NDC 58411-259 Cle De Peau Beaute Protective Fortifying

Product Information

Product Code58411-259
Proprietary Name 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.
Cle De Peau Beaute Protective Fortifying
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Shiseido Americas Corporation
Labeler Code58411
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
02-01-2016
Listing Expiration Date 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.
12-31-2019
Exclude Flag 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".
I
NDC Code Structure

Usage Information


Product Packages

NDC 58411-259-10

Package Description: 1 BOTTLE in 1 CARTON > 125 mL in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

Cle De Peau Beaute Protective Fortifying is product labeled by Shiseido Americas Corporation. The product's dosage form is and is administered via form.


What are Cle De Peau Beaute Protective Fortifying Active Ingredients?

The following is the list of active ingredients in this product. An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

  • AVOBENZONE (UNII: G63QQF2NOX)
  • AVOBENZONE (UNII: G63QQF2NOX) (Active Moiety)
  • OCTINOXATE (UNII: 4Y5P7MUD51)
  • OCTINOXATE (UNII: 4Y5P7MUD51) (Active Moiety)
  • OCTOCRYLENE (UNII: 5A68WGF6WM)
  • OCTOCRYLENE (UNII: 5A68WGF6WM) (Active Moiety)
  • OXYBENZONE (UNII: 95OOS7VE0Y)
  • OXYBENZONE (UNII: 95OOS7VE0Y) (Active Moiety)


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)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)
  • XYLITOL (UNII: VCQ006KQ1E)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ISODODECANE (UNII: A8289P68Y2)
  • PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
  • PEG-5 GLYCERYL STEARATE (UNII: 8CAC4NQ872)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ISOSTEARIC ACID (UNII: X33R8U0062)
  • TREHALOSE (UNII: B8WCK70T7I)
  • DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)
  • SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
  • GINKGO (UNII: 19FUJ2C58T)
  • PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
  • CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)
  • CAFFEINE (UNII: 3G6A5W338E)
  • SERINE (UNII: 452VLY9402)
  • 2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)
  • BUPLEURUM FALCATUM ROOT (UNII: X04E310LUY)
  • ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)
  • PPG-17 (UNII: OV0Q322E0U)
  • TROLAMINE (UNII: 9O3K93S3TK)
  • GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • BEHENIC ACID (UNII: H390488X0A)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • BATILOL (UNII: 39YR661C4U)
  • THEANINE (UNII: 8021PR16QO)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
  • SODIUM METAPHOSPHATE (UNII: 532IUT7IRV)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • ALCOHOL (UNII: 3K9958V90M)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • ETHYLPARABEN (UNII: 14255EXE39)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • BENZOIC ACID (UNII: 8SKN0B0MIM)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)


* Please review the disclaimer below.

Cle De Peau Beaute Protective Fortifying Labeling and Warnings

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Other



Drug Facts


Otc - Purpose



Active ingredientsPurpose
AVOBENZONE 2.5%Sunscreen
OCTINOXATE 7.4%Sunscreen
OCTOCRYLENE 2.0%Sunscreen
OXYBENZONE 1.0%Sunscreen

Uses



  • 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

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 exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply 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 sunglasses
    • children under 6 months: Ask a doctor

Inactive Ingredients



WATER (AQUA/EAU) • DIPROPYLENE GLYCOL • SD ALCOHOL 40-B • GLYCERIN • HYDROGENATED POLYDECENE • XYLITOL • DIMETHICONE • ISODODECANE • PEG/PPG-14/7 DIMETHYL ETHER • PEG-5 GLYCERYL STEARATE • SILICA • ISOSTEARIC ACID • TREHALOSE • DIPHENYLSILOXY PHENYL TRIMETHICONE • XANTHAN GUM • TOCOPHERYL ACETATE • PEG/PPG-17/4 DIMETHYL ETHER • PHYTOSTERYL MACADAMIATE • POLYQUATERNIUM-51 • SODIUM ACETYLATED HYALURONATE • GINKGO BILOBA LEAF EXTRACT • PAEONIA ALBIFLORA ROOT EXTRACT • CRATAEGUS MONOGYNA FLOWER EXTRACT • CAFFEINE • SERINE • HYDROLYZED SILK • 2-O-ETHYL ASCORBIC ACID • BUPLEURUM FALCATUM ROOT EXTRACT • UNCARIA GAMBIR EXTRACT • ROSA ROXBURGHII FRUIT EXTRACT • HYDROLYZED CONCHIOLIN PROTEIN • PPG-17 • TRIETHANOLAMINE • GLYCERYL STEARATE SE • BEHENYL ALCOHOL • BEHENIC ACID • STEARIC ACID • BATYL ALCOHOL • PEG-30 SOY STEROL • THEANINE • BUTYLENE GLYCOL • CARBOMER • DISODIUM EDTA • CELLULOSE GUM • SODIUM METAPHOSPHATE • BHT • ALCOHOL • TOCOPHEROL • METHYLPARABEN • ETHYLPARABEN • PHENOXYETHANOL • BENZOIC ACID • FRAGRANCE (PARFUM) • TITANIUM DIOXIDE • MICA • IRON OXIDES •


Other Information



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

Questions Or Comments?



Call toll free 1-800-906-7503


Principal Display Panel - 125 Ml Bottle Carton



clé de peau
BEAUTÉ

protective fortifying emulsion
BROAD SPECTRUM SPF 22
SUNSCREEN

DIN 02440814

125mL 4.2 FL. OZ.


* Please review the disclaimer below.