Label: SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL LIGHT- octinoxate and titanium dioxide cream
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM NATURAL- octinoxate and titanium dioxide cream
SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM MEDIUM- octinoxate and titanium dioxide cream

  • NDC Code(s): 58411-296-10, 58411-297-10, 58411-298-10
  • Packager: SHISEIDO AMERICAS CORPORATION
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 23, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose
    OCTINOXATE 2.9%Sunscreen
    TITANIUM DIOXIDE 2.6%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.

  • 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•DIMETHICONE•GLYCERIN•SD ALCOHOL 40-B•METHYL METHACRYLATE CROSSPOLYMER•DIISOSTEARYL MALATE•BETAINE•PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE•PEG-10 DIMETHICONE•SORBITAN SESQUIISOSTEARATE•POTASSIUM METHOXYSALICYLATE•TRIMETHYLSILOXYSILICATE•DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER•TOCOPHERYL ACETATE•2-O-ETHYL ASCORBIC ACID•SODIUM HYALURONATE•PAEONIA SUFFRUTICOSA ROOT EXTRACT•PEG/PPG-14/7 DIMETHYL ETHER•REHMANNIA CHINENSIS ROOT EXTRACT•UNCARIA GAMBIR EXTRACT•CHLORELLA VULGARIS EXTRACT•ALUMINUM HYDROXIDE•DISTEARDIMONIUM HECTORITE•ALUMINUM DISTEARATE•POLYSILICONE-2•DISODIUM EDTA•SILICA•BUTYLENE GLYCOL•ALANINE•SODIUM CITRATE•ALCOHOL•BHT・TOCOPHEROL•CITRIC ACID•BARIUM SULFATE•SODIUM METABISULFITE•PRUNUS YEDOENSIS LEAF EXTRACT•HYDROGEN DIMETHICONE•ALUMINA•METHYLPARABEN•ETHYLPARABEN・FRAGRANCE•TITANIUM DIOXIDE•IRON OXIDES•MICA•

  • 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 - 4 mL Bottle Carton - Natural Light

    SHISEIDO

    WHITE LUCENT

    OnMakeup
    Spot Correcting
    Serum

    BROAD SPECTRUM
    SPF 25

    SUNSCREEN

    PROAPPROACH×2

    4mL NET WT. .16 OZ.

    PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Natural Light
  • PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Natural

    SHISEIDO

    WHITE LUCENT

    OnMakeup
    Spot Correcting
    Serum

    BROAD SPECTRUM
    SPF 25

    SUNSCREEN

    PROAPPROACH×2

    4mL NET WT. .16 OZ.

    PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Natural
  • PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Medium

    SHISEIDO

    WHITE LUCENT

    OnMakeup
    Spot Correcting
    Serum

    BROAD SPECTRUM
    SPF 25

    SUNSCREEN

    PROAPPROACH×2

    4mL NET WT. .16 OZ.

    PRINCIPAL DISPLAY PANEL - 4 mL Bottle Carton - Medium
  • INGREDIENTS AND APPEARANCE
    SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM   NATURAL LIGHT
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-296
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE138 mg  in 4 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE123 mg  in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    BETAINE (UNII: 3SCV180C9W)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALANINE (UNII: OF5P57N2ZX)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-296-101 in 1 CARTON02/01/2017
    14 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02002/01/2017
    SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM   NATURAL
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-297
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE138 mg  in 4 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE123 mg  in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    BETAINE (UNII: 3SCV180C9W)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALANINE (UNII: OF5P57N2ZX)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-297-101 in 1 CARTON02/01/2017
    14 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02002/01/2017
    SHISEIDO WHITE LUCENT ONMAKEUP SPOT CORRECTING SERUM   MEDIUM
    octinoxate and titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-298
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE138 mg  in 4 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE123 mg  in 4 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    BETAINE (UNII: 3SCV180C9W)  
    PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POTASSIUM METHOXYSALICYLATE (UNII: 5G3H7U4Y7F)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    2-O-ETHYL ASCORBIC ACID (UNII: 801M14RK9K)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PAEONIA X SUFFRUTICOSA ROOT (UNII: 7M7E9A2C8J)  
    PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)  
    REHMANNIA GLUTINOSA ROOT (UNII: 1BEM3U6LQQ)  
    CHLORELLA VULGARIS (UNII: RYQ4R60M02)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALANINE (UNII: OF5P57N2ZX)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    PRUNUS X YEDOENSIS LEAF (UNII: 1Z125GA907)  
    HYDROGEN DIMETHICONE (13 CST) (UNII: 4QGR4P2YOI)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-298-101 in 1 CARTON02/01/201705/01/2022
    14 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02002/01/201705/01/2022
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132manufacture(58411-296, 58411-297, 58411-298) , analysis(58411-296, 58411-297, 58411-298)