NAPLES COMPANY - SUNSCREEN BROAD SPECTRUM SPF 30 TINTED MINERAL FACE- titanium dioxide and zinc oxide cream 
Cosmetic Solutions LLC

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.

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Naples Soap Company - Sunscreen Broad Spectrum SPF 30 Tinted Mineral Face Cream

Drug Facts

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

Uses

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

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

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
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)

Revised: 6/2022
Document Id: 098c9da9-d89b-4bdc-ae44-dbe38fbef451
Set id: 88423947-3d7f-4f32-a7ad-25b1aa71197e
Version: 1
Effective Time: 20220607
 
Cosmetic Solutions LLC