Active Ingredients
Titanium Dioxide 7%
Zinc Oxide 6.18%
Alumier Md Clear Shield Broad Spectrum Spf 42 Sunscreen Lotion
FDA Label NDC 69473-011
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Alumier Labs for the product Alumier Md Clear Shield Broad Spectrum Spf 42 Sunscreen (NDC 69473-011). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients, purpose, use, warnings, when using this product, stop use and ask a doctor, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Use
- helps prevent sunburn
Warnings
- For external use only.
When Using This Product
- do not use on damaged or broken skin
- keep out of eyes. Rinse with water to remove.
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 Centre or get medical help right away.
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
Inactive Ingredients
Water/Aqua/Eau, C12-15 Alkyl Benzoate, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Niacinamide, Propanediol, Butyloctyl Salicylate, Cetearyl Alcohol, Aluminium Stearate, Glycerin, 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, Synthetic Wax, C20-40 Pareth-10, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Polyquatemium-67, Xanthan Gum, Disodium EDTA, Alumina, Ethylhexylglycerin, Phenoxyethanol.
Company Information
Alumier MD
ALUMIER EUROPE LTD.
5 ST. FREDERICK STREET
VALLETTA VLT 1470, MALTA
WWW.ALUMIERMD.COM
EUROPE • UNITED STATES • CANADA
UNITED KINGDOM
DISTRIBUTED IN CANADA BY
ALUMIER LABS INC.,
436 LIMESTONE CRESCENT
TORONTO, ON, M3J 2S4
DISTRIBUTED IN THE USA BY
ALUMIER LABS INC.,
550 COCHITUATE ROAD, SUITE 25
FRAMINGHAM, MA 01701
MANUFACTURED IN CANADA UNDER
LICENSE FROM ALUMIER EUROPE LTD.
Product Packaging - 60 Ml
Alumier MD
Clear Shield
Broad Spectrum SPF 42
OIL FREE SUNSCREEN LOTION
NPN 80064930
60 mL/2 fl oz
* Please review the disclaimer below.
