Dr Edward Krulig New Melan Sunblock Spf 50 Liquid
FDA Label NDC 84857-545

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Krulig International, Inc for the product Dr Edward Krulig New Melan Sunblock Spf 50 (NDC 84857-545). 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 drug facts, active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 10.00%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn.
  • Higher SPF gives more sunburn protection
  • Retains SPF after 80 minutes of swimming or sweating
  • 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

Do Not Use

  • on damaged or broken skin.

When Using This Product

  • keep out of eyes.Rinse with water to remove.
  • Do not puncture or incinerate. Contents under pressure.

    • Do not store it at temperatures above 120°F.

Stop Use And Ask A Doctor If

  • rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

ask a health professional before use

Directions

  • Apply liberally 15 minutes before sun exposure and as
  • needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • do not spray directly on face. Spray into hands and apply to face.
  • Use in well-ventilated areas
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF 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.

Inactive Ingredients

Acrylates/Octylacrylamide Copolymer, Aloe Barbadensis Leaf (Aloe Vera) Extract, Ascorbyl Palmitate (Vitamin C), Butyloctyl Salicylate, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), SD-Alcohol 40B, Tocopheryl Acetate (Vitamin E).

Questions?

+34 645 66 06 12 For Europe
+1 954 914 5722 For America

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