DR EDWARD KRULIG NEW MELAN SUNBLOCK SPF 50- avobenzone, octisalate, octocrylene liquid

Dr Edward Krulig New Melan Sunblock SPF 50 by

Drug Labeling and Warnings

Dr Edward Krulig New Melan Sunblock SPF 50 by is a Otc medication manufactured, distributed, or labeled by KRULIG INTERNATIONAL, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Package Labeling:

INGREDIENTS AND APPEARANCE

DR EDWARD KRULIG NEW MELAN SUNBLOCK SPF 50 
avobenzone, octisalate, octocrylene liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84857-545
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
CHAMOMILE (UNII: FGL3685T2X)
CUCUMBER (UNII: YY7C30VXJT)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84857-545-00	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/14/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/14/2024

Labeler - KRULIG INTERNATIONAL, INC (131652883)