FDA.reportPublic FDA data

Naples Soap Company - Sunscreen Broad Spectrum SPF 25 Lightweight Face Cream

Manufacturer
Cosmetic Solutions LLC
Effective date
2022-06-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:02

Label at a glance#

ProductNaples Company - Sunscreen Broad Spectrum SPF 25 Lightweight Face
Active ingredientOctinoxate, Zinc Oxide
Label structure10 sections

Indications and uses

Helps prevent sunburn If 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 to all skin exposed to the sun Apply liberally 15 minutes before sun exposure Reapply: After 2 hours of swimming or sweating Immediately after towel drying At least every 2 hours Sun Protection Measures. Spending time in the sun increases your risk of skin and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures includi...

Storage and handling

Protect this product from excessive heat and direct sunlight

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Octinoxate (7.0%)Sunscreen
Zinc Oxide (6.0%)Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If 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

SPL UNCLASSIFIED SECTION

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

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 to all skin exposed to the sun
  • Apply liberally 15 minutes before sun exposure
  • Reapply:
    • After 2 hours of swimming or sweating
    • Immediately after towel drying
    • At least every 2 hours
  • Sun Protection Measures. Spending time in the sun increases your risk of skin and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Isocetyl Stearate, Cetyl Dimethicone, Styrene/Acrylates Copolymer, Sorbitol, Ethyl Macadamiate, Cetearyl Alcohol, Dimethicone, Acrylates/Dimethicone Copolymer, Phenoxyethanol, Glyceryl Stearate, Glycerin, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, PEG-100 Stearate, Ceteareth-20, Ethylhexyl Salicylate, VP/Eicosene Copolymer, Xanthan Gum, Polymethyl Methacrylate, Caprylyl Glycol, Coconut (Cocos Nucifera) Oil, Ethylhexylglycerin, Vaccinium Vitis-Idaea Fruit Extract, Cork Oak (Quercus Suber) Bark Extract, Triethoxycaprylylsilane, Tea Plant (Camellia Sinensis) Leaf Extract, Disodium EDTA, Tocopheryl Acetate, Oak (Quercus) Root Extract, Gotu Kola (Centella Asiatica) Extract, Knotweed (Polygonum Aviculare) Extract, Citric Acid, Gluconolactone, Isomalt, Calcium Gluconate, Lecithin, Grape (Vitis Vinifera) Fruit Cell Extract, Sodium Benzoate, Garden Cress (Lepidium Sativum) Sprout Extract

Other Information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sunlight

Questions or Comments?

OTC - QUESTIONS SECTION

Questions? 1-888-256-8265 or visit www.naplessoap.com

SPL UNCLASSIFIED SECTION

Distributed by: Naples Soap Company • Naples, FL 33913

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NAPLES
SOAP COMPANY

NATURALLY BETTER
SKIN CARE

SUNSCREEN

Broad Spectrum SPF 25

25

Lightweight
Face Cream

2 fl oz (60mL)

PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-2603-12024-01-30C16284748780-11030e365-2c34-111a-e063-dadaa90a10e2Naples Soap Company - Sunscreen Broad Spectrum SPF 25 Lightweight Face Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-2603-1Naples Company - Sunscreen Broad Spectrum SPF 25 Lightweight Face60 mL in 1 BOTTLELOTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-2603NAPLES COMPANY - SUNSCREEN BROAD SPECTRUM SPF 25 LIGHTWEIGHT FACE (OCTINOXATE AND ZINC OXIDE) LOTION [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20220702_5fa4b36d-b6c6-4cbc-937c-b15cfced6646.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-260366163-2603-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octinoxate4Y5P7MUD51ACTIB
Zinc OxideSOI2LOH54ZACTIB
Water059QF0KO0RIACT
Isocetyl Stearate3RJ7186O9WIACT
Sorbitol506T60A25RIACT
Ethyl MacadamiateANA2NCS6V1IACT
Cetostearyl Alcohol2DMT128M1SIACT
Dimethicone92RU3N3Y1OIACT
PhenoxyethanolHIE492ZZ3TIACT
Glyceryl Monostearate230OU9XXE4IACT
GlycerinPDC6A3C0OXIACT
Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%)86FQE96TZ4IACT
PEG-100 StearateYD01N1999RIACT
Polyoxyl 20 Cetostearyl EtherYRC528SWUYIACT
Octisalate4X49Y0596WIACT
Xanthan GumTTV12P4NEEIACT
Poly(Methyl Methacrylate; 450000 MW)Z47NNT4J11IACT
Caprylyl Glycol00YIU5438UIACT
Ethylhexylglycerin147D247K3PIACT
Lingonberry0UNK9RZQ7XIACT
Quercus Suber Bark8R5219271QIACT
TriethoxycaprylylsilaneLDC331P08EIACT
Green Tea LeafW2ZU1RY8B0IACT
Edetate Disodium Anhydrous8NLQ36F6MMIACT
.Alpha.-Tocopherol Acetate9E8X80D2L0IACT
Centella Asiatica Whole7M867G6T1UIACT
Polygonum Aviculare TopZCD6009IUFIACT
Citric Acid Monohydrate2968PHW8QPIACT
GluconolactoneWQ29KQ9POTIACT
IsomaltS870P55O2WIACT
Calcium GluconateSQE6VB453KIACT
Sodium BenzoateOJ245FE5EUIACT
Garden Cress SproutPWQ18YNR62IACT

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
73fb339e-9c41-4682-9b7a-0e925955d5995fa4b36d-b6c6-4cbc-937c-b15cfced66462022-06-07WarningsExact identifier
spl id: 73fb339e-9c41-4682-9b7a-0e925955d599
spl set id: 5fa4b36d-b6c6-4cbc-937c-b15cfced6646

Reported adverse events (FAERS/openFDA)#

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