VERTRA EHUKAI BEIGE FACE STICK SPF 38- titanium dioxide stick

Vertra Ehukai Beige Face Stick SPF 38 by

Drug Labeling and Warnings

Vertra Ehukai Beige 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

Vertra

38

Ehukai Beige Face Stick

Mineral Based Foundation

Broad Spectrum SPF 38

Water Resistant (80 minutes)

11g NET WT. 0.39 OZ

INGREDIENTS AND APPEARANCE

VERTRA EHUKAI BEIGE FACE STICK SPF 38 
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 66990-1020
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
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)
PARAFFIN (UNII: I9O0E3H2ZE)
STEARYL GLYCYRRHETINATE (UNII: 3YYE6VJS0P)
HEXYLDECYL ISOSTEARATE (UNII: 3V20TC06U5)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
TOCOPHEROL (UNII: R0ZB2556P8)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
STEARIC ACID (UNII: 4ELV7Z65AP)
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
POLYGLYCERYL-2 OLEATE (UNII: 5759J47SAM)
CERESIN (UNII: Q1LS2UJO3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66990-1020-1	11 g in 1 BOTTLE; 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 final	M020	12/18/2020

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

Establishment
Name	Address	ID/FEI	Business Operations
Toshiki Pigment Co., ltd.		716140285	manufacture(66990-1020)