Dr. Edward Krulig New Melan Sunblock Spf 50

Dr. Edward Krulig New Melan Sunblock Spf 50
SPL v1
SPL
SPL Set ID 21c301d2-b283-40e1-bf26-b4bdde278247
Route
TOPICAL
Published
Effective Date 2024-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Ethylhexyl Salicylate (50 mg) Octocrylene (100 mg)
Inactive Ingredients
Aloe Vera Leaf Ascorbyl Palmitate Butyloctyl Salicylate Chamomile Cucumber Helianthus Annuus Flowering Top .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-14

Description

Avobenzone 3.00% Octisalate 5.00% Octocrylene 10.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00% Octisalate 5.00% Octocrylene 10.00%

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

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
Do Not Use
  • on damaged or broken skin.
Drug Facts

Questions?

+34 645 66 06 12 For Europe

+1 954 914 5722 For America

Active Ingredient

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 10.00%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

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).

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.
If Pregnant Or Breast Feeding,

ask a health professional before use

Keep Out of Reach of Children.

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


Structured Label Content

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
Purpose

Sunscreen

Warnings

For external use only

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
Do Not Use (Do not use)
  • on damaged or broken skin.
Drug Facts

Questions?

+34 645 66 06 12 For Europe

+1 954 914 5722 For America

Active Ingredient

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 10.00%

Other Information
  • Protect the product in this container from excessive heat and direct sun.
Package Labeling:

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).

When Using This Product (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 (Stop use and ask a doctor if)
  • rash or irritation develops and lasts.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use

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.


Advanced Ingredient Data


Raw Label Data

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