Translucent Broad Spectrum Foundation SPF 50 Vertra: Package Insert and Label Information

TRANSLUCENT BROAD SPECTRUM FOUNDATION SPF 50 VERTRA- padimate o and titanium dioxide stick
Eai-Jr286, Inc.

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

Padamite O 7% Sunscreen

Titanium Dioxide 17%

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. If products is swallowed, get medical help or contact Poison Control Center right away.

Stop use and ask a doctor if rash or irritation develops and lasts

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

Directions

• apply liberally and evenly 15 minutes before sun exposure
• apply to all skin exposed to sun
• use a water resistant sunscreen if swimming or sweating
• reapply: after 80 minutes of swimming or sweating
• immeadiately after towel drying
• 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 otther sun protection measures including:
• limit time in the sun, especially from 10 a.m. — 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses
• children under 6 months of age: ask a doctor

Hexyldecyl Isosterate, Mica, Synthetic wax, Paraffin, Ozokerite, Polyglyceryl-2 Oleate, Aluminum Hydroxide, Stearic Acid, Ethylene/Propylene Copolymer, Tocopheryl, Fragrance, Iron Oxides

Vertra Elemental Resistance

Foundation

Sunscreen Face Stick

Broad Spectrum SPF 50+

Water Resistant (80 minutes)

Color: Translucent

10.5g NET WT. .37 oz.

TRANSLUCENT BROAD SPECTRUM FOUNDATION SPF 50 VERTRA padimate o, titanium dioxide stick

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71014-005 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 17.45 g in 100 g

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

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:71014-005-02 1 CYLINDER in 1 BOX contains a CYLINDER (71014-005-01) 1 NDC:71014-005-01 10.5 g in 1 CYLINDER This package is contained within the BOX (71014-005-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 10/07/2016

Labeler — Eai-Jr286, Inc. (827896718)

Registrant — Eai-Jr286, Inc. (827896718)

Establishment
Name	Address	ID/FEI	Operations
Toshiki Pigment Co., ltd.		716140285	manufacture (71014-005)

Revised: 01/2020 Eai-Jr286, Inc.