Foundation Sunscreen Face Stick Broad Spectrum Spf 35 Cooly Beige
FDA Label NDC 71014-021

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 Foundation Sunscreen Face Stick Broad Spectrum Spf 35 Cooly Beige (NDC 71014-021). 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

Titanium Dioxide 23%           Sunscreen

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 chilcren. 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

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
  • immediately after towel drying
  • at leasty 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 15 or higher and other 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 Isostearate, 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 Premium Suncare

Foundation
Sunscreen Face Stick
Broad Spectrum SPF 35
Water Resistant (80 minutes)

Color: Cooly Beige

11g NET WT. .39 OZ.

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