Label: SHISEIDO GLOW ENHANCING PRIMER- avobenzone, octinoxate, octocrylene, and oxybenzone cream

  • NDC Code(s): 58411-239-60
  • 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

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  • 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
  • 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
    • 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•CETYL ETHYLHEXANOATE•GLYCERIN•BUTYLENE GLYCOL•CELLULOSE•DIMETHICONE•PEG-8•SD ALCOHOL 40-B•CAPRYLYL METHICONE•DIPROPYLENE GLYCOL•PEG-60 HYDROGENATED CASTOR OIL•PEG/PPG-36/41 DIMETHYL ETHER•XANTHAN GUM•GLYCYL GLYCINE•PAEONIA ALBIFLORA ROOT EXTRACT•ZINGIBER AROMATICUS EXTRACT•PPG-17•BARIUM SULFATE•TRIETHANOLAMINE•CARBOMER•ALCOHOL•ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER•SODIUM METAPHOSPHATE•DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE•BHT•ALUMINA•SODIUM METABISULFITE•TOCOPHEROL•BENZOIC ACID•FRAGRANCE•MICA•TITANIUM DIOXIDE•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 - 30 mL Tube Carton

    SHISEIDO

    Glow Enhancing
    Primer

    Smoothes on for
    a vibrant finish.
    Oil-free.

    BROAD SPECTRUM
    SPF 15
    sunscreen

    30mL NET WT. 1 OZ.

    PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    SHISEIDO GLOW ENHANCING PRIMER 
    avobenzone, octinoxate, octocrylene, and oxybenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58411-239
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE773 mg  in 30 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2287 mg  in 30 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE927 mg  in 30 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE309 mg  in 30 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETYL ETHYLHEXANOATE (UNII: 134647WMX4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-CELLULOSE (UNII: I355QGZ19A)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PEG-60 HYDROGENATED CASTOR OIL (UNII: 02NG325BQG)  
    PEG/PPG-36/41 DIMETHYL ETHER (UNII: GZ406N3R9F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    DIGLYCINE (UNII: 10525P22U0)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    PPG-17 (UNII: OV0Q322E0U)  
    BARIUM SULFATE (UNII: 25BB7EKE2E)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALCOHOL (UNII: 3K9958V90M)  
    SODIUM POLYMETAPHOSPHATE (UNII: P1BM4ZH95L)  
    DIPENTAERYTHRITYL HEXAHYDROXYSTEARATE (UNII: 74J1X57U42)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    BENZOIC ACID (UNII: 8SKN0B0MIM)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58411-239-601 in 1 CARTON02/01/2015
    130 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 finalpart35202/01/2015
    Labeler - SHISEIDO AMERICAS CORPORATION (193691821)
    Establishment
    NameAddressID/FEIBusiness Operations
    SHISEIDO AMERICA INC.782677132manufacture(58411-239) , analysis(58411-239)
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