NDC 58411-457 Shiseido Waso Color-smart Day Moisturizer Oil-free

Octinoxate And Titanium Dioxide

NDC Product Code 58411-457

NDC Code: 58411-457

Proprietary Name: Shiseido Waso Color-smart Day Moisturizer Oil-free Additional informationCallout TooltipWhat 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: Octinoxate And Titanium Dioxide Additional informationCallout TooltipWhat 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.


Code Structure
  • 58411 - Shiseido Americas Corporation
    • 58411-457 - Shiseido Waso Color-smart Day Moisturizer Oil-free

NDC 58411-457-60

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE

NDC Product Information

Shiseido Waso Color-smart Day Moisturizer Oil-free with NDC 58411-457 is a a human over the counter drug product labeled by Shiseido Americas Corporation. The generic name of Shiseido Waso Color-smart Day Moisturizer Oil-free is octinoxate and titanium dioxide. The product's dosage form is emulsion and is administered via topical form.

Labeler Name: Shiseido Americas Corporation

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 Additional informationCallout TooltipWhat 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 Waso Color-smart Day Moisturizer Oil-free Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTINOXATE 4177 mg/50mL
  • TITANIUM DIOXIDE 2992 mg/50mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: 657L0NC5MT)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • TALC (UNII: 7SEV7J4R1U)
  • ERYTHRITOL (UNII: RA96B954X6)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TREHALOSE (UNII: B8WCK70T7I)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)
  • CAFFEINE (UNII: 3G6A5W338E)
  • BETAINE (UNII: 3SCV180C9W)
  • PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
  • PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
  • DIGLYCINE (UNII: 10525P22U0)
  • PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
  • LAMIUM ALBUM FLOWERING TOP (UNII: T95771X2XI)
  • CITRUS JUNOS SEED (UNII: UY43O1Q45N)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • EDETATE TRISODIUM (UNII: 420IP921MB)
  • ALCOHOL (UNII: 3K9958V90M)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • MICA (UNII: V8A1AW0880)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-01-2019 Additional informationCallout TooltipWhat 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: 12-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Shiseido Waso Color-smart Day Moisturizer Oil-free Product Label Images

Shiseido Waso Color-smart Day Moisturizer Oil-free 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

Flammable. Do not use near heat, flame, or while smoking.

Otc - Purpose

Active ingredientsPurposeOCTINOXATE 7.4%SunscreenTITANIUM DIOXIDE 5.3%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 exposureuse a water resistant sunscreen if swimming or sweatingreapply at 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

WATER∙CYCLOPENTASILOXANE∙SD ALCOHOL 40-B GLYCERIN∙METHYL METHACRYLATE CROSSPOLYMER∙DIMETHICONE∙PEG-10 DIMETHICONE∙POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER∙LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE∙POLYMETHYLSILSESQUIOXANE∙TALC∙ERYTHRITOL∙SILICA∙TREHALOSE∙DISTEARDIMONIUM HECTORITE∙TRIMETHYLSILOXYSILICATE∙CAFFEINE∙BETAINE∙PEG/PPG-17/4 DIMETHYL ETHER∙PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE∙DIPEPTIDE-15∙ERIOBOTRYA JAPONICA LEAF PROTOPLASTS∙PAEONIA ALBIFLORA ROOT EXTRACT∙LAMIUM ALBUM FLOWER/LEAF/STEM EXTRACT∙CITRUS JUNOS SEED EXTRACT∙ERIOBOTRYA JAPONICA LEAF EXTRACT∙ALUMINUM HYDROXIDE∙STEARIC ACID ISOSTEARIC ACID∙BUTYLENE GLYCOL∙TRISODIUM EDTA∙POLYESTER-1 ALCOHOL∙SILICA DIMETHYL SILYLATE∙ALUMINA∙TRIETHOXYCAPRYLYLSILANE HYDROGEN DIMETHICONE∙BHT∙TOCOPHEROL∙PHENOXYETHANOL∙BENZOIC ACID∙FRAGRANCE TITANIUM DIOXIDE IRON OXIDES MICA∙

Other Information

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

* Please review the disclaimer below.

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