Melan Spf-30 Broad Spectrum Lotion

Melan Spf-30 Broad Spectrum Lotion
SPL v1
SPL
SPL Set ID 75fcef12-bc33-44a7-acda-77d5d7bca2bc
Route
TOPICAL
Published
Effective Date 2024-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Avobenzone (30 mg) Homosalate (80 mg) Octisalate (50 mg)
Inactive Ingredients
Aloe Vera Leaf Ammonium Acryloyldimethyltaurate/vp Copolymer Water Docosanol Butyloctyl Salicylate Caprylyl Glycol Cetearyl Olivate Cetyl Alcohol Watermelon Orange Oil, Cold Pressed Grapefruit Coconut Oil Diisopropyl Adipate Dodecane Ethylhexylglycerin Eucalyptus Oil Glycerin Glyceryl Laurate Helianthus Annuus Flowering Top Lauryl Lactate Peppermint Oil Basil Rice Bran Oil Panthenol Pentylene Glycol Phenoxyethanol Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Polysorbate 20 Potassium Cetyl Phosphate Rosemary Sodium Hydroxide Sorbitan Olivate Tocopherol Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-05-06

Description

Avobenzone 3.00% Homosalate 8.00% Octisalate 5.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00% Homosalate 8.00% Octisalate 5.00%

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
  • 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.
Questions?

1-888-676-3890

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

Active Ingredients

Avobenzone 3.00%

Homosalate 8.00%

Octisalate 5.00%

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua (Deionized Water), Behenyl Alcohol Butyloctyl Salicylate, Caprylyl Glycol, Cetearyl Olivate, Cetyl Alcohol, Citrullus Lanatus (Watermelon) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Grandis (Grapefruit) Oil, Cocos Nucifera (Coconut) Oil, Diisopropyl Adipate, Dodecane, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, 1-2 Hexanediol, Lauryl Lactate, Mentha Piperita (Peppermint) Oil, Ocimum Basilicum (Basil) Extract, Oryza Sativa (Rice) Bran Oil, dl-Panthenol, Pentylene Glycol, Phenoxyethanol, Polycrylene, Polysorbate-20, Potassium Cetyl Phosphate, Rosmarinus Officinalis (Rosemary) Extract, Sodium Hydroxide, Sorbitan Olivate, Tocopherol (Vitamin E), Xanthan Gum.

When Using This Product
  • keep out of eyes. Rinse with water to remove.
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
  • 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.
Questions?

1-888-676-3890

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

Active Ingredients

Avobenzone 3.00%

Homosalate 8.00%

Octisalate 5.00%

Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua (Deionized Water), Behenyl Alcohol Butyloctyl Salicylate, Caprylyl Glycol, Cetearyl Olivate, Cetyl Alcohol, Citrullus Lanatus (Watermelon) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Grandis (Grapefruit) Oil, Cocos Nucifera (Coconut) Oil, Diisopropyl Adipate, Dodecane, Ethylhexylglycerin, Eucalyptus Globulus Oil, Glycerin, Glyceryl Laurate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, 1-2 Hexanediol, Lauryl Lactate, Mentha Piperita (Peppermint) Oil, Ocimum Basilicum (Basil) Extract, Oryza Sativa (Rice) Bran Oil, dl-Panthenol, Pentylene Glycol, Phenoxyethanol, Polycrylene, Polysorbate-20, Potassium Cetyl Phosphate, Rosmarinus Officinalis (Rosemary) Extract, Sodium Hydroxide, Sorbitan Olivate, Tocopherol (Vitamin E), Xanthan Gum.

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
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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