Vertra Pearl White Face Stick SPF 50: Package Insert and Label Information

VERTRA PEARL WHITE FACE STICK SPF 50- padimate o and titanium dioxide stick
Toshiki Pigment Co., ltd.

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.

Active Ingredients Purpose

PADIMATE O 7% Sunscreen

TITANIUM DIOXIDE 17% Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection (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:

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

Stop use and ask a doctor if:

Rash or irritation develops and lasts

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

Directions

• Apply liberally and generously 15 minutes before sun exposure and at least every 2 hours
• Children under 6 months of age: ask a doctor.
• 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
• Reapply:
• After 80 minutes of swimming or sweating
• Immediately after towel drying
• at least every 2 hours

Inactive Ingredients

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

Vertra

Premium Suncare

SPF 50 +

Premium Mineral Based

Foundation Sunscreen

Face Stick

Reef Safe

Broad Spectrum SPF 50+

Water Resistant (80 Minutes)

Color: Pearl white

10.5g NET WT 0.37 OZ

VERTRA PEARL WHITE FACE STICK SPF 50 padimate o, titanium dioxide stick

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66990-1019 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PADIMATE O (PADIMATE O) PADIMATE O 7 g in 100 g TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 17 g in 100 g

Inactive Ingredients Ingredient Name Strength TOCOPHEROL PARAFFIN HEXYLDECYL ISOSTEARATE SYNTHETIC WAX (1200 MW) POLYGLYCERYL-2 OLEATE ALUMINUM HYDROXIDE MICA CERESIN STEARIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:66990-1019-1 10.5 g in 1 CARTON None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 12/16/2020

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

Establishment
Name	Address	ID/FEI	Operations
Toshiki Pigment Co., ltd.		716140285	manufacture (66990-1019)

Revised: 10/2022 Toshiki Pigment Co., ltd.