Label: CLE DE PEAU BEAUTE BRIGHTENING ENHANCER VEIL- octinoxate, octocrylene, and titanium dioxide emulsion

  • NDC Code(s): 58411-838-10
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated May 12, 2022

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    Octinoxate 7.4%Sunscreen
    Octocrylene 2.5%Sunscreen
    Titanium Dioxide 6.6%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

    Do not use on damaged or broken skin

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

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

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

  • 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 value 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•DIMETHICONE•TRISILOXANE•BUTYLENE GLYCOL•GLYCERIN•ISOPROPYL MYRISTATE•SD ALCOHOL 40-B•PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•SILICA•BARIUM SULFATE•POTASSIUM METHOXYSALICYLATE•TREHALOSE•HYDROGENATED POLYISOBUTENE•SODIUM POLYACRYLATE•TOCOPHERYL ACETATE•GLYCINE•CAMELLIA SINENSIS LEAF EXTRACT•PEG/PPG-14/7 DIMETHYL ETHER•ROSA ROXBURGHII FRUIT EXTRACT•ANGELICA ACUTILOBA ROOT EXTRACT•HYDROLYZED CONCHIOLIN PROTEIN•HYDROLYZED SILK•PERILLA OCYMOIDES LEAF EXTRACT•PPG-17•ALUMINUM HYDROXIDE•DISTEARDIMONIUM HECTORITE•HYDROGEN DIMETHICONE•STEARIC ACID•TRISODIUM EDTA•BUTYROSPERMUM PARKII (SHEA) BUTTER•CITRIC ACID•SODIUM CITRATE•ALCOHOL•TALC•BHT•TOCOPHEROL•SODIUM METABISULFITE•POLYSILICONE-2•THEANINE•BIS-BUTYLDIMETHICONE POLYGLYCERYL-3•PHENOXYETHANOL•FRAGRANCE•TITANIUM DIOXIDE•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 - 30 mL Bottle Box

    clé de peau
    BEAUTÉ

    BRIGHTENING
    ENHANCER VEIL

    BROAD SPECTRUM
    SPF 32
    SUNSCREEN

    30mL 1 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Bottle Box
  • INGREDIENTS AND APPEARANCE
    CLE DE PEAU BEAUTE BRIGHTENING ENHANCER VEIL 
    octinoxate, octocrylene, and titanium dioxide emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-838
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2220 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE750 mg  in 30 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1980 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TREHALOSE (UNII: B8WCK70T7I)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCINE (UNII: TE7660XO1C)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    ROSA ROXBURGHII FRUIT (UNII: CVT1AA87FF)  
    ANGELICA ACUTILOBA ROOT (UNII: 3W51R3EK30)  
    PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)  
    PPG-17 (UNII: OV0Q322E0U)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ALCOHOL (UNII: 3K9958V90M)  
    TALC (UNII: 7SEV7J4R1U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    THEANINE (UNII: 8021PR16QO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-838-101 in 1 BOX04/01/2022
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/01/2022
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
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