NDC 58411-672 Shiseido Urban Environment Oil-free Mineral Sunscreen Spf 42

Titanium Dioxide And Zinc Oxide

NDC Product Code 58411-672

NDC CODE: 58411-672

Proprietary Name: Shiseido Urban Environment Oil-free Mineral Sunscreen Spf 42 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: Titanium Dioxide And Zinc Oxide 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

  • 58411 - Shiseido Americas Corporation
    • 58411-672 - Shiseido Urban Environment Oil-free Mineral Sunscreen Spf 42

NDC 58411-672-10

Package Description: 1 BOTTLE in 1 CARTON > 30 mL in 1 BOTTLE

NDC Product Information

Shiseido Urban Environment Oil-free Mineral Sunscreen Spf 42 with NDC 58411-672 is a a human over the counter drug product labeled by Shiseido Americas Corporation. The generic name of Shiseido Urban Environment Oil-free Mineral Sunscreen Spf 42 is titanium dioxide and zinc oxide. The product's dosage form is emulsion and is administered via topical form.

Dosage Form: Emulsion - A dosage form consisting of a two-phase system comprised of at least two immiscible liquids1, one of which is dispersed as droplets (internal or dispersed phase) within the other liquid (external or continuous phase), generally stabilized with one or more emulsifying agents. (Note: Emulsion is used as a dosage form term unless a more specific term is applicable, e.g. cream, lotion, ointment.)

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.

Shiseido Urban Environment Oil-free Mineral Sunscreen Spf 42 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.

  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • WATER (UNII: 059QF0KO0R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
  • ISODODECANE (UNII: A8289P68Y2)
  • HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)
  • PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
  • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • TREHALOSE (UNII: B8WCK70T7I)
  • PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
  • ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)
  • THIOTAURINE (UNII: NQZ2D7AO62)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
  • PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
  • GARCINIA MANGOSTANA BARK (UNII: N6A4WY566I)
  • TURMERIC (UNII: 856YO1Z64F)
  • PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • EDETATE TRISODIUM (UNII: 420IP921MB)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • ALCOHOL (UNII: 3K9958V90M)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • SODIUM METABISULFITE (UNII: 4VON5FNS3C)
  • BARIUM SULFATE (UNII: 25BB7EKE2E)
  • SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

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: Shiseido Americas Corporation
Labeler Code: 58411
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: 01-01-2022 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".

* Please review the disclaimer below.

Shiseido Urban Environment Oil-free Mineral Sunscreen Spf 42 Product Label Images

Shiseido Urban Environment Oil-free Mineral Sunscreen Spf 42 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

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposeTITANIUM DIOXIDE 4.9%SunscreenZINC OXIDE 13.6% Sunscreen

Uses

  • Helps prevent sunburnif 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

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs.

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.

Directions

  • For sunscreen use:apply liberally 15 minutes before sun exposurereapply:after 40 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun 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 10 a.m. – 2 p.m.wear long-sleeve shirts, pants, hats, and sunglasseschildren under 6 months: Ask a doctor

Inactive Ingredients

DIMETHICONE • WATER • SILICA • ZINC OXIDE • DIPROPYLENE GLYCOL • GLYCERIN • CAPRYLYL METHICONE • DIPHENYLSILOXY PHENYL TRIMETHICONE • ISODODECANE • HYDROGENATED POLYDECENE • PEG/PPG-14/7 DIMETHYL ETHER • PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE • BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 • PEG-10 DIMETHICONE • TREHALOSE • PHYTOSTERYL MACADAMIATE • ASCORBYL TETRAISOPALMITATE • THIOTAURINE • DIPOTASSIUM GLYCYRRHIZATE • SCUTELLARIA BAICALENSIS ROOT EXTRACT • PAEONIA ALBIFLORA ROOT EXTRACT • SODIUM HYALURONATE • SANGUISORBA OFFICINALIS ROOT EXTRACT • CAMELLIA SINENSIS LEAF EXTRACT • ONONIS SPINOSA ROOT EXTRACT • GARCINIA MANGOSTANA BARK EXTRACT • CURCUMA LONGA (TURMERIC) RHIZOME EXTRACT • PERILLA OCYMOIDES LEAF EXTRACT • SPIRULINA PLATENSIS EXTRACT • ALUMINUM HYDROXIDE • HYDROGEN DIMETHICONE • TRIETHOXYCAPRYLYLSILANE • BUTYLENE GLYCOL • ISOSTEARIC ACID • DISTEARDIMONIUM HECTORITE • TRISODIUM EDTA • SODIUM CITRATE • ALCOHOL • CITRIC ACID • SODIUM METABISULFITE • POLYSILICONE-2 • BARIUM SULFATE • SYZYGIUM JAMBOS LEAF EXTRACT • TOCOPHEROL • PHENOXYETHANOL • BENZOIC ACID • IRON OXIDES •

Other Information

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

* Please review the disclaimer below.