FDA.reportPublic FDA data

Sun Care SPF 30 Facestick

Manufacturer
Naples Soap Co.
Effective date
2024-07-11
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:15:29

Label at a glance#

ProductSun Care SPF 30 Facestick SPF 30
Active ingredientOCTINOXATE, OXYBENZONE, AVOBENZONE, OCTISALATE
Label structure11 sections

Storage and handling

Other information protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%, Oxybenzone 4%

OTC - PURPOSE SECTION

Purpose

Sunscreen

INDICATIONS & USAGE SECTION

Usehelps prevent sunburn

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

When using this product,keep out of eyes

OTC - STOP USE SECTION

Stop use and ask a doctor ifrash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Other informationprotect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive ingredients*Helianthus Annuus (Sunflower) Seed Oil, *Cera Flava (Beeswax), *Cocos Nucifera (Coconut Oil), *Theobroma Cacao (Cocoa Seed) Butter, Mixed Tocopherols (Vitamin E), *Aloe Barbadensis (Aloe Vera) Leaf Oil, *Rosmarinus Officinalis (Rosemary) Leaf Extract, *Calendula Officinalis (Calendula) Flower Extract. *Organic Ingredient

SPL UNCLASSIFIED SECTION

SPF 30

NAPLES

SOAP COMPANY

NATURALLY BETTER

SKIN CARE

SUN CARE

Broad Spectrum Sunscreen

SPF 30

Face Stick

0.56 oz (17g)

Distributed by Naples Soap Company,FL 33913

Questions? 239-325-8263 or

visit www.naplessoap.com

Made in the U.S.A. with Imported Ingredients

Net Wt. .56 oz (17g) Peel here for drug facts

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Net Wt. .56 oz (17 g)

Naples Soap SPF 30 Facestick Broad Spectrum Tube Label 0.56 ozNaples Soap SPF 30 Facestick Broad Spectrum Tube Label 0.56 oz

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84489-166-01Sun Care SPF 30 FacestickSPF 3017 g in 1 TUBESTICK171

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84489-166SUN CARE SPF 30 FACESTICK SPF 30 (AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE) STICK [NAPLES SOAP CO.]1Current NDC, 1 package rows20240719_1cfb91dc-178e-fd5d-e063-6394a90a5300.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84489-16684489-166-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ROSEMARY OIL8LGU7VM393IACT
ALOE VERA LEAFZY81Z83H0XIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
YELLOW WAX2ZA36H0S2VIACT
SUNFLOWER OIL3W1JG795YIIACT
COCOA BUTTER512OYT1CRRIACT
TOCOPHEROLR0ZB2556P8IACT
COCONUT OILQ9L0O73W7LIACT
OCTINOXATE4Y5P7MUD51ACTIB
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB

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
Sun Care SPF 30 Facestick SPF 30AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONENaples Soap Co.1cfb91dc-178e-fd5d-e063-6394a90a53002024-07-11WarningsExact identifier
ndc (package): 84489-166-01
ndc (product): 84489-166
ndc11 (package): 84489016601
spl id: 1cfb91aa-6c82-0b25-e063-6394a90a4132
spl set id: 1cfb91dc-178e-fd5d-e063-6394a90a5300

Reported adverse events (FAERS/openFDA)#

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