Label: NAPLES COMPANY - SUNSCREEN BROAD SPECTRUM SPF 30 TINTED MINERAL FACE- titanium dioxide and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL

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
    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

    • 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 (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

  • 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 30

    30

    Tinted Mineral
    Face Cream

    2 fl oz (60mL)

    TINTED

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    NAPLES COMPANY - SUNSCREEN BROAD SPECTRUM SPF 30 TINTED MINERAL FACE 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-0602
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide7.75 g  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    ALUMINUM STEARATE (UNII: U6XF9NP8HM)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
    SQUALANE (UNII: GW89575KF9)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)  
    JOJOBA OIL (UNII: 724GKU717M)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SUCROSE STEARATE (UNII: 274KW0O50M)  
    PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    POLYGLYCERYL-2 CAPRATE (UNII: JX7WXJ41DH)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-0602-160 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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