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  5. Label Information: Vertra Elemental Resistance Water Resistant Sunscreen

FDA Label for Vertra Elemental Resistance Water Resistant Sunscreen

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - STOP USE
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. DESCRIPTION
    14. PRINCIPAL DISPLAY PANEL

Vertra Elemental Resistance Water Resistant Sunscreen Product Label

The following document was submitted to the FDA by the labeler of this product Vertra (aust) Pty Ltd. 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.

Active Ingredients



Octyl Methoxycinnamate 6%
Oxybenzone 5%
Titanium Dioxide 6.3%
Zinc Oxide 9.9%


Purpose



Sunscreen


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

Warnings



For external use only


Otc - Do Not Use



Do not use on damaged or broken skin


Otc - When Using



When using this product keep out of eyes - Rinse with water to remove.


Otc - Stop Use



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


Otc - Keep Out Of Reach Of Children



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


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 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 15 or higher and other sun protection measures including: limit time in the sun, especially from 10a.m.-2p.m., wear long-sleeve shirts, pants, hats, and sunglasses, children under 6 months of age: ask a doctor

Other Information



  • protect this product from excessive heat and direct sun

Inactive Ingredients



Acrylates copolymer, Ammonia, C12-15 alkyl benzoate, Cyclomethicone 5, Iodopropynl butylcarbamate, Lauryl PEG/PPG-18/18 methicone, Methyl glucose dioleate, Methlchloroisothiazolinone, Methylisothiazolinone, Phenoxyethanol, Phenyl trimethicone, Polyhydroxystearic acid, Purified water, Silica dimethyl silylate, Silicone dioxide, Sodium chloride, Sodium dodecylbenzenesulfonate, Stearic acid, Triethoxycaprylylsilane, Xanthan gum


Questions Or Comments?



Vertra Inc - 875 Waimanu St. #614A Honolulu, HI 96813 - 1(808)593-8378 www.vertra.com


Description



Vertra Elemental Resistance is proud to be the Official Suncare provider for the Hawaiian Lifeguard Association

Distributed by: Vertra Inc. Honolulu, HI 96813
Made in Australia
www.vertra.com


Principal Display Panel



Vertra Elemental Resistance

50+ SUNPROTECTIONCREAM
BROAD SPECTRUM SPF50+
UVA/UVB Protection
WATER RESISTANT (80 MINUTES) SUNSCREEN

Net. Wt. 2.8 oz (80 g)

Vertra Label - VertraLabel

Vertra Label - VertraLabel



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