Label: SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N- avobenzone, octinoxate, octocrylene, and oxybenzone cream

  • NDC Code(s): 58411-295-60
  • 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 December 13, 2018

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    AVOBENZONE 2.5% Sunscreen
    OCTINOXATE 7.4% Sunscreen
    OCTOCRYLENE 3.0% 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

    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.

  • Directions

    • 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•SD ALCOHOL 40-B•DIMETHICONE•DIPROPYLENE GLYCOL•DIISOPROPYL SEBACATE•GLYCERIN•PEG-60 HYDROGENATED CASTOR OIL•POTASSIUM METHOXYSALICYLATE•XANTHAN GUM•PEG/PPG-14/7 DIMETHYL ETHER•TOCOPHERYL ACETATE•2-O-ETHYL ASCORBIC ACID•ASCORBYL TETRAISOPALMITATE•SODIUM HYALURONATE•PAEONIA SUFFRUTICOSA ROOT EXTRACT•CRATAEGUS MONOGYNA FLOWER EXTRACT•POLYQUATERNIUM-51•REHMANNIA CHINENSIS ROOT EXTRACT•UNCARIA GAMBIR EXTRACT•HOUTTUYNIA CORDATA EXTRACT•PPG-17•PEG-240/HDI COPOLYMER BIS-DECYLTETRADECETH-20 ETHER•TRIETHANOLAMINE•SILICA•ISOSTEARIC ACID•BUTYLENE GLYCOL•CARBOMER•ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER•ALCOHOL•BHT•SODIUM METAPHOSPHATE•DISODIUM EDTA•TOCOPHEROL•ZINC OXIDE•SODIUM METABISULFITE•ALUMINA•PRUNUS YEDOENSIS LEAF EXTRACT•METHYLPARABEN•ETHYLPARABEN•PHENOXYETHANOL•FRAGRANCE•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 - 50 mL Tube Carton

    SHI SEIDO

    WHITE LUCENT

    All Day Brightener

    BROAD SPECTRUM
    SPF 23

    SUNSCREEN

    PROAPPROACH×2

    50mL NET WT. 1.8 OZ.

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO WHITE LUCENT ALL DAY BRIGHTENER N 
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-295
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1283 mg  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3796 mg  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1539 mg  in 50 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE513 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PAEONIA SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    PPG-17 (UNII: OV0Q322E0U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-295-601 in 1 CARTON02/01/2017
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2017
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132manufacture(58411-295) , analysis(58411-295)