Melan Spf-30 Antioxidant Body Mist Sunscreen

Melan Spf-30 Antioxidant Body Mist Sunscreen
SPL v1
SPL
SPL Set ID 66b7c899-46fd-41a6-9a96-ebbf2b68ea25
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 (75 mg) Octisalate (50 mg) Octocrylene
Inactive Ingredients
Aloe Butyloctyl Salicylate Green Tea Leaf Medium-chain Triglycerides Citrus Maxima Seed Oil Lime Oil, Cold Pressed Watermelon Orange Oil, Cold Pressed Lemon Helianthus Annuus Flowering Top Isodecyl Neopentanoate Lavender Oil Peppermint Oil Spearmint Oil Polysorbate 20 Tetrahexyldecyl Ascorbate Grape Seed Oil

Identifiers & Packaging

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

Description

Avobenzone 3.00% Homosalate 7.50% Octisalate 5.00% Octocrylene 5.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Avobenzone 3.00% Homosalate 7.50% Octisalate 5.00% Octocrylene 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

Do Not Use
  • on damaged or broken skin.
Questions?

1-888-676-3890

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.
Package Labeling:

Active Ingredients

Avobenzone 3.00%

Homosalate 7.50%

Octisalate 5.00%

Octocrylene 5.00%

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

Aloe Extract, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Cananga Odorata (Ylang Ylang) Oil, Caprylic/Capric Triglyceride, Citrus Grandis (Grapefruit) Seed Oil, Citrus Aurantifolia (Lime) Oil, Citrullus Lanatus (Watermelon) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limon (Lemon) Oil, Helianthus Annuus (Sunflower) Oil, Isodecyl Neopentanoate, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Mentha Spicata (Spearmint) Oil, Polysorbate-20, SD-Alcohol 40B, Tetrahexyldecyl Ascorbate (Vitamin C), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vitis Vinifera (Grape) Seed Oil.

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

Do Not Use (Do not use)
  • on damaged or broken skin.
Questions?

1-888-676-3890

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.
Package Labeling:

Active Ingredients

Avobenzone 3.00%

Homosalate 7.50%

Octisalate 5.00%

Octocrylene 5.00%

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

Aloe Extract, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Cananga Odorata (Ylang Ylang) Oil, Caprylic/Capric Triglyceride, Citrus Grandis (Grapefruit) Seed Oil, Citrus Aurantifolia (Lime) Oil, Citrullus Lanatus (Watermelon) Extract, Citrus Aurantium Dulcis (Orange) Oil, Citrus Medica Limon (Lemon) Oil, Helianthus Annuus (Sunflower) Oil, Isodecyl Neopentanoate, Lavandula Angustifolia (Lavender) Oil, Mentha Piperita (Peppermint) Oil, Mentha Spicata (Spearmint) Oil, Polysorbate-20, SD-Alcohol 40B, Tetrahexyldecyl Ascorbate (Vitamin C), VA/Butyl Maleate/Isobornyl Acrylate Copolymer, Vitis Vinifera (Grape) Seed Oil.

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.


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Raw Label Data

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