Label: PERFORMANCE FACE SUNSCREEN BROAD SPECTRUM SPF 30- zinc oxide, octocrylene, octisalate cream

  • NDC Code(s): 54111-188-30, 54111-188-75
  • Packager: Bentley Laboratories, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 6, 2024

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

  • ACTIVE INGREDIENT

    DRUG FACTS

    Active Ingredients

    Zinc Oxide 9.4%

    Octocrylene 5%

    Octisalate 2%

  • PURPOSE

    Purpose

    Zinc Oxide ......... Sunscreen

    Octocrylene ....... Sunscreen

    Octisalate .......... Sunscreen

  • INDICATIONS & USAGE

    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

    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 doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of the reach of children. If swallowed get medical help

    or contact a Poison Control center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Rub evenly into your rntire face and neck. • Apply generously liberally 15 minutes before sun exposure.
    • Reapply after 40 minutes of swimming or sweating and immediately after towel drying. • Reapply at least every 2 hours

  • INACTIVE INGREDIENT

    Inactive Ingredients       Water, Butyloctyl Salicylate, Neopentyl Glycol Diheptanoate, Undecane, Glyceryl
    Stearate, Glycerin, Cetearyl Alcohol, Poly C10-30 Alkyl Acrylate, Isododecane, Tridecane, Niacinamide, Sodium Hy-
    aluronate, Phenoxyethanol, Coco-Caprylate/Caprate, Ceteareth-20, Triceteareth-4 Phosphate, Bisabolol, Caprylyl
    Glycol, Xanthan Gum, Triethoxycaprylylsilane, Citric Acid, Ethylhexylglycerin, Polyglyceryl-3 Pentaricinoleate,
    Isostearic Acid

  • Geologie Performance Face Sunscreen Broad Spectrum SPF 30

    PERSONALIZED SKINCARE

    Performance Face

    Sunscreen

    Broad Spectrum SPF30

    Geologie


    Geologie.com
    Made in USA of
    Imported Materials
    Distributed by Geologie
    New York, NY 10025

    30 mL Tube

    188-30 SPF30

    75 mL Tube

    188-75 75mL

    res

  • INGREDIENTS AND APPEARANCE
    PERFORMANCE FACE SUNSCREEN BROAD SPECTRUM  SPF 30
    zinc oxide, octocrylene, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54111-188
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION9.4 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (ETHYLHEXYL SALICYLATE - UNII:4X49Y0596W) OCTISALATE2.0 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    UNDECANE (UNII: JV0QT00NUE)  
    GLYCERYL STEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
    ISODODECANE (UNII: A8289P68Y2)  
    TRIDECANE (UNII: A3LZF0L939)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    SODIUM HYALURONATE (UNII: YSE9PPT4TH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    CETEARETH-20 (UNII: YRC528SWUY)  
    TRICETEARETH-4 PHOSPHATE (UNII: 69534Y66NO)  
    BISABOLOL (UNII: 24WE03BX2T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54111-188-3030 mL in 1 TUBE; Type 0: Not a Combination Product07/18/2023
    2NDC:54111-188-7575 mL in 1 TUBE; Type 0: Not a Combination Product07/18/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/18/2023
    Labeler - Bentley Laboratories, LLC (068351753)
    Registrant - Geologie (081158549)