Broad Spectrum SPF 15 Peppermint Lip Balm Sunscreen by Naples Soap Company, Inc.

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]

BROAD SPECTRUM SPF 15 PEPPERMINT LIP BALM SUNSCREEN- avobenzone, octinoxate, octisalate, and octocrylene stick 
Naples Soap Company, Inc.

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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

NAPLES SOAP COMPANY

SUNSCREEN

Broad Spectrum SPF 15

Lip Balm

.15 oz / 4.25 g

Peppermint

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	12/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/02/2021	12/30/2024

Labeler - Naples Soap Company, Inc. (052273536)

Revised: 12/2024

Document Id: 2a84670b-af68-1973-e063-6294a90a3dbd

34390-5

Set id: 26aa3e84-d807-943f-e063-6394a90a3e80

Version: 2

Effective Time: 20241230