Translucent Broad Spectrum Foundation SPF 50

Manufacturer
Eai-Jr286, Inc. | Toshiki Pigment Co., ltd.
Effective date
2020-01-08
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 23:02:52

Label at a glance#

ProductTranslucent Broad Spectrum Foundation SPF 50 Vertra
Active ingredientPADIMATE O, TITANIUM DIOXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients                       Purpose

Padamite O 7%                             Sunscreen

Titanium Dioxide 17%

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If products is swallowed, get medical help or contact Poison Control Center right away.

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vertra Elemental Resistance

Foundation

Sunscreen Face Stick

Broad Spectrum SPF 50+

Water Resistant (80 minutes)

Color: Translucent

10.5g  NET WT. .37 oz.

Translucent SPF 50 updated boxTranslucent SPF 50 updated box

Translucent SPF 50 updated stickTranslucent SPF 50 updated stick

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71014-005-022023-01-30C16284748780-1f386c649-be48-0266-e053-dadaa90a7c1aVertra Elemental Resistance Broad Spectrum Foundation Face Screen SPF 50 - Translucent

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71014-005-01Translucent Broad Spectrum Foundation SPF 50Vertra10.5 g in 1 CYLINDERSTICK10.57
71014-005-02Translucent Broad Spectrum Foundation SPF 50Vertra1 in 1 BOXSTICK17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71014-005TRANSLUCENT BROAD SPECTRUM FOUNDATION SPF 50 VERTRA (PADIMATE O, TITANIUM DIOXIDE) STICK [EAI-JR286, INC.]7Legacy NDC, 2 package rows20200110_944f02dc-7b02-4eca-aa2b-b6416cf7bb80.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71014-00571014-005-01, 71014-005-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4e8d80c2-ebb5-4d11-a19e-95d2cf33dae8944f02dc-7b02-4eca-aa2b-b6416cf7bb802020-01-08WarningsExact identifier
spl id: 4e8d80c2-ebb5-4d11-a19e-95d2cf33dae8
spl set id: 944f02dc-7b02-4eca-aa2b-b6416cf7bb80

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.