Label: SHISEIDO EXTRA SMOOTH SUN PROTECTION N- octinoxate, octocrylene, and zinc oxide lotion

  • NDC Code(s): 58411-349-10
  • 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 December 27, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:Purpose
    OCTINOXATE 4.9%Sunscreen
    OCTOCRYLENE 3.0%Sunscreen
    ZINC OXIDE 12.5%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
    • reapply:
      • after 80 minutes of swimming or sweating
      • immediately after towel drying
      • 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

    DIMETHICONE, WATER, DIPROPYLENE GLYCOL, ETHYLHEXYL PALMITATE, SD ALCOHOL 40-B, PEG-10 DIMETHICONE, TALC, POLYBUTYLENE GLYCOL/PPG-9/1 COPOLYMER, TRIMETHYLSILOXYSILICATE, XYLITOL, GLYCERIN, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, METHYL GLUCETH-10, SCUTELLARIA BAICALENSIS ROOT EXTRACT, ECTOIN, ISOSTEARIC ACID, HYDROGEN DIMETHICONE, DISTEARDIMONIUM HECTORITE, BUTYLENE GLYCOL, CALCIUM STEARATE, TRISODIUM EDTA, ALUMINA, BHT, TRIETHOXYCAPRYLYLSILANE, SYZYGIUM JAMBOS LEAF EXTRACT, TOCOPHEROL, PHENOXYETHANOL, FRAGRANCE, TITANIUM DIOXIDE,

  • Other information

    • protect this product in this container from excessive heat and direct sun.
  • Questions or comments?

    Call toll free 1-800-906-7503

  • SPL UNCLASSIFIED SECTION

    SHISEIDO AMERICA INC.
    NEW YORK, N.Y. 10022

    SHISEIDO DIST.
    NEW YORK • PARIS • MILANO

  • PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton

    SHISEIDO
    GINZA TOKYO

    Extra Smooth
    Sun Protection Lotion N

    38

    BROAD SPECTRUM
    SPF 38

    For Face/Body

    WATER RESISTANT
    (80 MINUTES)

    SUNSCREEN

    100mL 3.3 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 100 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO EXTRA SMOOTH SUN PROTECTION N 
    octinoxate, octocrylene, and zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-349
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5424 mg  in 110.7 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE3321 mg  in 110.7 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13.84 g  in 110.7 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    WATER (UNII: 059QF0KO0R)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    TALC (UNII: 7SEV7J4R1U)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    XYLITOL (UNII: VCQ006KQ1E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYL GLUCETH-10 (UNII: N0MWT4C7WH)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    ECTOINE (UNII: 7GXZ3858RY)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CALCIUM STEARATE (UNII: 776XM7047L)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-349-101 in 1 CARTON02/01/2013
    1110.7 g in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35202/01/2013
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132MANUFACTURE(58411-349) , ANALYSIS(58411-349)
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