Active Ingredients
Titanium Dioxide 7%
Zinc Oxide 6.18%
Alumier Md Post Procedure Kit
FDA Label NDC 69473-019
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 Post Procedure Kit (NDC 69473-019). 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, do not use, 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
Do Not Use
- on broken skin
When Using This Product
- avoid contact with eyes. If contact occurs, rinse thoroughly with water.
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.
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
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
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.
Product Packaging
1 (Sensicalm1)
1 (Clearshield1)
1 (Rescuebalm1)
1 (Carton)
1 (Inside)
1 (Insert)
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