Mirabella Broad Spectrum Spf-30 Sunscreen

Mirabella Broad Spectrum Spf-30 Sunscreen
SPL v1
SPL
SPL Set ID 3ac847d5-a75d-4b32-84e1-70e4282c0d72
Route
TOPICAL
Published
Effective Date 2024-05-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (100 mg) Octisalate (50 mg) Avobenzone (30 mg)
Inactive Ingredients
Aloe Vera Leaf Water Ascorbyl Palmitate Beta Carotene Butyloctyl Salicylate Green Tea Leaf Caprylyl Glycol Cetostearyl Alcohol Cetearyl Glucoside Citric Acid Monohydrate Watermelon Carrot Dimethicone Dodecane Glycerin Glyceryl Laurate Glyceryl Monostearate Sunflower Oil Hyaluronic Acid Isododecane C13-14 Isoparaffin Laureth-7 Magnesium Aluminum Silicate Polysorbate 20 Rosemary Saccharide Isomerate Sodium Stearoyl Glutamate Stearyl Alcohol Edetate Sodium .alpha.-tocopherol Acetate Xanthan Gum

Identifiers & Packaging

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

Description

Homosalate 10.00% Octisalate 5.00% Avobenzone 3.00%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 10.00% Octisalate 5.00% Avobenzone 3.00%

Uses
  • helps prevent sunburn
  • higher SPF gives more sun 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 this risk, regulary 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?

(661) 702-9910

Other Information

protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients

Homosalate 10.00%

Octisalate 5.00%

Avobenzone 3.00%

When Using Product
  • keep out of eyes. Rinse with water to remove.
Inactive Ingredients

Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Beta-Carotene, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic Capric, Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrullus Lanatus (Watermelon Extract, Daucus Carota Sativa (Carrot) Extract, Dimethicone, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Seed Oil, Hyaluronic Acid, Isododecane, C13-14 Isoparaffin, Laureth-7, Magnesium Aluminum Silicate, Polyacrylamide, Polyhydroxystearic Acide, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extract, Saccharide Isomerate, Sodium Stearoyl Glutamate, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Xanthan Gum.

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 sun 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 this risk, regulary 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?

(661) 702-9910

Other Information (Other information)

protect the product in this container from excessive heat and direct sun.

Package Labeling:

Active Ingredients (Active ingredients)

Homosalate 10.00%

Octisalate 5.00%

Avobenzone 3.00%

When Using Product (When using product)
  • keep out of eyes. Rinse with water to remove.
Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf (Aloe Vera Gel), Aqua (Deionized Water), Ascorbyl Palmitate (Vitamin C), Beta-Carotene, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic Capric, Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Citric Acid, Citrullus Lanatus (Watermelon Extract, Daucus Carota Sativa (Carrot) Extract, Dimethicone, Dodecane, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Seed Oil, Hyaluronic Acid, Isododecane, C13-14 Isoparaffin, Laureth-7, Magnesium Aluminum Silicate, Polyacrylamide, Polyhydroxystearic Acide, Polysorbate-20, Rosmarinus Officinalis (Rosemary) Extract, Saccharide Isomerate, Sodium Stearoyl Glutamate, Stearyl Alcohol, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Trimethylsiloxysilicate, Xanthan Gum.

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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