Label: AEKYUNGLUNA LONG LASTING TIP CONCEALER FIXING-FIT 01 LIGHT BEIGE- titanium dioxide cream

  • NDC Code(s): 67225-2024-1, 67225-2024-2
  • Packager: Aekyung Industrial Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

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 April 12, 2021

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  • Active ingredient

    Titanium dioxide 22.68 %

  • Uses

    Helps prevent sunburn

  • Warnings

    For external use only.

  • Do not use

    on damaged skin 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 swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    ■ Apply an appropriate amount to the area that
    needs to be covered, then tap it with your fingers to absorb
    cleanly. ■ Apply liberally 15 minutes before sun exposure. 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 value of 15
    or higher and other sunprotection measuring including:
    • limit time in the sun, especially from 10 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    ■ Children under 6 months of age: Ask a doctor
    ■ Reapply at least every 2 hours.
    ■ Use a water-resistant sunscreen if swimming or sweating.

  • Other information

    ■ Store at room temperature

  • Inactive ingredients

    Water, Cyclopentasiloxane, Phenyl
    Trimethicone, Silica, Cetyl PEG/PPG-10/1 Dimethicone,
    Butylene Glycol, Talc, Trimethylsiloxysilicate, Niacinamide, Vinyl
    Dimethicone/Methicone Silsesquioxane Crosspolymer, Sodium Chloride,
    PEG-10 Dimethicone, Polymethylsilsesquioxane, Triethoxycaprylylsilane,
    Disteardimonium Hectorite, Aluminum Hydroxide, Acrylates/Stearyl
    Acrylate/Dimethicone Methacrylate Copolymer, p-Anisic Acid, Glyceryl
    Caprylate, Palmitic Acid, Dimethicone, Stearic Acid, Adenosine,
    1,2-Hexanediol, Rosmarinus Officinalis (Rosemary) Leaf Extract,
    Thymus Vulgaris (Thyme) Leaf Extract, Chamaecyparis Obtusa Leaf
    Extract, Pinus Sylvestris Cone Extract, Pinus Koraiensis Seed Extract,
    Fragrance, May contain: Iron Oxides (CI 77492, CI 77491, CI 77499)

  • PRINCIPAL DISPLAY PANEL

    01 Light Beige

  • INGREDIENTS AND APPEARANCE
    AEKYUNGLUNA LONG LASTING TIP CONCEALER FIXING-FIT 01 LIGHT BEIGE 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67225-2024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.7 g  in 7.5 g
    Inactive Ingredients
    Ingredient NameStrength
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    PINUS KORAIENSIS SEED OIL (UNII: 08F703RHY3)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ADENOSINE (UNII: K72T3FS567)  
    PINUS SYLVESTRIS CONE (UNII: 856B44M480)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TALC (UNII: 7SEV7J4R1U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    THYMUS VULGARIS LEAF (UNII: GRX3499643)  
    TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
    DIMETHICONE 100 (UNII: RO266O364U)  
    ROSEMARY (UNII: IJ67X351P9)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67225-2024-21 in 1 BOX04/13/2021
    1NDC:67225-2024-17.5 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/13/2021
    Labeler - Aekyung Industrial Co., Ltd. (690511126)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aekyung Industrial Co., Ltd.690511126manufacture(67225-2024)