NDC 73626-050 Biomi Action De Gala Mineral Sunscreen Spf30

Titanium Dioxide, Zinc Oxide

NDC Product Code 73626-050

NDC 73626-050-01

Package Description: 1 TUBE in 1 BOX > 50 mL in 1 TUBE (73626-050-00)

NDC Product Information

Biomi Action De Gala Mineral Sunscreen Spf30 with NDC 73626-050 is a a human over the counter drug product labeled by Dectronique (1984) Inc. The generic name of Biomi Action De Gala Mineral Sunscreen Spf30 is titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Dectronique (1984) Inc

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Biomi Action De Gala Mineral Sunscreen Spf30 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.

  • TITANIUM DIOXIDE 2 g/100mL
  • ZINC OXIDE 18.4 g/100mL

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.

  • CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE (UNII: U73D397055)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • C10-18 TRIGLYCERIDES (UNII: 43AGM4PHPI)
  • SODIUM CITRATE (UNII: 1Q73Q2JULR)
  • PANAX GINSENG ROOT OIL (UNII: P9T4K47OM0)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
  • SALICYLIC ACID (UNII: O414PZ4LPZ)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • SORBIC ACID (UNII: X045WJ989B)
  • CETYL ALCOHOL (UNII: 936JST6JCN)

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: Dectronique (1984) Inc
Labeler Code: 73626
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 03-01-2020 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.

Biomi Action De Gala Mineral Sunscreen Spf30 Product Label Images

Biomi Action De Gala Mineral Sunscreen Spf30 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 2.0%

Zinc Oxide 18.4%

Purpose

Sunscreen

Uses

▪ Helps prevent sunburn. ▪ If used as directed with other sun protection measures (see
Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only

Do Not Use

On damaged or broken skin.

Stop Use And Ask A Doctor If

Rash occurs.

Keep Out Of Reach Of Children

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

Directions

▪ Apply liberally and evenly 15 minutes before sun exposure ▪ Reapply ▪ After 80 minutes of swimming or sweating ▪ Immediately after towel drying ▪ 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

Protect the product in this container from excessive heat and direct sun.

Inactive Ingredients

C10-18 Triglycerides, Sodium Citrate, Panax Ginseng Extract*, Tocopherol, Propanediol, Potassium Sorbate, Sodium Stearoyl Glutamate, Hyaluronate Sodium, Aloe Barbadensis Leaf Juice*, Coco-Caprylate, Alumina, Glycerin, Stearic Acid, Xanthan Gum, Lecithin, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Salicylic Acid, Benzyl Alcohol, Isostearic Acid, Sorbic Acid, Cetyl Alcohol, Caprylic/Capric/ Linoleic Triglyceride, Glyceryl Stearate.*Certified Organic.

* Please review the disclaimer below.