NDC 69473-014 Alumier Md Moisture Matte Broad Spectrum Spf 40 Sunscreen Amber

Zinc Oxide, Titanium Dioxide

NDC Product Code 69473-014

NDC 69473-014-01

Package Description: 1 TUBE in 1 CARTON > 60 mL in 1 TUBE

NDC 69473-014-02

Package Description: 8 mL in 1 TUBE

NDC Product Information

Alumier Md Moisture Matte Broad Spectrum Spf 40 Sunscreen Amber with NDC 69473-014 is a a human over the counter drug product labeled by Alumier Labs. The generic name of Alumier Md Moisture Matte Broad Spectrum Spf 40 Sunscreen Amber is zinc oxide, titanium dioxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Alumier Labs

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Alumier Md Moisture Matte Broad Spectrum Spf 40 Sunscreen Amber Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ZINC OXIDE 90 mg/mL
  • TITANIUM DIOXIDE 83 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • WATER (UNII: 059QF0KO0R)
  • SQUALANE (UNII: GW89575KF9)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • SILIBININ (UNII: 4RKY41TBTF)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAFFEINE (UNII: 3G6A5W338E)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Alumier Labs
Labeler Code: 69473
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 02-04-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Alumier Md Moisture Matte Broad Spectrum Spf 40 Sunscreen Amber Product Label Images

Alumier Md Moisture Matte Broad Spectrum Spf 40 Sunscreen Amber Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Active Ingredients

Titanium Dioxide 8.3%Zinc Oxide 9%

Purpose

Sunscreen

Use

  • Helps prevent sunburn.

Warnings

For external use only.

Do Not Use

On damaged or broken skin.

When Using This Product

Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

If rash occurs.

Keep Out Of Reach Of Children.

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

Directions

  • Apply liberally 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.Store in a cool, dry place at room temperature (15-30C).Protect the product in this container from excessive heat and direct sun.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

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.

Company Information

Distributed in the USA by Alumier Labs Inc.,550 Cochituate Road, Suite 25Framingham, MA 01701

* Please review the disclaimer below.