Naples Company - Sunscreen Broad Spectrum Spf 25 Lightweight Face
FDA Label NDC 66163-2603

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 25 Lightweight Face (NDC 66163-2603). 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, otc - keep out of reach of children, directions, inactive ingredients, other information, questions or comments?, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

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

    • Distributed by: Naples Soap Company • Naples, FL 33913

Otc - Purpose

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

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, 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

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 25

25

Lightweight
Face Cream

2 fl oz (60mL)

Principal Display Panel (60 mL Bottle Label)

Principal Display Panel (60 mL Bottle Label)

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