Alumier Md Post Procedure Kit

Alumier Md Post Procedure Kit
SPL v1
SPL
SPL Set ID 252859de-6676-5e07-e063-6394a90a64a1
Route
TOPICAL
Published
Effective Date 2019-06-27
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
Xylitol Caprylic Acid Ethylhexylglycerin Hyaluronate Sodium Lecithin, Sunflower Polyhydroxystearic Acid (2300 Mw) Butylene Glycol Tricaprylin Niacinamide Caprylyl Methicone Polygonum Aviculare Top Triethoxycaprylylsilane Water Glyceryl Monostearate Acacia Polyoxyl 20 Cetostearyl Ether Ascorbic Acid Butyloctyl Salicylate Glycerin Vitis Vinifera Seed Aluminum Monostearate Medium-chain Triglycerides Xanthan Gum Alkyl (c12-15) Benzoate Propanediol Carboxymethylcellulose Sodium, Unspecified Form .alpha.-tocopherol Acetate Microcrystalline Cellulose Edetic Acid Cetostearyl Alcohol Peg-100 Stearate Aluminum Oxide Glutathione Phenoxyethanol Resveratrol Tocopherol Physalis Angulata Poly(methyl Methacrylate; 450000 Mw) Sodium Benzoate Dimethicone Caprylyl Glycol Pentylene Glycol Potassium Sorbate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-23

Description

Titanium Dioxide 7% Zinc Oxide 6.18%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Titanium Dioxide 7% Zinc Oxide 6.18%

Use
  • helps prevent sunburn
Directions
  • apply liberally/generously (and evenly) 15 minutes before sun exposure
  • reapply 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, 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 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
Product Packaging

Active 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 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, Xylitol, Caprylic Acid, Caprylyl Glycol, Polymethyl Methacrylate, Tricaprylin, Sodium Benzoate, Potassium Sorbate, Pentylene Glycol, Ethylhexylglycerin.

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

Directions
  • apply liberally/generously (and evenly) 15 minutes before sun exposure
  • reapply 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, 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 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
Product Packaging

Active 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 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, Xylitol, Caprylic Acid, Caprylyl Glycol, Polymethyl Methacrylate, Tricaprylin, Sodium Benzoate, Potassium Sorbate, Pentylene Glycol, Ethylhexylglycerin.

Stop Use and Ask A Doctor (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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