[De-listing] 67225-2024-2 AEKYUNGLUNA LONG LASTING Tip Concealer FIXING-FIT 01 Light Beige

AEKYUNGLUNA LONG LASTING Tip Concealer FIXING-FIT 01 Light Beige by

Drug Labeling and Warnings

AEKYUNGLUNA LONG LASTING Tip Concealer FIXING-FIT 01 Light Beige by is a Otc medication manufactured, distributed, or labeled by Aekyung Industrial Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AEKYUNGLUNA LONG LASTING TIP CONCEALER FIXING-FIT 01 LIGHT BEIGE- titanium dioxide cream 
Aekyung Industrial Co., Ltd.

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.

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[De-listing] 67225-2024-2
AEKYUNGLUNA LONG LASTING Tip Concealer FIXING-FIT 01 Light Beige

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)

01 Light Beige

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)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
WATER (UNII: 059QF0KO0R)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ADENOSINE (UNII: K72T3FS567)  
PINUS SYLVESTRIS CONE (UNII: 856B44M480)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
PALMITIC ACID (UNII: 2V16EO95H1)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CHAMAECYPARIS OBTUSA LEAF (UNII: 7OL154J5XB)  
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
TALC (UNII: 7SEV7J4R1U)  
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
ROSEMARY (UNII: IJ67X351P9)  
NIACINAMIDE (UNII: 25X51I8RD4)  
THYMUS VULGARIS LEAF (UNII: GRX3499643)  
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN)  
DIMETHICONE 100 (UNII: RO266O364U)  
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 finalpart35204/13/202105/11/2022
Labeler - Aekyung Industrial Co., Ltd. (690511126)
Establishment
NameAddressID/FEIBusiness Operations
Aekyung Industrial Co., Ltd.690511126manufacture(67225-2024)

Revised: 5/2022