Alumier Md Sheer Hydration

Alumier Md Sheer Hydration
SPL v5
SPL
SPL Set ID 88dedeb8-963f-5849-e053-2995a90aab72
Route
TOPICAL
Published
Effective Date 2019-05-14
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
Medium-chain Triglycerides Aluminum Monostearate Triethoxycaprylylsilane Water Cetostearyl Alcohol Glyceryl Monostearate Peg-100 Stearate Acacia Polyoxyl 20 Cetostearyl Ether Aluminum Oxide Xanthan Gum Hydroxyethyl Behenamidopropyl Dimonium Chloride Alkyl (c12-15) Benzoate Propanediol Glutathione Ascorbic Acid Microcrystalline Cellulose Edetic Acid Carboxymethylcellulose Sodium, Unspecified Form C20-40 Pareth-10 Ethylhexylglycerin Phenoxyethanol Butyloctyl Salicylate Glycerin Vitis Vinifera Seed Resveratrol .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-01 Until 2023-02-28

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
Section 50565-1

Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.

Section 50566-9

Stop use and ask a doctor if you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing

Section 50567-7

When using this product

  • do not use on damaged or broken skin
  • keep out of eyes. Rinse with water to remove.

Warnings
  • For external use only.
Directions
  • apply liberally/generously (and evenly) 15 minutes before sun exposure
  • reapply at least every 2 hours
  • for use on children less than 6 months of age, consult a health care practitioner
  • 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

Other Information
  • 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., 550 Cochituate Road, Suite 25, Framingham, MA 01701

Active Ingredients

Titanium Dioxide 7%

Zinc Oxide 6.28%

Inactive Ingredients

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Butyloctyl Salicylate, Cetearyl Alcohol, Aluminium Stearate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Lecithin (Syn. Phosphatidycholine), Vitis Vinifera Seed Extract, Resveratrol, Glutathione, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Acacia Senegal Gum, Synthetic Wax, Polyhydroxysteric Acid, Ceteareth-20, Alumina, Microcrystalline Cellulose, Triethoxycaprylylsilane, Xanthan Gum, Cellulose Gum, C20-4O Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquatemium-67, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol.

Product Packaging 236 Ml

Alumier MD

Sheer Hydration

Broad Spectrum SPF 40

MOISTURIZING SUNSCREEN LOTION

UNTINTED

NPN 80064932

236 mL / 8 fl oz


Structured Label Content

Use
  • helps prevent sunburn
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, call a Poison Control Centre or get medical help right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if you develop severe irritation, burning or itching of the skin, hives, swelling of eyes and mouth, blistering or difficulty breathing

Section 50567-7 (50567-7)

When using this product

  • do not use on damaged or broken skin
  • keep out of eyes. Rinse with water to remove.

Purpose

Sunscreen

Warnings
  • For external use only.
Directions
  • apply liberally/generously (and evenly) 15 minutes before sun exposure
  • reapply at least every 2 hours
  • for use on children less than 6 months of age, consult a health care practitioner
  • 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

Other Information
  • 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., 550 Cochituate Road, Suite 25, Framingham, MA 01701

Active Ingredients

Titanium Dioxide 7%

Zinc Oxide 6.28%

Inactive Ingredients

Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Propanediol, Butyloctyl Salicylate, Cetearyl Alcohol, Aluminium Stearate, Glycerin, Glyceryl Stearate, PEG-100 Stearate, Lecithin (Syn. Phosphatidycholine), Vitis Vinifera Seed Extract, Resveratrol, Glutathione, Tocopheryl Acetate, Magnesium Ascorbyl Phosphate, Acacia Senegal Gum, Synthetic Wax, Polyhydroxysteric Acid, Ceteareth-20, Alumina, Microcrystalline Cellulose, Triethoxycaprylylsilane, Xanthan Gum, Cellulose Gum, C20-4O Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquatemium-67, Disodium EDTA, Ethylhexylglycerin, Phenoxyethanol.

Product Packaging 236 Ml (Product Packaging - 236 mL)

Alumier MD

Sheer Hydration

Broad Spectrum SPF 40

MOISTURIZING SUNSCREEN LOTION

UNTINTED

NPN 80064932

236 mL / 8 fl oz


Advanced Ingredient Data


Raw Label Data

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