Alumier Md Moisture Matte Broad Spectrum Spf 40 Sunscreen

Alumier Md Moisture Matte Broad Spectrum Spf 40 Sunscreen
SPL v5
SPL
SPL Set ID ba864a08-e66d-d286-e053-2995a90a1854
Route
TOPICAL
Published
Effective Date 2021-02-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (90 mg) Titanium Dioxide (83 mg)
Inactive Ingredients
Water Squalane Disteardimonium Hectorite .alpha.-tocopherol Acetate Hexyl Laurate Polyglyceryl-4 Isostearate Polygonum Aviculare Top Peg-10 Dimethicone (600 Cst) Argan Oil Ferric Oxide Yellow Ferrosoferric Oxide Cyclomethicone 5 Glycerin Butylene Glycol Polymethylsilsesquioxane (4.5 Microns) Lecithin, Soybean Phenylethyl Alcohol Stearic Acid Silica Dimethyl Silylate Sodium Chloride Hyaluronate Sodium Silibinin Levomenol Phenoxyethanol Caffeine Cetyl Peg/ppg-10/1 Dimethicone (hlb 2) Aluminum Oxide Mica Ferric Oxide Red Ethylhexylglycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-02-04 Until 2022-03-31

Description

Amber Shade: Titanium Dioxide 8.3% Zinc Oxide 9% Ivory and Sand Shades: Titanium Dioxide 7.8% Zinc Oxide 9%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Amber Shade: Titanium Dioxide 8.3% Zinc Oxide 9% Ivory and Sand Shades: Titanium Dioxide 7.8% Zinc Oxide 9%

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.
  • 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

Amber Shade:

Titanium Dioxide 8.3%

Zinc Oxide 9%

Ivory and Sand Shades:

Titanium Dioxide 7.8%

Zinc Oxide 9%

Company Information

Distributed in the USA by Alumier Labs Inc.,

550 Cochituate Road, Suite 25

Framingham, MA 01701

Inactive Ingredients

Cyclopentasiloxane, Water/Aqua/Eau, Squalane, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Argania Spinosa Kernel Oil, Butylene Glycol, Disteardimonium Hectorite, Tocopheryl Acetate, Hexyl Laurate, Polymethylsilsesquioxane, Polyglyceryl-4 Isostearate, Caffeine, Sodium Chloride, Polygonum Aviculare Extract, Sodium Hyaluronate, Lecithin (Syn. Phosphatidylcholine), Silybin, Bisabolol, Phenethyl Alcohol, Stearic Acid, Alumina, Mica, Polyester-1, Silica Dimethyl Silylate, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Ethylhexylglycerin, Phenoxyethanol.

When Using This Product
  • do not use on damaged or broken skin
  • keep out of eyes. Rinse with water to remove.
Product Packaging Sand

Product Packaging Amber

Product Packaging Ivory

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.

Keep Out of Reach of Children.

If swallowed, call a Poison Control Center 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.
  • 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 (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 (Active ingredients)

Amber Shade:

Titanium Dioxide 8.3%

Zinc Oxide 9%

Ivory and Sand Shades:

Titanium Dioxide 7.8%

Zinc Oxide 9%

Company Information

Distributed in the USA by Alumier Labs Inc.,

550 Cochituate Road, Suite 25

Framingham, MA 01701

Inactive Ingredients (Inactive ingredients)

Cyclopentasiloxane, Water/Aqua/Eau, Squalane, PEG-10 Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Glycerin, Argania Spinosa Kernel Oil, Butylene Glycol, Disteardimonium Hectorite, Tocopheryl Acetate, Hexyl Laurate, Polymethylsilsesquioxane, Polyglyceryl-4 Isostearate, Caffeine, Sodium Chloride, Polygonum Aviculare Extract, Sodium Hyaluronate, Lecithin (Syn. Phosphatidylcholine), Silybin, Bisabolol, Phenethyl Alcohol, Stearic Acid, Alumina, Mica, Polyester-1, Silica Dimethyl Silylate, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Ethylhexylglycerin, Phenoxyethanol.

When Using This Product (When using this product)
  • do not use on damaged or broken skin
  • keep out of eyes. Rinse with water to remove.
Product Packaging Sand (Product Packaging - Sand)

Product Packaging Amber (Product Packaging - Amber)

Product Packaging Ivory (Product Packaging - Ivory)

Stop Use and Ask A Doctor (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.

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

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


Advanced Ingredient Data


Raw Label Data

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