NDC 69473-011 Alumier Md Clear Shield Broad Spectrum Spf 42 Sunscreen

Titanium Dioxide, Zinc Oxide

NDC Product Code 69473-011

NDC 69473-011-01

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

NDC 69473-011-02

Package Description: 8 mL in 1 TUBE

NDC Product Information

Alumier Md Clear Shield Broad Spectrum Spf 42 Sunscreen with NDC 69473-011 is a a human over the counter drug product labeled by Alumier Labs. The generic name of Alumier Md Clear Shield Broad Spectrum Spf 42 Sunscreen is titanium dioxide, zinc oxide. 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 Clear Shield Broad Spectrum Spf 42 Sunscreen 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 61.8 mg/mL
  • TITANIUM DIOXIDE 70 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.

  • NIACINAMIDE (UNII: 25X51I8RD4)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • ALUMINUM MONOSTEARATE (UNII: P9BC99461E)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • WATER (UNII: 059QF0KO0R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • ACACIA (UNII: 5C5403N26O)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • HYDROXYETHYL BEHENAMIDOPROPYL DIMONIUM CHLORIDE (UNII: 9CO8OUL4TH)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • GLUTATHIONE (UNII: GAN16C9B8O)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • EDETIC ACID (UNII: 9G34HU7RV0)
  • C20-40 PARETH-10 (UNII: TE3MZI4V3F)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • VITIS VINIFERA SEED (UNII: C34U15ICXA)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • RESVERATROL (UNII: Q369O8926L)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)

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.
  • 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: 07-06-2020 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: 12-31-2021 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 Clear Shield Broad Spectrum Spf 42 Sunscreen Product Label Images

Alumier Md Clear Shield Broad Spectrum Spf 42 Sunscreen 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 7%Zinc Oxide 6.18%

Purpose

Sunscreen

Use

  • Helps prevent sunburn

Warnings

  • For external use only.

When Using This Product

  • Do not use on damaged or broken skinkeep 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 exposurereapply at least every 2 hoursfor use on children less than 6 months of age, consult a health care practitionerSun 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 MDALUMIER EUROPE LTD.5 ST. FREDERICK STREETVALLETTA VLT 1470, MALTAWWW.ALUMIERMD.COMEUROPE • UNITED STATES • CANADAUNITED KINGDOMDISTRIBUTED IN CANADA BYALUMIER LABS INC.,436 LIMESTONE CRESCENTTORONTO, ON, M3J 2S4DISTRIBUTED IN THE USA BYALUMIER LABS INC.,550 COCHITUATE ROAD, SUITE 25FRAMINGHAM, MA 01701MANUFACTURED IN CANADA UNDERLICENSE FROM ALUMIER EUROPE LTD.

Product Packaging - 60 Ml

Alumier MDClear ShieldBroad Spectrum SPF 42OIL FREE SUNSCREEN LOTIONNPN 8006493060 mL/2 fl oz

* Please review the disclaimer below.