Label: SHISEIDO WHITE LUCENT DAY- avobenzone, octinoxate, and octocrylene emulsion

  • NDC Code(s): 58411-463-10
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 15, 2019

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
  • 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

    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
    • children under 6 months: ask a doctor
    • 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
  • Inactive Ingredients

    Water, SD Alcohol 40-B, Dimethicone, Dipropylene Glycol, Glycerin, Diisopropyl Sbeacate, Peg-60 Hydrogenated Castor Oil, Potassium Methoxysalicylate, Erythritol, Xanthan Gum, Tocopheryl Acetate, Peg/PPG-14/7 Dimethyl Ether, Peg/PPG-17/4 Dimethyl Ether, Dipotassium Glycyrrhizate, 2-O-Ethyl Ascorbic Acid, Caffeine, Ascorbyl Tetraisopalmitate, Phytosteryl Macadamiate, Angelica Keiskei Leaf/Stem Extract, Paeonia Albiflora Root Extract, Cratagus Monogyna Flower Extract, Rehmannia Chinesis Root Extract, Ziziphu Jujuba Fruit Extract, Polyquaternium 51, PPG-17, Peg-240/HDI Copolymer BIS-Decyltetradeceth-20 Ether, Triethanolamine, Silica, Butylene Glycol, Isostearic Acid, PPG-3 Dipivalate, HDI/Trimethylol Hexyllactone Crosspolymer, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, BHT, Sodium Metaphosphate, Alcohol, Tocopherol, Disodium EDTA, Sodium Metabisulfite, Prunus Yedoensis Leaf Extract, Phenoxyethanol, Benzoic Acid, 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

    SHISEIDO
    GINZA TOKYO

    White Lucent

    Day Emulsion

    BROAD SPECTRUM
    SPF 23

    SUNSCREEN

    ReNeura Technology+™

    50mL NET WT. 1.7 OZ.

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO WHITE LUCENT DAY 
    avobenzone, octinoxate, and octocrylene emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-463
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.285 g  in 50 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE3.8036 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.542 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIISOPROPYL SEBACATE (UNII: J8T3X564IH)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    ERYTHRITOL (UNII: RA96B954X6)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ASCORBYL TETRAISOPALMITATE (UNII: 47143LT58A)  
    PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
    ANGELICA KEISKEI TOP (UNII: AP628M4TQO)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    CRATAEGUS MONOGYNA FLOWER (UNII: NT52AMP29J)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    JUJUBE FRUIT (UNII: G55HNL2C70)  
    POTENTILLA ERECTA ROOT (UNII: BI896CKT6B)  
    POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) (UNII: EL9825H96J)  
    PPG-17 (UNII: OV0Q322E0U)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-463-101 in 1 CARTON01/01/2019
    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 FINALpart35201/01/2019
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICAS INC.782677132MANUFACTURE(58411-463) , ANALYSIS(58411-463)