NDC 70157-004 City Sunscreen Serum Broad Spectrum Spf 30 Supergoop

Homosalate, Octisalate, Avobenzene, Octocrylene

NDC Product Code 70157-004

NDC CODE: 70157-004

Proprietary Name: City Sunscreen Serum Broad Spectrum Spf 30 Supergoop What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Homosalate, Octisalate, Avobenzene, Octocrylene What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 70157 - Baxter Laboratories Pty. Ltd.
    • 70157-004 - City Sunscreen Serum Broad Spectrum Spf 30

NDC 70157-004-11

Package Description: 480 kg in 1 DRUM

NDC Product Information

City Sunscreen Serum Broad Spectrum Spf 30 Supergoop with NDC 70157-004 is a a human over the counter drug product labeled by Baxter Laboratories Pty. Ltd.. The generic name of City Sunscreen Serum Broad Spectrum Spf 30 Supergoop is homosalate, octisalate, avobenzene, octocrylene. The product's dosage form is cream and is administered via topical form.

Labeler Name: Baxter Laboratories Pty. Ltd.

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.

City Sunscreen Serum Broad Spectrum Spf 30 Supergoop 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.

  • HOMOSALATE 8 g/100kg
  • OCTISALATE 4 g/100kg
  • AVOBENZONE 3 g/100kg
  • OCTOCRYLENE 2 g/100kg

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.

  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • SERINE (UNII: 452VLY9402)
  • UREA (UNII: 8W8T17847W)
  • SORBITOL (UNII: 506T60A25R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ALLANTOIN (UNII: 344S277G0Z)
  • OLEYL ALCOHOL (UNII: 172F2WN8DV)
  • ETHYL LINOLEATE (UNII: MJ2YTT4J8M)

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: Baxter Laboratories Pty. Ltd.
Labeler Code: 70157
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: 12-07-2010 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 - 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".

* Please review the disclaimer below.

City Sunscreen Serum Broad Spectrum Spf 30 Supergoop Product Label Images

City Sunscreen Serum Broad Spectrum Spf 30 Supergoop 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: PurposeHomosalate 8%, Octisalate 4%, Avobenzene 3%, Octocrylene 2% Sunscreen

Otc - Purpose

PurposeUses Simultaneously protects skin, combats premature aging and moisturizes on contacthelps prevent sunburnIf used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging skin aging caused by the sun

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

Warnings

WarningsFor external use only.Do not use on damaged or broken skinWhen using this product, keep out of of eyes.Rinse with water to remove.If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions: Apply liberally 15 minutes before sun exposureUse a water resistant sunscreen if swimming or sweatingReapply at least every 2 hourschildren under 6 months: ask a doctorSun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreenwith Broad Spectrum SPF value of 15 or higher and other sun protection measures including:Limit time in the sun,especially from 10 a.m. -2p.m.Wear long-sleeved shirts, pants, hats, and sunglasses

Inactive Ingredient

Inactive Ingredients Purified water (Aqua), Cyclometicone, Isostearyl Neopentanoate, Glycerin, Ceteareth-20, Polypropylene, Cetearyl Alcohol, Xanthan Gum, d-Panthenol, Octanohydroxamic acid, Caprylyl Glycol, Silica, Triacontanyl PVP, Cetyl Dimethicone, Ammonium Acryloyldimethyltaurate/VP Copolymer, PEG-40 Stearate, Tocopheryl, Disodium EDTA, Pentylene Glycol, Pantheyl Triacetate, Sodium Lactate, Lactic Acid, Serine, Urea, Sorbitol, Sodium Chloride, Allantoin, Oleyl Alcohol, Ethyl Linoleate.

* Please review the disclaimer below.