Alumier Md Clear Shield Sunscreen

Alumier Md Clear Shield Sunscreen
SPL v5
SPL
SPL Set ID a9c970c8-b6e3-b0a1-e053-2a95a90a89c7
Route
TOPICAL
Published
Effective Date 2025-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (61.8 mg) Titanium Dioxide (70 mg)
Inactive Ingredients
Physalis Angulata Sodium Benzoate Potassium Sorbate Medium-chain Triglycerides Niacinamide Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Aluminum Monostearate Triethoxycaprylylsilane Water Cetostearyl Alcohol Glyceryl Monostearate Peg-100 Stearate Acacia Aluminum Oxide Xanthan Gum Ceteareth-20 Alkyl (c12-15) Benzoate Propanediol Glutathione Ascorbic Acid Microcrystalline Cellulose Butylene Glycol Lecithin, Soybean Edetic Acid Xylityl Sesquicaprylate Butyloctyl Salicylate Glycerin Vitis Vinifera Seed Polyhydroxystearic Acid (2300 Mw) Resveratrol .alpha.-tocopherol Acetate Dimethicone Hyaluronate Sodium Carboxymethylcellulose Sodium, Unspecified Form Pentylene Glycol Tocopherol Anhydroxylitol Caprylyl Glycol Tricaprylin Ethylhexylglycerin Caprylyl Methicone Polygonum Aviculare Top Poly(methyl Methacrylate; 450000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-07-06 Until 2026-01-01

Description

Product Facts enclosed

Purpose

Sun Protectant


Medication Information

Purpose

Sun Protectant

Description

Product Facts enclosed

Uses
  • 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
Product Facts

Product Facts enclosed

Other Information
  • Store in a cool, dry place at room temperature.
  • Protect the product in this container from excessive heat and direct sun.
  • Do not use if security seal 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, USA

Medicinal Ingredients

Titanium Dioxide 7%

Zinc Oxide 6.18%

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, Niacinamide, Propanediol, Dimethicone, Butyloctyl Salicylate, Glycerin, Caprylyl Methicone, Cetearyl Alcohol, Aluminium Stearate, Glyceryl Stearate, Peg-100 Stearate, Vitis Vinifera (Grape) Seed Extract, Sodium Hyaluronate, Resveratrol, Lecithin, Magnesium Ascorbyl Phosphate, Tocopheryl Acetate, Glutathione, Acacia Senegal Gum, Cellulose Gum, Microcrystalline Cellulose, Polysilicone-11, Triethoxycaprylylsilane, Ceteareth-20, Polyhydroxystearic Acid, Xanthan Gum, Disodium EDTA, Alumina, Tocopherol, Alteromonas Ferment Extract, Butylene Glycol, Physalis Angulata Extract, Polygonum Aviculare Extract, Xylityl Sesquicaprylate, Anhydroxyxlitol, Caprylyl Glycol, Polymethyl Methacrylate, Tricaprylin, Sodium Benzoate, Potassium Sorbate, Pentylene Glycol, Ethylhexylglycerin.

Product Packaging 236 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

Uses
  • helps prevent sunburn
Purpose

Sun Protectant

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
Product Facts

Product Facts enclosed

Other Information
  • Store in a cool, dry place at room temperature.
  • Protect the product in this container from excessive heat and direct sun.
  • Do not use if security seal 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, USA

Medicinal Ingredients

Titanium Dioxide 7%

Zinc Oxide 6.18%

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, Niacinamide, Propanediol, Dimethicone, Butyloctyl Salicylate, Glycerin, Caprylyl Methicone, Cetearyl Alcohol, Aluminium Stearate, Glyceryl Stearate, Peg-100 Stearate, Vitis Vinifera (Grape) Seed Extract, Sodium Hyaluronate, Resveratrol, Lecithin, Magnesium Ascorbyl Phosphate, Tocopheryl Acetate, Glutathione, Acacia Senegal Gum, Cellulose Gum, Microcrystalline Cellulose, Polysilicone-11, Triethoxycaprylylsilane, Ceteareth-20, Polyhydroxystearic Acid, Xanthan Gum, Disodium EDTA, Alumina, Tocopherol, Alteromonas Ferment Extract, Butylene Glycol, Physalis Angulata Extract, Polygonum Aviculare Extract, Xylityl Sesquicaprylate, Anhydroxyxlitol, Caprylyl Glycol, Polymethyl Methacrylate, Tricaprylin, Sodium Benzoate, Potassium Sorbate, Pentylene Glycol, Ethylhexylglycerin.

Product Packaging 236 Ml (Product Packaging - 236 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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