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  5. Label Information: Pyratine Xr Creme With Sunscreen Broad Spectrum Spf30

FDA Label for Pyratine Xr Creme With Sunscreen Broad Spectrum Spf30

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - WHEN USING
    6. OTC - STOP USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DOSAGE & ADMINISTRATION
    9. OTHER SAFETY INFORMATION
    10. OTC - QUESTIONS
    11. STORAGE AND HANDLING
    12. INACTIVE INGREDIENT
    13. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pyratine Xr Creme With Sunscreen Broad Spectrum Spf30 Product Label

The following document was submitted to the FDA by the labeler of this product Allure Labs 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.

Otc - Active Ingredient



Active Ingredient: Zinc oxide - 18.6%


Otc - Purpose



Purpose: Sunscreen


Indications & Usage



Uses:

  • Help prevent sunburn. Higher SPF gives more sunburn protection. Provide high protection against 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



Warnings: For external use only. 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 developes and lasts.


Otc - Keep Out Of Reach Of Children



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


Dosage & Administration



Directions:

  • For sunscreen use. Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating.
  • 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 protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirts, pants, hats, and sunglasses. Children under 6 months of age: Ask a doctor.

Other Safety Information



protect this product from excessive heat and direct sun.


Otc - Questions



Call toll free 1-888-467-9728


Storage And Handling



Store at controlled room temperature 59 F - 89 F (15 C - 30 C).


Inactive Ingredient



Inactive Ingredients: Water (Aqua), Cyclopentasiloxane, Butylene glycol, glycerin, Propylene Glycol, Caprylic/Capric triglyceride, Glycerin Stearate, PEG-100 Stearate, Polyglyceryl-3 Polymethylsiloxyeethyl Dimethicon, Cyclohexasiloxane, Sorbitan Stearate, Dimethicone, Polyacrylamide, C13-14 Isoparaffin, Laureth-7,phenoxyethanol, Caprylyl Glycol, Ethylhexyglycerin, Hexylene glycol, Imperata Cylindrica Root Extract, PEG-8, Carbomer, triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Cetyl Alcohol, Lecithin, Tocopherol, Ascorbyl Palmitate, Ascorbic Acid, Citric Acid, Xanthan gum, Furfuryl Tetrahydropyranyladinine, tocopherol Linoleate/Oleate, Teprenone, Phoenix Dactylifera (Date) Fruit Extract, Sodium Lactate, Disodium EDTA, Dipotassium Glycyrrhizate, Arabidopsis Thaliana Extract, Plankton Extract and Micrococcus Lysate.


Package Label.Principal Display Panel



Developed, Distributed and Marketed by:

Pyratine LLC

2950 Main Street

Morro Bay, CA 93442

1-888-467-9728

www.pyratine.com


* Please review the disclaimer below.