FDA.reportPublic FDA data

SPF 50 Florida Sun Defense

Manufacturer
Naples Soap Company, Inc.
Effective date
2026-01-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:35:48

Label at a glance#

ProductSPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body Oil
Active ingredientOCTOCRYLENE, HOMOSALATE, OCTISALATE
Label structure10 sections

Indications and uses

Helps prevent sunburn lf used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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 protecti...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • lf used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • ​on damaged or broken skin

OTC - WHEN USING SECTION

When using this product

  • keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • rash occurs

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 generously and evenly 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating
  • 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 the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Butyloctyl Salicylate, Octyldodecanol, C12-15 Alkyl Benzoate, Polyester-8, Polyamide-3, Lauryl Lactate, Diisopropyl Sebacate, Diethylhexyl Syringylidenemalonate, Tocopherol, Vitis Vinifera (Grape) Seed Oil, Raphanus Sativus (Radish) Seed Extract, Limnanthes Alba (Meadowfoam) Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Butyrospermum Parkii (Shea) Butter, Argania Spinosa Kernel Oil, Camellia Sinensis Extract, Cucumis Sativus (Cucumber) Fruit Extract, Citric Acid

Questions or Comments?

OTC - QUESTIONS SECTION

Call (239) 325-8263 or email info@naplessoap.com

PRINCIPAL DISPLAY PANEL - 100 ML CARTON LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NAPLES

SOAP COMPANY

NATURALLY BETTER

SKIN CARE

SPF

50

FLORIDA

SUN DEFENSE

Broad Spectrum SPF 50

Sunscreen

Body Oil

3.4 fl oz / 100 mL

Sunscreen Body OilSunscreen Body Oil

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84489-100-34SPF 50 Florida Sun DefenseBroad Spectrum SPF 50 Sunscreen Body Oil100 mL in 1 BOTTLE, PUMPOIL1001
84489-100-34SPF 50 Florida Sun DefenseBroad Spectrum SPF 50 Sunscreen Body Oil1 in 1 CARTONOIL11

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84489-10084489-100-34

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
POLYAMIDE-3 (20000 MW)PLF06VZ9SQIACT
OCTYLDODECANOL461N1O614YIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
LAURYL LACTATEG5SU0BFK7OIACT
DIETHYLHEXYL SYRINGYLIDENEMALONATE3V5U97P248IACT
GRAPE SEED OIL930MLC8XGGIACT
LIMNANTHES ALBA (MEADOWFOAM) SEED OIL412ZHA4T4YIACT
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL3W1JG795YIIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
CUCUMBERYY7C30VXJTIACT
CITRIC ACID2968PHW8QPIACT
HOMOSALATEV06SV4M95SACTIB
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
OCTISALATE4X49Y0596WACTIB
DIISOPROPYL SEBACATEJ8T3X564IHIACT
TOCOPHEROLR0ZB2556P8IACT
RAPHANUS SATIVUS VAR. SATIVUS SEEDA94I086Q5EIACT
COCOS NUCIFERA (COCONUT) OILQ9L0O73W7LIACT
ARGANIA SPINOSA KERNEL OIL4V59G5UW9XIACT
CAMELLIA SINENSIS WHOLEC5M4585ZBZIACT

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 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body OilHOMOSALATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.47c147a9-c4f4-ab82-e063-6394a90aaa5c2026-01-06WarningsExact identifier
ndc (package): 84489-100-34
ndc (product): 84489-100
ndc11 (package): 84489010034
spl id: 47c147a9-c4f5-ab82-e063-6394a90aaa5c
spl set id: 47c147a9-c4f4-ab82-e063-6394a90aaa5c

Reported adverse events (FAERS/openFDA)#

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