SPL v1
SPL
SPL Set ID 47c147a9-c4f4-ab82-e063-6394a90aaa5c
Route
TOPICAL
Published
Effective Date 2025-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (10 g) Homosalate (5 g) Octisalate
Inactive Ingredients
Polyamide-3 (20000 Mw) Octyldodecanol Butyrospermum Parkii (shea) Butter Lauryl Lactate Diethylhexyl Syringylidenemalonate Grape Seed Oil Limnanthes Alba (meadowfoam) Seed Oil Helianthus Annuus (sunflower) Seed Oil Butyloctyl Salicylate Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Cucumber Citric Acid C12-15 Alkyl Benzoate Diisopropyl Sebacate Tocopherol Raphanus Sativus Var. Sativus Seed Cocos Nucifera (coconut) Oil Argania Spinosa Kernel Oil Camellia Sinensis Whole

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-03
Description

Drug Facts

Purpose

Sunscreen

Medication Information

Purpose

Sunscreen

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • rash occurs
Section 50567-7

When using this product

  • keep out of eyes. Rinse with water to remove.
Section 50570-1

Do not use

  • ​on damaged or broken skin
Warnings

For external use only

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
Active Ingredients

Homosalate 10%

Octisalate 5%

Octocrylene 10%

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 [email protected]

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

Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • rash occurs
Section 50567-7 (50567-7)

When using this product

  • keep out of eyes. Rinse with water to remove.
Section 50570-1 (50570-1)

Do not use

  • ​on damaged or broken skin
Purpose

Sunscreen

Warnings

For external use only

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 (Other information)
  • Protect the product in this container from excessive heat and direct sun
Active Ingredients (Active ingredients)

Homosalate 10%

Octisalate 5%

Octocrylene 10%

Inactive Ingredients (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? (Questions or Comments?)

Call (239) 325-8263 or email [email protected]

Principal Display Panel 100 Ml Carton Label (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:08:28.101531 · Updated: 2026-03-14T23:12:40.778283