Naples Company - Sunscreen Broad Spectrum Spf 30 Tinted Mineral Face
FDA Label NDC 66163-0602

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Solutions Llc for the product Naples Company - Sunscreen Broad Spectrum Spf 30 Tinted Mineral Face (NDC 66163-0602). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by: Naples Soap Company • Naples, FL 33913

Otc - Purpose

Active IngredientsPurpose
Titanium Dioxide (7.75%)Sunscreen
Zinc Oxide (10.0%)Sunscreen

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

Warnings

For external use only

Otc - Do Not Use

  • Do not use on damaged or broken skin

Otc - When Using

  • When using this product keep out of eyes
  • Rinse with water to remove

Otc - Stop Use

  • Stop use and ask a doctor if rash occurs

Otc - Keep Out Of Reach Of Children

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

Directions

  • 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

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

Protect this product from excessive heat and direct sunlight

Questions Or Comments?

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

Principal Display Panel - 60 Ml Bottle Label

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)

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