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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. USES
    4. WARNINGS
    5. OTC - DO NOT USE
    6. OTC - WHEN USING
    7. OTC - ASK DOCTOR
    8. OTC - KEEP OUT OF REACH OF CHILDREN
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. OTC - QUESTIONS
    13. 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%, Octocrylene 6.0%


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 - 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



  • apply liberally 15 minutes before sun exposure
  • 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



water, cetearyl alcohol, stearyl alcohol, glycerin, acrylates/C12-22 alkyl methacrylate crosspolymer, cetyl alcohol, carbomer, ceteth-10 phosphate, dicetyl phosphate, coco-glucoside, xanthan gum, disodium EDTA, methyl dihydroabietate, lauryl PEG-8 dimethicone, phenylisopropyl dimethicone, polyglyceryl-3 stearate/isostearate/dimer dilinoleate crosspolymer, sodium ascorbyl phosphate, tocopheryl acetate, aloe barbadensis leaf juice, phenoxyethanol, triethanolamine, propylene glycol, hydroxyacetophenone.


Otc - Questions



Toll-Free 800 225 8238

Int'l +1 651 642 9889


Package Label.Principal Display Panel



Tenacious Ergodyne KREWD SPF 50 Lotion

8 FL OZ (237mL)

NDC 73620-001-11

Label - 73620 001 11

Label - 73620 001 11

Tenacious Ergodyne KREWD SPF 50 Lotion

1.5 FL OZ (44mL)

NDC 73620-001-49

Tenacious Ergodyne KREWD SPF 50 Lotion

32 FL OZ (946mL)

NDC 73620-001-72


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