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

Purpose

Sunscreen

Description

Avobenzone 3.00% Octisalate 5.00% Octocrylene 10.00%


Medication Information

Warnings

For external use only

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

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).

Description

Avobenzone 3.00% Octisalate 5.00% Octocrylene 10.00%

Questions?

+34 645 66 06 12 For Europe

+1 954 914 5722 For America

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

Active Ingredient

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 10.00%

Package Labeling:

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

Warnings

For external use only

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

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

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

Active Ingredient

Avobenzone 3.00%

Octisalate 5.00%

Octocrylene 10.00%

Package Labeling:

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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