FDA.reportPublic FDA data

SPF 15 Coconut Lip Balm

Manufacturer
Naples Soap Company, Inc.
Effective date
2024-10-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:36:29

Label at a glance#

ProductSPF 15 Spearmint Lip Balm
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

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 ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

UVA/UVB BROAD SPECTRUM SPF 15

Spearmint Sunscreen Lip Balm

Coconut Sunscreen Lip Balm

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 3.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

  • Do not use on damaged or broken skin

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

OTC - WHEN USING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

OTHER SAFETY INFORMATION

  • Protect this product from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NAPLES SOAP COMPANY

SPF 15

Spearmint Lip Balm

NET WT 0.15 OZ (4.2 g)

SPF 15 Spearmint Lip Balm LabelSPF 15 Spearmint Lip Balm Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NAPLES SOAP COMPANY

SPF 15

Coconut Lip Balm

NET WT 0.15 OZ (4.2 g)

SPF 15 Coconut Lip Balm LabelSPF 15 Coconut Lip Balm Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84489-026-96SPF 15 Coconut Lip Balm4.2 g in 1 CYLINDERSTICK4.21
84489-269-72SPF 15 Spearmint Lip Balm4.2 g in 1 CYLINDERSTICK4.21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84489-026SPF 15 SPEARMINT LIP BALM (ZINC OXIDE) STICK SPF 15 COCONUT LIP BALM (ZINC OXIDE) STICK [NAPLES SOAP COMPANY, INC.]1Current NDC, 1 package rows20241111_25a7510f-5ef3-9920-e063-6394a90a2079.zip
84489-269SPF 15 SPEARMINT LIP BALM (ZINC OXIDE) STICK SPF 15 COCONUT LIP BALM (ZINC OXIDE) STICK [NAPLES SOAP COMPANY, INC.]1Current NDC, 1 package rows20241111_25a7510f-5ef3-9920-e063-6394a90a2079.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84489-26984489-269-72
84489-02684489-026-96

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
YELLOW WAX2ZA36H0S2VIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
OLIVE OIL6UYK2W1W1EIACT
TOCOPHEROLR0ZB2556P8IACT
PLANTAGO MAJOR LEAF7DC28K241XIACT
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAIACT
SPEARMINT OILC3M81465G5IACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
COMFREY LEAFDG4F8T839XIACT
PLANTAGO MAJOR LEAF7DC28K241XIACT
ZINC OXIDESOI2LOH54ZACTIB
YELLOW WAX2ZA36H0S2VIACT
LAVANDULA ANGUSTIFOLIA FLOWER19AH1RAF4MIACT
OLIVE OIL6UYK2W1W1EIACT
TOCOPHEROLR0ZB2556P8IACT
ACHILLEA MILLEFOLIUM FLOWERYQR8R0SQEAIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
COMFREY LEAFDG4F8T839XIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SPF 15 Coconut Lip BalmZINC OXIDENaples Soap Company, Inc.25a7510f-5ef3-9920-e063-6394a90a20792024-10-29WarningsExact identifier
ndc (package): 84489-026-96
ndc (package): 84489-269-72
ndc (product): 84489-269
ndc (product): 84489-026
ndc11 (package): 84489002696
ndc11 (package): 84489026972
spl id: 25a7510f-5ef4-9920-e063-6394a90a2079
spl set id: 25a7510f-5ef3-9920-e063-6394a90a2079

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.