VERTRA S DORIAN KONA GOLD SIGNATURE FACE STICK SPF 38- titanium dioxide stick

Vertra S Dorian Kona Gold Signature Face Stick SPF 38 by

Drug Labeling and Warnings

Vertra S Dorian Kona Gold Signature Face Stick SPF 38 by is a Otc medication manufactured, distributed, or labeled by Toshiki Pigment Co., ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients Purpose

TITANIUM DIOXIDE 23% Sunscreen

PURPOSE

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
• Higher SPF gives more sunburn protection.
• Retains SPF after 80 minutes activity in the water, sweating, or perspiring
• Provides high protection against sunburn

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children:

• If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Stop use and ask a doctor if:

• Rash or irritation develops and lasts

WARNINGS

Warnings

Do not use:

• On damaged or broken skin

When using this product:

• Keep out of eyes. RInse with water to remove.

For external use only

DOSAGE & ADMINISTRATION

Directions

Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours and at least every 2 hours.

Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun
protection measures including:

limit your time in the sun, especially from 10 a.m. – 2 p.m.

wear long-sleeved shirts, pants, hats, and sunglasses

Children under 6 months of age: ask a doctor

Reapply:

After 80 minutes of swimming or sweating
Immediately after towel drying
At least every 2 hours

INACTIVE INGREDIENT

Inactive Ingredients

Hexyldecyl Isostearate, Aluminum Hydroxide, Mica, Iron Oxides, Stearic Acid, Paraffin, Ozokerite, Synthetic Wax, Ethylene/Propylene Copolymer, Polyglyceryl-2 Oleate, Tocopherol, Stearyl Glycyrrhetinate

PRINCIPAL DISPLAY PANEL

Kona Gold

vertra

38

Mineral Based Foundation

Broad Spectrum SPF 38

Water Resistant (80 minutes)

11g NET WT. 0.39 OZ

INGREDIENTS AND APPEARANCE

VERTRA S DORIAN KONA GOLD SIGNATURE FACE STICK SPF 38 
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66990-1021
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	23 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MICA (UNII: V8A1AW0880)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PARAFFIN (UNII: I9O0E3H2ZE)
CERESIN (UNII: Q1LS2UJO3A)
STEARIC ACID (UNII: 4ELV7Z65AP)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)
HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66990-1021-1	11 g in 1 CARTON; Type 0: Not a Combination Product	12/18/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/18/2020

Labeler - Toshiki Pigment Co., ltd. (716140285)