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  5. Label Information: Translucent Broad Spectrum Foundation Spf 50 Vertra

FDA Label for Translucent Broad Spectrum Foundation Spf 50 Vertra

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. OTC - KEEP OUT OF REACH OF CHILDREN
    4. INDICATIONS & USAGE
    5. WARNINGS
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Translucent Broad Spectrum Foundation Spf 50 Vertra Product Label

The following document was submitted to the FDA by the labeler of this product Eai-jr286, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.


* Please review the disclaimer below.