Label: SHISEIDO ESSENTIAL ENERGY HYDRATING DAY- homosalate, octocrylene, octisalate, and avobenzone emulsion

  • NDC Code(s): 58411-656-60
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 23, 2024

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    AVOBENZONE 2.0%Sunscreen
    HOMOSALATE 5.0%Sunscreen
    OCTISALATE 5.0%Sunscreen
    OCTOCRYLENE 5.0%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.

    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 two 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 ∙ GLYCERIN ∙ DIPROPYLENE GLYCOL ∙ ISODECYL NEOPENTANOATE ∙ PEG-20 ∙ AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER ∙ ERYTHRITOL ∙ PEG/PPG-14/7 DIMETHYL ETHER ∙ PEG/PPG-17/4 DIMETHYL ETHER ∙ LAURYL BETAINE ∙ XANTHAN GUM ∙ 2-O-ETHYL ASCORBIC ACID ∙ CAFFEINE ∙ PHYTOSTERYL MACADAMIATE ∙ SODIUM HYALURONATE ∙ CITRUS UNSHIU PEEL EXTRACT ∙ ANGELICA KEISKEI LEAF/STEM EXTRACT ∙ ZIZIPHUS JUJUBA FRUIT EXTRACT ∙ PANAX GINSENG ROOT EXTRACT ∙ SODIUM ACETYLATED HYALURONATE ∙ SCUTELLARIA BAICALENSIS ROOT EXTRACT ∙ SANGUISORBA OFFICINALIS ROOT EXTRACT ∙ PYROLA INCARNATA EXTRACT ∙ BEHENYL ALCOHOL ∙ SILICA ∙ DIGLYCERIN ∙ POLYSILICONE-11 ∙ BATYL ALCOHOL ∙ BUTYLENE GLYCOL ∙ BIS-BUTYLDIMETHICONE POLYGLYCERYL-3 ∙ CARBOMER ∙ POTASSIUM HYDROXIDE ∙ PEG-60 GLYCERYL ISOSTEARATE ∙ ALCOHOL ∙ TOCOPHEROL ∙ BHT ∙ ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER ∙ SODIUM METABISULFITE ∙ ISOSTEARIC ACID ∙ DISODIUM EDTA ∙ SODIUM METAPHOSPHATE ∙ PPG-3 DIPIVALATE ∙ SYZYGIUM JAMBOS LEAF EXTRACT ∙ ALPINIA SPECIOSA LEAF EXTRACT ∙ ROSMARINUS OFFICINALIS (ROSEMARY) LEAF EXTRACT ∙ PHENOXYETHANOL ∙ SODIUM BENZOATE ∙ FRAGRANCE ∙ 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

    ESSENTIAL ENERGY

    Hydrating Day Cream
    BROAD SPECTRUM SPF 20
    SUNSCREEN
    ANTI-POLLUTION

    Hyaluronic Acid RED

    50mL NET WT. 1.7 OZ.

    PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO ESSENTIAL ENERGY HYDRATING DAY 
    homosalate, octocrylene, octisalate, and avobenzone emulsion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-656
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE2.53 g  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.53 g  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.53 g  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.012 g  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DIGLYCERIN (UNII: 3YC120743U)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H)  
    BATILOL (UNII: 39YR661C4U)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    PEG/PPG-17/4 DIMETHYL ETHER (UNII: 4ET18WJG5K)  
    ERYTHRITOL (UNII: RA96B954X6)  
    PEG-60 GLYCERYL ISOSTEARATE (UNII: WQP0973914)  
    LAURYL BETAINE (UNII: Y4P927Q133)  
    ALCOHOL (UNII: 3K9958V90M)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    CAFFEINE (UNII: 3G6A5W338E)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    PHYTOSTERYL MACADAMIATE (UNII: 233VSF903M)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TANGERINE PEEL (UNII: JU3D414057)  
    ANGELICA KEISKEI TOP (UNII: AP628M4TQO)  
    JUJUBE FRUIT (UNII: G55HNL2C70)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
    ALPINIA ZERUMBET LEAF (UNII: MS8P33AMKX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    ROSEMARY (UNII: IJ67X351P9)  
    SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-656-601 in 1 CARTON05/01/2021
    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 DRUGM02005/01/2021
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)