Label: NAPLES COMPANY - SUNSCREEN BROAD SPECTRUM SPF 25 LIGHTWEIGHT FACE- octinoxate and zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated June 7, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    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
  • Warnings

    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

    • 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

  • SPL UNCLASSIFIED SECTION

    Distributed by: Naples Soap Company • Naples, FL 33913

  • 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
  • INGREDIENTS AND APPEARANCE
    NAPLES COMPANY - SUNSCREEN BROAD SPECTRUM SPF 25 LIGHTWEIGHT FACE 
    octinoxate and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-2603
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51) Octinoxate7 g  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide6 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isocetyl Stearate (UNII: 3RJ7186O9W)  
    Sorbitol (UNII: 506T60A25R)  
    Ethyl Macadamiate (UNII: ANA2NCS6V1)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Dimethicone (UNII: 92RU3N3Y1O)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    Glycerin (UNII: PDC6A3C0OX)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    Octisalate (UNII: 4X49Y0596W)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Lingonberry (UNII: 0UNK9RZQ7X)  
    Quercus Suber Bark (UNII: 8R5219271Q)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Green Tea Leaf (UNII: W2ZU1RY8B0)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Centella Asiatica Whole (UNII: 7M867G6T1U)  
    Polygonum Aviculare Top (UNII: ZCD6009IUF)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Gluconolactone (UNII: WQ29KQ9POT)  
    Isomalt (UNII: S870P55O2W)  
    Calcium Gluconate (UNII: SQE6VB453K)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Garden Cress Sprout (UNII: PWQ18YNR62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-2603-160 mL in 1 BOTTLE; Type 0: Not a Combination Product07/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35207/01/2022
    Labeler - Cosmetic Solutions LLC (807907928)
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