Vertra Elemental Resistance
FDA Label NDC 69750-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Vertra (aust) Pty Ltd for the product Vertra Elemental Resistance (NDC 69750-001). 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 active ingredients, purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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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