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  5. Label Information: Tenacious Ergodyne

FDA Label for Tenacious Ergodyne

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENTS
    2. PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. FLAMMABLE:
    6. OTC - DO NOT USE
    7. OTC - WHEN USING
    8. OTC - ASK DOCTOR
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. OTC - QUESTIONS
    14. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tenacious Ergodyne Product Label

The following document was submitted to the FDA by the labeler of this product Tenacious Holdings, 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.

Active Ingredients



Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0%, Octocrylene 4.0%


Purpose



Sunscreen


Indications & Usage



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


Flammable:



  • do not use near heat, flame or while smoking
  • avoid long term storage above 104°F (40°C)

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. • keep away from face to avoid breathing it. • do not puncture or incinerate. Contents under pressures. • do not store at temperatures above 120°F.


Otc - Ask Doctor



Stop use and ask a doctor if • rash occurs.


Otc - Keep Out Of Reach Of Children



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


Directions



  • Spray liberally and spready evenly by hand 15 minutes before sun exposure
  • Hold can 4-6 inches away from the skin to apply
  • Do not spray directly into face. Spray into hands then apply to face
  • Do not apply in windy conditions
  • Use in a well-ventilated area
  • 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 a.m.-2 p.m.

         • wear long-sleeved shirts, pants, hats, and sunglasses


Other Information



  • protect the product in this container from excessive heat and direct sun
  • may stain or damage some fabrics, materials or surfaces

Inactive Ingredients



alcohol denat., butyloctyl salicylate, acrylates/octylacrylamide copolymer, panthenol, tocopherol (vitamin E), fragrance, stearoxytrimethylsilane, caprylic/capric triglyceride, glycerin


Otc - Questions



TOLL-FREE 800 225 8238 // INT'L +1 651 642 9889


Package Label.Principal Display Panel



Tenaciuos Ergodyne KREWD SPF 50 Continuous Spray

5.5 OZ (156g)

NDC 73620-002-37

Label - 73620 002 37

Label - 73620 002 37


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