Alumier Md Sheer Hydration Tinted Moisturizing Sunscreen

Alumier Md Sheer Hydration Tinted Moisturizing Sunscreen
SPL v3
SPL
SPL Set ID a951ebe7-7786-38ef-e053-2995a90a70e3
Route
TOPICAL
Published
Effective Date 2020-06-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (62.8 mg) Titanium Dioxide (70 mg)
Inactive Ingredients
Caprylic Acid Sodium Polyacrylate (2500000 Mw) Hydrogenated Olive Oil Unsaponifiables Potassium Sorbate Butylene Glycol Physalis Angulata Caprylyl Glycol Pentylene Glycol Xylitol Ferric Oxide Red Ferric Oxide Yellow Lecithin, Soybean Medium-chain Triglycerides Aluminum Monostearate Triethoxycaprylylsilane Water Cetostearyl Alcohol Glyceryl Monostearate Peg-100 Stearate Acacia Polyoxyl 20 Cetostearyl Ether Aluminum Oxide Xanthan Gum 1,2-hexanediol Alkyl (c12-15) Benzoate Propanediol Glutathione Ascorbic Acid Microcrystalline Cellulose Edetic Acid Carboxymethylcellulose Sodium, Unspecified Form Tricaprylin Ethylhexylglycerin Sodium Benzoate Butyloctyl Salicylate Glycerin Vitis Vinifera Seed Resveratrol .alpha.-tocopherol Acetate Polyhydroxystearic Acid (2300 Mw) Ferrosoferric Oxide Squalane Polygonum Aviculare Whole Poly(methyl Methacrylate; 450000 Mw) Tocopherol Hyaluronate Sodium Pongamia Pinnata Seed Extract

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-06-30 Until 2024-12-03

Description

Titanium Dioxide 7% Zinc Oxide 6.28%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 7% Zinc Oxide 6.28%

Use
  • helps prevent sunburn
Warnings
  • For external use only.
Directions
  • apply liberally/generously (and evenly) 15 minutes before sun exposure
  • reapply at least every 2 hours
  • adults 18 years and older
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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
  • use a water resistant sunscreen if swimming or sweating

Do Not Use
  • on broken or damaged skin
Other Information
  • Store in a cool, dry place at room temperature.
  • Do not use if security seal on box is broken or missing.
  • You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 945 Concord Street, Framingham, MA 01701

Active Ingredients

Titanium Dioxide 7%

Zinc Oxide 6.28%

When Using This Product
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Non Medicinal Ingredients

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Glycerin, Butyloctyl Salicylate, Squalane, Cetearyl Alcohol, Aluminium Stearate, Glyceryl Stearate, Peg-100 Stearate, Lecithin, Vitis Vinifera (Grape) Seed Extract, Resveratrol, Glutathione, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Acacia Senegal Gum, Sodium Hyaluronate, Polyhydroxystearic Acid, Ceteareth-20, Alumina, Microcrystalline Cellulose, Triethoxycaprylylsilane, Physalis Angulata Extract, Pongamia Pinnata Seed Extract, Polygonum Aviculare Extract, Hydrogenated Olive Oil Unsaponifiables, Alteromonas Ferment Extract, Pentylene Glycol, 1,2-hexanediol, Polymethyl Methacrylate, Caprylyl Glycol, Xylitol, Caprylic Acid, Butylene Glycol, Cellulose Gum, Xanthan Gum, Tricaprylin, Sodium Benzoate, Potassium Sorbate, Disodium EDTA, Sodium Polyacrylate, Tocopherol, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Ethylhexylglycerin.

Product Packaging 60 Ml

Stop Use and Ask A Doctor If
  • rash occurs

Keep Out of Reach of Children.

If swallowed, call a Poison Control Centre or get medical help right away.


Structured Label Content

Use
  • helps prevent sunburn
Purpose

Sunscreen

Warnings
  • For external use only.
Directions
  • apply liberally/generously (and evenly) 15 minutes before sun exposure
  • reapply at least every 2 hours
  • adults 18 years and older
  • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value 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
  • use a water resistant sunscreen if swimming or sweating

Do Not Use (Do not use)
  • on broken or damaged skin
Other Information
  • Store in a cool, dry place at room temperature.
  • Do not use if security seal on box is broken or missing.
  • You may report a serious adverse reaction event from using this product to: Alumier Labs Inc., 945 Concord Street, Framingham, MA 01701

Active Ingredients

Titanium Dioxide 7%

Zinc Oxide 6.28%

When Using This Product (When using this product)
  • avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Non Medicinal Ingredients (Non-medicinal ingredients)

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Glycerin, Butyloctyl Salicylate, Squalane, Cetearyl Alcohol, Aluminium Stearate, Glyceryl Stearate, Peg-100 Stearate, Lecithin, Vitis Vinifera (Grape) Seed Extract, Resveratrol, Glutathione, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Acacia Senegal Gum, Sodium Hyaluronate, Polyhydroxystearic Acid, Ceteareth-20, Alumina, Microcrystalline Cellulose, Triethoxycaprylylsilane, Physalis Angulata Extract, Pongamia Pinnata Seed Extract, Polygonum Aviculare Extract, Hydrogenated Olive Oil Unsaponifiables, Alteromonas Ferment Extract, Pentylene Glycol, 1,2-hexanediol, Polymethyl Methacrylate, Caprylyl Glycol, Xylitol, Caprylic Acid, Butylene Glycol, Cellulose Gum, Xanthan Gum, Tricaprylin, Sodium Benzoate, Potassium Sorbate, Disodium EDTA, Sodium Polyacrylate, Tocopherol, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Ethylhexylglycerin.

Product Packaging 60 Ml (Product Packaging - 60 mL)

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, call a Poison Control Centre or get medical help right away.


Advanced Ingredient Data


Raw Label Data

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