SPF 50 FLORIDA SUN DEFENSE BROAD SPECTRUM SPF 50 SUNSCREEN BODY OIL- homosalate, octisalate, octocrylene oil

SPF 50 Florida Sun Defense by

Drug Labeling and Warnings

SPF 50 Florida Sun Defense 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

Drug Facts

Active ingredients

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Purpose

Sunscreen

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

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 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

• Protect the product in this container from excessive heat and direct sun

Inactive ingredients

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?

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

PRINCIPAL DISPLAY PANEL - 100 ML CARTON LABEL

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

INGREDIENTS AND APPEARANCE

SPF 50 FLORIDA SUN DEFENSE  BROAD SPECTRUM SPF 50 SUNSCREEN BODY OIL
homosalate, octisalate, octocrylene oil

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84489-100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
POLYAMIDE-3 (20000 MW) (UNII: PLF06VZ9SQ)
OCTYLDODECANOL (UNII: 461N1O614Y)
BUTYROSPERMUM PARKII (SHEA) BUTTER (UNII: K49155WL9Y)
LAURYL LACTATE (UNII: G5SU0BFK7O)
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)
GRAPE SEED OIL (UNII: 930MLC8XGG)
LIMNANTHES ALBA (MEADOWFOAM) SEED OIL (UNII: 412ZHA4T4Y)
HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL (UNII: 3W1JG795YI)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
CUCUMBER (UNII: YY7C30VXJT)
CITRIC ACID (UNII: 2968PHW8QP)
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)
DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
TOCOPHEROL (UNII: R0ZB2556P8)
RAPHANUS SATIVUS VAR. SATIVUS SEED (UNII: A94I086Q5E)
COCOS NUCIFERA (COCONUT) OIL (UNII: Q9L0O73W7L)
ARGANIA SPINOSA KERNEL OIL (UNII: 4V59G5UW9X)
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84489-100-34	1 in 1 CARTON	07/03/2025
1		100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	07/03/2025

Labeler - Naples Soap Company, Inc. (052273536)