Vertra SPF 50 Foundation Sunscreen Face Translucent

Dosage form: stick
Ingredients: TITANIUM DIOXIDE 17.4g in 100g, PADIMATE O 7g in 100g
Labeler: Vertra, Inc
NDC Code: 43458-1003

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.

Vertra SPF 50 Foundation Sunscreen Face Stick Translucent

Drug Facts


Active Ingredients

TITANIUM DIOXIDE  17.4%
PADIMATE O  7%

Purpose

Sunscreen

Uses
  • Helps prevent sunburn
  • For skin highly sensitive to sunburn
  • Higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes of activity in water

Skin Cancer/Skin Aging Alert:

If used as directed with other skin protection measures (see directions), this product decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings:
  • For external use only

Do not use

on damaged or broken skin.

Stop use

and ask a doctor if rash occurs.

When using this product
  • Keep out of eyes, Rinse with water to remove.

Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center immediately.

Directions:
  • Apply liberally 15 minutes before sun exposure.  Blend into skin with finger or applicator if necessary.
  • Reapply: after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Children under 6 months of age: ask a doctor

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 other sun protection measures including:
  • limit time in the sun, especially from 10 am to 2 pm.
  • wear long sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

HEXYLDECYL ISOSTEARATE, MICA, SYNTHETIC WAX, OZOKERITE, PARAFFIN,  POLYGLYCERYL-2 OLEATE,  ALUMINUM HYDROXIDE, STEARIC ACID, ETHYLENE/PROPYLENE COPOLYMER, TOCOPHEROL, BUTYLPARABEN, PROPYLPARABEN, FRAGRANCE

Vertra ELEMENTAL RESISTANCE

This foundation based sunscreen was developed with only the most serious athlete in mind.  The ultimate protection against skin-aging UVA rays and skin-burning UVB rays.  This natural beige formula blends smoothly into the skin.  The added color not only serves as a physical block but it provides the wearer with visible reassurance that the product is still active.

  • Water Resistant (80 minutes)
  • Smooth, Non-Greasy application
  • The Skin Cancer Foundation recommends this product as an effective UV Sunscreen.  For more information visit:  www.skincancer.org

Ventra ELEMENTAL RESISTANCE  SPF 50+  FOUNDATION SUNSCREEN FACE STICK  COLOR:TRANSLUCENT  BROAD SPECTRUM UVA/UVB PROTECTION  WATER RESISTANT (80 MINUTES)  10.5g  NET WT. .37 OZ.   www.ventra.com  Ventral Elemental Resistance is proud to be the Official Suncare provider for the Hawaiian Lifeguard Association  

TRANSLUCENT SPF 50+   DIST. BY:  VERTRA INC.  HONOLULU, HI 96813   MADE IN JAPAN

Vertra SPF 50+ Foundation Sunscreen Face Stick Translucent 10.5g (43458-1003-9)

VERTRA SPF 50 FOUNDATION SUNSCREEN FACE TRANSLUCENT 
titanium dioxide, padimate o stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43458-1003
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE17.4 g  in 100 g
PADIMATE O (PADIMATE O) PADIMATE O7 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MICA 
SYNTHETIC WAX (1200 MW) 
CERESIN 
PARAFFIN 
ALUMINUM HYDROXIDE 
STEARIC ACID 
TOCOPHEROL 
BUTYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:43458-1003-910.5 g in 1 DIALPACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/08/2012
Labeler - Vertra, Inc (930280362)
Establishment
NameAddressID/FEIOperations
Toshiki Pigment Company Limited690723812manufacture

Revised: 07/2012
 
Vertra, Inc

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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