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

Naples Company - Sunscreen Broad Spectrum SPF 30 Tinted Mineral Face by

Drug Labeling and Warnings

Naples Company - Sunscreen Broad Spectrum SPF 30 Tinted Mineral Face by is a Otc medication manufactured, distributed, or labeled by Cosmetic Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active Ingredients	Purpose
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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66163-0602
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	7.75 g  in 100 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66163-0602-1	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	07/01/2022

Labeler - Cosmetic Solutions LLC (807907928)