FDA.reportPublic FDA data

Naples Soap Company - Sunscreen Broad Spectrum SPF 30 Tinted Mineral 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 30 Tinted Mineral Face
Active ingredientTitanium Dioxide, 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
Titanium Dioxide (7.75%)Sunscreen
Zinc Oxide (10.0%)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

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 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 (Aqua), Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Glycerin, Dimethicone, Styrene/Acrylates Copolymer,Coco-Caprylate/ Caprate, Aluminum Stearate, Carthamus Tinctorius Oleosomes, Polyhydroxystearic Acid, Aloe (Aloe Barbadensis) Leaf Juice, Knotweed (Polygonum Aviculare) Extract, Tocopheryl Acetate, Perilla (Perilla Frutescens) Extract, Grape (Vitis Vinifera) Fruit Cell Extract, Garden Cress (Lepidium Sativum) Sprout Extract, Squalane, Cetearyl Alcohol, Isononyl Isononanoate, Coco-Glucoside, Pentylene Glycol, Behenyl Alcohol, Xanthan Gum, Triethoxycaprylylsilane, Arachidyl Glucoside, Jojoba (Simmondsia Chinensis) Seed Oil, Stearic Acid, Sucrose Stearate, Phenethyl Alcohol, Tetrahexyldecyl Ascorbate, Glyceryl Caprylate, Ethylene/Propylene/Styrene Copolymer, Sorbitan Oleate, Polyglyceryl-2 Caprate, Propanediol, Alumina, Arachidyl Alcohol, Iron Oxides (CI 77492, CI 77491, CI 77499)

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 30

30

Tinted Mineral
Face Cream

2 fl oz (60mL)

TINTED

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66163-0602-12024-01-30C16284748780-11030e365-3941-111a-e063-dadaa90a10e2Naples Soap Company - Sunscreen Broad Spectrum SPF 30 Tinted Mineral Face Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66163-0602-1Naples Company - Sunscreen Broad Spectrum SPF 30 Tinted Mineral Face60 mL in 1 BOTTLECREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66163-0602NAPLES COMPANY - SUNSCREEN BROAD SPECTRUM SPF 30 TINTED MINERAL FACE (TITANIUM DIOXIDE AND ZINC OXIDE) CREAM [COSMETIC SOLUTIONS LLC]1Legacy NDC, 1 package rows20220702_88423947-3d7f-4f32-a7ad-25b1aa71197e.zip

Products#

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

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66163-060266163-0602-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Name, UNII, Kind table
NameUNIIKind
Titanium Dioxide15FIX9V2JPACTIB
Zinc OxideSOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
ALUMINUM STEARATEU6XF9NP8HMIACT
CARTHAMUS TINCTORIUS SEED OLEOSOMES9S60Q72309IACT
ALOE VERA LEAFZY81Z83H0XIACT
POLYGONUM AVICULARE TOPZCD6009IUFIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GARDEN CRESS SPROUTPWQ18YNR62IACT
SQUALANEGW89575KF9IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
COCO GLUCOSIDEICS790225BIACT
PENTYLENE GLYCOL50C1307PZGIACT
DOCOSANOL9G1OE216XYIACT
XANTHAN GUMTTV12P4NEEIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
JOJOBA OIL724GKU717MIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSE STEARATE274KW0O50MIACT
PHENYLETHYL ALCOHOLML9LGA7468IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
POLYGLYCERYL-2 CAPRATEJX7WXJ41DHIACT
PROPANEDIOL5965N8W85TIACT
ALUMINUM OXIDELMI26O6933IACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT

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
098c9da9-d89b-4bdc-ae44-dbe38fbef45188423947-3d7f-4f32-a7ad-25b1aa71197e2022-06-07WarningsExact identifier
spl id: 098c9da9-d89b-4bdc-ae44-dbe38fbef451
spl set id: 88423947-3d7f-4f32-a7ad-25b1aa71197e

Reported adverse events (FAERS/openFDA)#

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