octisalate 5%

Octocrylene 5%

Purpose

Sunscreen

Use

• Helps prevent sunburn

Warnings

For external use only

• Do not use on damaged or broken skin

• When using this product keep out of eyes. Rinse with water to remove.

• Stop use and ask a doctor if rash occurs

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 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

Other information

• Protect this product from excessive heat and direct sun

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 or Comments?

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

PRINCIPAL DISPLAY PANEL

NAPLES SOAP COMPANY

SUNSCREEN

Broad Spectrum SPF 15

Lip Balm

.15 oz / 4.25 g

Peppermint

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84489-260
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PEPPERMINT OIL (UNII: AV092KU4JH)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
ROSEMARY (UNII: IJ67X351P9)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
TOCOPHEROL (UNII: R0ZB2556P8)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
YELLOW WAX (UNII: 2ZA36H0S2V)
COCOA BUTTER (UNII: 512OYT1CRR)

Product Characteristics
Color		Score
Shape		Size
Flavor	PEPPERMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84489-260-02	4.25 g in 1 CYLINDER; Type 0: Not a Combination Product	07/02/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/02/2021

Labeler - Naples Soap Company, Inc. (052273536)