[de-listing] AEKYUNG LUNA LONG LASTING TIP CONCEALER BIG LIGHT BEIGE 67225-6801-1

AEKYUNG LUNA LONG LASTING TIP CONCEALER BIG LIGHT BEIGE by

Drug Labeling and Warnings

AEKYUNG LUNA LONG LASTING TIP CONCEALER BIG 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]

AEKYUNG LUNA LONG LASTING TIP CONCEALER BIG 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] AEKYUNG LUNA LONG LASTING TIP CONCEALER BIG LIGHT BEIGE
67225-6801-1

Active ingredient

Titanium Dioxide 22.68 %....................................................sunscreen

Inactive ingredients

Water, Cyclopentasiloxane, Phenyl Trimethicone, Talc, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, PVP, Niacinamide, PEG-10 Dimethicone, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Sodium Chloride, Disteardimonium Hectorite, Triethoxycaprylylsilane, Aluminum Hydroxide, Stearic Acid, p-Anisic Acid, Dimethicone, Glyceryl Caprylate, Adenosine, Centella Asiatica Extract, Portulaca Oleracea Extract, Anthemis Nobilis Flower Extract, Vitex Agnus Castus Extract, Hippophae Rhamnoides Fruit Extract, Butylphenyl Methylpropional, Fragrance, Iron Oxide Yellow(CI 77492), Iron Oxide Red(CI 77491), Iron Oxide Black(CI 77499)

AEKYUNG LUNA LONG LASTING TIP CONCEALER BIG LIGHT BEIGE 
titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-6801
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	9.072 g  in 40 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
CHASTE TREE (UNII: 433OSF3U8A)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
STEARIC ACID (UNII: 4ELV7Z65AP)
ADENOSINE (UNII: K72T3FS567)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
DIMETHICONE (UNII: 92RU3N3Y1O)
PURSLANE (UNII: M6S840WXG5)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
TALC (UNII: 7SEV7J4R1U)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
HIPPOPHAE RHAMNOIDES FRUIT (UNII: AVL0R9111T)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
NIACINAMIDE (UNII: 25X51I8RD4)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-6801-1	1 in 1 BOX	10/28/2020
1		40 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/28/2020	03/20/2023

Labeler - Aekyung Industrial Co., Ltd. (690511126)

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Industrial Co., Ltd.		690511126	manufacture(67225-6801)

Revised: 3/2023

Document Id: f765c45a-a564-9215-e053-6394a90a25d8

34390-5

Set id: b2b63e55-186b-43e2-e053-2995a90abeec

Version: 3

Effective Time: 20230321