Translucent Broad Spectrum Foundation Spf 50
FDA Label NDC 71014-005

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Eai-jr286, Inc. for the product Translucent Broad Spectrum Foundation Spf 50 (NDC 71014-005). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                       Purpose

Padamite O 7%                             Sunscreen

Titanium Dioxide 17%

Otc - 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

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

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

Warnings

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

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

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.

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