NDC 58411-455 Cle De Peau Beaute Protective Fortifying N

Avobenzone, Octinoxate, Octocrylene, And Oxybenzone

NDC Product Code 58411-455

NDC Code: 58411-455

Proprietary Name: Cle De Peau Beaute Protective Fortifying N 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: Avobenzone, Octinoxate, Octocrylene, And Oxybenzone 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
    • 58411-455 - Cle De Peau Beaute Protective Fortifying N

NDC 58411-455-50

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

NDC Product Information

Cle De Peau Beaute Protective Fortifying N with NDC 58411-455 is a a human over the counter drug product labeled by Shiseido Americas Corporation. The generic name of Cle De Peau Beaute Protective Fortifying N is avobenzone, octinoxate, octocrylene, and oxybenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Shiseido Americas Corporation

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 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.


Cle De Peau Beaute Protective Fortifying N 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.

  • AVOBENZONE 1030 mg/50mL
  • OCTINOXATE 2524 mg/50mL
  • OCTOCRYLENE 2575 mg/50mL
  • OXYBENZONE 1030 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)
  • DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
  • TREHALOSE (UNII: B8WCK70T7I)
  • PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
  • PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
  • PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)
  • POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)
  • GINKGO (UNII: 19FUJ2C58T)
  • ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)
  • PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
  • CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
  • ASIAN GINSENG (UNII: CUQ3A77YXI)
  • GLYCINE (UNII: TE7660XO1C)
  • ONONIS SPINOSA ROOT (UNII: FD2FMC53M1)
  • ZANTHOXYLUM PIPERITUM FRUIT RIND (UNII: 728JDI7G4M)
  • SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
  • ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
  • BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
  • BEHENETH-20 (UNII: BJ4GP2IFLN)
  • PPG-17 (UNII: OV0Q322E0U)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • THEANINE (UNII: 8021PR16QO)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • ALCOHOL (UNII: 3K9958V90M)
  • SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • MICA (UNII: V8A1AW0880)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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.

Cle De Peau Beaute Protective Fortifying N Product Label Images

Cle De Peau Beaute Protective Fortifying N 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 ingredientsPurposeAVOBENZONE 2.0%SunscreenOCTINOXATE 4.9%SunscreenOCTOCRYLENE 5.0%SunscreenOXYBENZONE 2.0%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 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 10 a.m. – 2 p.m.wear long-sleeve shirts, pants, hats, and sunglasseschildren under 6 months: Ask a doctor

Inactive Ingredients

WATER • CYCLOPENTASILOXANE • GLYCERIN • DIISOPROPYL SEBACATE • BUTYLENE GLYCOL • DIETHYLHEXYL SUCCINATE • SD ALCOHOL 40-B • TREHALOSE • PEG/PPG-14/7 DIMETHYL ETHER • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER • TOCOPHERYL ACETATE • PEG/PPG-17/4 DIMETHYL ETHER • PHYTOSTERYL MACADAMIATE • POLYQUATERNIUM-51 • GINKGO BILOBA LEAF EXTRACT • ANGELICA ACUTILOBA ROOT EXTRACT • PAEONIA ALBIFLORA ROOT EXTRACT • CRATAEGUS MONOGYNA FLOWER EXTRACT • PANAX GINSENG ROOT EXTRACT • GLYCINE • ONONIS SPINOSA ROOT EXTRACT • HYDROLYZED SILK • ROSA CANINA FRUIT EXTRACT • ZANTHOXYLUM PIPERITUM PEEL EXTRACT • HIBISCUS ESCULENTUS FRUIT EXTRACT • FAGUS SYLVATICA BUD EXTRACT • SODIUM ACETYLATED HYALURONATE • PERILLA OCYMOIDES LEAF EXTRACT • ROSA ROXBURGHII FRUIT EXTRACT • HYDROLYZED CONCHIOLIN PROTEIN • ISODONIS JAPONICUS LEAF/STALK EXTRACT • BUPLEURUM FALCATUM ROOT EXTRACT • BEHENETH-20 • PPG-17 • BEHENYL ALCOHOL • CARBOMER • POLYSORBATE 20 • TRIETHANOLAMINE • DISODIUM EDTA • STEARYL ALCOHOL • HYDROXYPROPYL METHYLCELLULOSE STEAROXY ETHER • THEANINE • SODIUM CITRATE • ALCOHOL • SODIUM METAPHOSPHATE • CITRIC ACID • BHT • TOCOPHEROL • PHENOXYETHANOL • METHYLPARABEN • BENZOIC ACID • FRAGRANCE • MICA • TITANIUM DIOXIDE • IRON OXIDES •

Other Information

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

* Please review the disclaimer below.

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