FDA.reportPublic FDA data

Dr Edward Krulig New Melan Sunblock SPF 50

Manufacturer
KRULIG INTERNATIONAL, INC
Effective date
2024-10-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:31:50

Label at a glance#

ProductDr Edward Krulig New Melan Sunblock SPF 50
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE
Label structure8 sections

Indications and 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

Dosage and administration

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. T...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 10.00%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • rash or irritation develops and lasts.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84857-545-00Dr Edward Krulig New Melan Sunblock SPF 50100 mL in 1 BOTTLELIQUID1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84857-545DR EDWARD KRULIG NEW MELAN SUNBLOCK SPF 50 (AVOBENZONE, OCTISALATE, OCTOCRYLENE) LIQUID [KRULIG INTERNATIONAL, INC]1Current NDC, 1 package rows20241101_21c301d2-b283-40e1-bf26-b4bdde278247.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84857-54584857-545-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ASCORBYL PALMITATEQN83US2B0NIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
CHAMOMILEFGL3685T2XIACT
CUCUMBERYY7C30VXJTIACT
HELIANTHUS ANNUUS FLOWERING TOPBKJ0J3D1BPIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Edward Krulig New Melan Sunblock SPF 50AVOBENZONE, OCTISALATE, OCTOCRYLENEKRULIG INTERNATIONAL, INC21c301d2-b283-40e1-bf26-b4bdde2782472024-10-31WarningsExact identifier
ndc (package): 84857-545-00
ndc (product): 84857-545
ndc11 (package): 84857054500
spl id: 25c22608-ce97-dd0c-e063-6394a90a3a97
spl set id: 21c301d2-b283-40e1-bf26-b4bdde278247

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.