NDC 10028-020 Starter Set Oily/normal Skin

Zinc Oxide

NDC Product Code 10028-020

NDC 10028-020-01

Package Description: 1 KIT in 1 PACKAGE, COMBINATION * 100 mL in 1 BOTTLE (10028-021-01) * 75 mL in 1 BOTTLE * 200 mL in 1 BOTTLE * 30 mL in 1 BOTTLE

NDC Product Information

Starter Set Oily/normal Skin with NDC 10028-020 is a a human over the counter drug product labeled by Ultraceuticals Pty Limited. The generic name of Starter Set Oily/normal Skin is zinc oxide. The product's dosage form is kit and is administered via topical form.

Labeler Name: Ultraceuticals Pty Limited

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ALLANTOIN (UNII: 344S277G0Z)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ISODODECANE (UNII: A8289P68Y2)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • CARNOSINE (UNII: 8HO6PVN24W)
  • METHYLPROPANEDIOL (UNII: N8F53B3R4R)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • CAFFEINE (UNII: 3G6A5W338E)
  • POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • PHENYLPROPANOL (UNII: 0F897O3O4M)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)
  • TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
  • WATER (UNII: 059QF0KO0R)
  • POLYETHYLENE GLYCOL 500 (UNII: 761NX2Q08Y)

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: Ultraceuticals Pty Limited
Labeler Code: 10028
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.

Starter Set Oily/normal Skin Product Label Images

Starter Set Oily/normal Skin 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

Otc - Active Ingredient

Active Ingredients PurposeZinc Oxide 12% w/w Sunscreen

Otc - Purpose

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.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.If product is swallowed, get medical help or contact a poison Control Center right away

Indications & Usage

  • Stop use and ask a doctor ifrash occurs or irritation develops and lasts.

Warnings

  • WarningsDo not use:on damaged or broken skinWhen using this productkeep out of eyes. Rinse with water to removeFor external use only

Dosage & Administration

  • DirectionsApply liberally 15 minutes before sun exposure and at least every 2 hoursChildren under 6 monthsSun 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 your time in the sun, especially from 10 a.m. – 2 p.m.Wear long-sleeved shirts, pants, hats, and sunglassesof age: ask a doctor.reapply after 40 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hours

Inactive Ingredient

Inactive IngredientsAllantoin, Bisabolol Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Caffeine, Caprylyl Glycol, Caprylyl Methicone, Carnosine, Dimethicone, Isododecane, Lauryl PEG-10 Tris(Trimethylsiloxy) Silylethyl Dimethicone, Lauryl PEG-8 Dimethicone, Methylpropanediol, Niacinamide, Octyldodecyl Neopentanoate, PEG-10, Phenylpropanol, Polymethylsilsesquioxane, Propanediol, Silica, Sodium Chloride, Sodium Hydroxide, Tetrasodium Glutamate Diacetate, Triceteareth-4 Phosphate, Tridecyl Salicylate, Water.

* Please review the disclaimer below.