NDC 82177-204 Get Mr. The Active Mineral Body Spf-30

Titanium Dioxide, Zinc Oxide

NDC Product Code 82177-204

NDC 82177-204-00

Package Description: 177 mL in 1 BOTTLE, SPRAY

NDC Product Information

Get Mr. The Active Mineral Body Spf-30 with NDC 82177-204 is a a human over the counter drug product labeled by Biomin Llc. The generic name of Get Mr. The Active Mineral Body Spf-30 is titanium dioxide, zinc oxide. The product's dosage form is liquid and is administered via topical form.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Get Mr. The Active Mineral Body Spf-30 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.


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)
  • WATERMELON (UNII: 231473QB6R)
  • DAUCUS CAROTA SUBSP. SATIVUS SEED (UNII: 9M6AAX381U)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
  • GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)
  • MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2)
  • AVOCADO OIL (UNII: 6VNO72PFC1)
  • POPULUS TREMULOIDES BARK (UNII: 5543O0CEID)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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: Biomin Llc
Labeler Code: 82177
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: 08-10-2021 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

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Get Mr. The Active Mineral Body Spf-30 Product Label Images

Get Mr. The Active Mineral Body Spf-30 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 (6.0%)Zinc Oxide (6.0%)

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.

When Using This Product,

  • Keep out of eyes. Rinse with water to remove.

Stop Use And Ask A Doctor

  • If rash or irritation occurs.

Keep Out Of Reach Of Children.

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

Directions:

  • Apply liberally 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 of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am-2pm. Wear long sleeve shirts, pants, hats and sunglasses. For children under 6 months: consult a physician.

Inactive Ingredients:

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric  Triglyceride, Caprylyl/Capryl Glucoside, Citrullus Lanatus (Watermelon) Extract, Daucus Carota Sativa (Carrot) Seed Extract, Gluconolactone, Glycerin, Glyceryl Caprylate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower) Oil, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Lonicera japonica (Honeysuckle) Flower Extract, Mangifera Indica (Mango) Seed Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Populus Tremuloides Bark Extract, Stearic Acid, Tocopherol (Vitamin E), Xanthan Gum.

Other Information:

Protect this product from excessive heat and direct sun.

Questions?:

+1 866 438 6712

* Please review the disclaimer below.