SPF 15 SPEARMINT LIP BALM- zinc oxide stick SPF 15 COCONUT LIP BALM- zinc oxide stick

SPF 15 Coconut Lip Balm by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

UVA/UVB BROAD SPECTRUM SPF 15

Spearmint Sunscreen Lip Balm

Coconut Sunscreen Lip Balm

Drug Facts

Active ingredient

Zinc Oxide 3.5%

Purpose

Sunscreen

Uses

• Helps prevent sunburn

Warnings

For external use only

• Do not use on damaged or broken skin

• Stop use and ask a doctor if rash occurs

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

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
• Use a water resistant sunscreen if swimming or sweating
• Reapply at least every 2 hours
• Children under 6 months of age: Ask a doctor

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

Other information

• Protect this product from excessive heat and direct sun

Inactive ingredients

Organic Calendula, Organic Comfrey, Organic Lavender, Organic Plantain and Organic Yarrow Infused in Organic Extra Virgin Olive Oil with Organic Beeswax, Organic Coconut Flavor and Non-GMO Vitamin E.

PRINCIPAL DISPLAY PANEL

NAPLES SOAP COMPANY

SPF 15

Spearmint Lip Balm

NET WT 0.15 OZ (4.2 g)

PRINCIPAL DISPLAY PANEL

NAPLES SOAP COMPANY

SPF 15

Coconut Lip Balm

NET WT 0.15 OZ (4.2 g)

INGREDIENTS AND APPEARANCE

SPF 15 SPEARMINT LIP BALM 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84489-269
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
OLIVE OIL (UNII: 6UYK2W1W1E)
TOCOPHEROL (UNII: R0ZB2556P8)
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)
SPEARMINT OIL (UNII: C3M81465G5)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
COMFREY LEAF (UNII: DG4F8T839X)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84489-269-72	4.2 g in 1 CYLINDER; Type 0: Not a Combination Product	08/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/02/2022

SPF 15 COCONUT LIP BALM 
zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84489-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	35 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PLANTAGO MAJOR LEAF (UNII: 7DC28K241X)
YELLOW WAX (UNII: 2ZA36H0S2V)
LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)
OLIVE OIL (UNII: 6UYK2W1W1E)
TOCOPHEROL (UNII: R0ZB2556P8)
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
COMFREY LEAF (UNII: DG4F8T839X)

Product Characteristics
Color		Score
Shape		Size
Flavor	COCONUT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84489-026-96	4.2 g in 1 CYLINDER; Type 0: Not a Combination Product	08/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/02/2022

Labeler - Naples Soap Company, Inc. (052273536)