[de-listing] [67225-0624-2] AGE20'S SIGNATURE ESSENCE COVER PACT MOISTURE 21 LIGHT BEIGE

AGE20s SIGNATURE ESSENCE COVER PACT MOISTURE 21 LIGHT BEIGE by

Drug Labeling and Warnings

AGE20s SIGNATURE ESSENCE COVER PACT MOISTURE 21 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]

AGE20S SIGNATURE ESSENCE COVER PACT MOISTURE 21 LIGHT BEIGE- titanium dioxide, ethylhexyl methoxycinnamate, octocrylene 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] [67225-0624-2] AGE20'S SIGNATURE ESSENCE COVER PACT MOISTURE 21 LIGHT BEIGE

Active ingredients

Titanium Dioxide 9.09 %............................ sunscreen

Ethylhexyl Methoxycinnamate 7 %............ sunscreen
Octocrylene 4 %......................................... sunscreen

Inactive ingredients

Betula Platyphylla Japonica Bark Extract, Betula Platyphylla Japonica Juice, Dipropylene Glycol,
Diethylamino Hydroxybenzoyl Hexyl Benzoate, Phenyl Trimethicone, Aloe Barbadensis Leaf Extract,
Hydrogenated Poly(C6-14 Olefin), Niacinamide, Euphorbia Cerifera (Candelilla) Wax, Propanediol,
Dimethicone, Cyclopentasiloxane, Butylene Glycol, 1,2-Hexanediol, Squalane, Cyclohexasiloxane,
Cetyl PEG/PPG-10/1 Dimethicone, Polymethylsilsesquioxane, Glycerin, Sodium Glutamate,

VP/Hexadecene Copolymer, Aluminum Hydroxide, C30-45 Alkyl Methicone, p-Anisic Acid,
Stearic Acid, Dimethicone/PEG-10/15 Crosspolymer, C30-45 Olefin, Glyceryl Caprylate,
Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Panthenol, Tocopheryl Acetate,
Ceramide NP, Stearyl Heptanoate, Adenosine, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA,
Cholesterol, Triethoxycaprylylsilane, Water, Hydrolyzed Hyaluronic Acid, Polyhydroxystearic Acid,
Sodium Hyaluronate, Haematococcus Pluvialis Extract, Linoleic Acid, Astaxanthin, Glycine Soja (Soybean) Oil,
Ethylhexylglycerin, Lecithin, Aphanothece Sacrum Polysaccharide, sh-Polypeptide-60, Fragrance, Benzyl Salicylate,
Butylphenyl Methylpropional, Linalool, Benzyl Benzoate, Alpha-Isomethyl Ionone,
Iron oxides Yellow(CI 77492), Iron oxides Red(CI 77491), Iron oxides Black(CI 77499), Ultramarines(CI 77007)

AGE20S SIGNATURE ESSENCE COVER PACT MOISTURE 21 LIGHT BEIGE 
titanium dioxide, ethylhexyl methoxycinnamate, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-0624
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.2726 g  in 14 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.98 g  in 14 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.56 g  in 14 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)
CERAMIDE NP (UNII: 4370DF050B)
STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)
CHOLESTEROL (UNII: 97C5T2UQ7J)
HAEMATOCOCCUS PLUVIALIS (UNII: 31T0FF0472)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
DIMETHICONE (UNII: 92RU3N3Y1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
C30-45 OLEFIN (UNII: 6DWD51M0O8)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
PROPANEDIOL (UNII: 5965N8W85T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
SQUALANE (UNII: GW89575KF9)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
PANTHENOL (UNII: WV9CM0O67Z)
MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)
SOYBEAN OIL (UNII: 241ATL177A)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
BENZYL BENZOATE (UNII: N863NB338G)
FERRIC OXIDE RED (UNII: 1K09F3G675)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ASTAXANTHIN (UNII: 8XPW32PR7I)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
ULTRAMARINE BLUE (UNII: I39WR998BI)
BETULA PLATYPHYLLA VAR. JAPONICA RESIN (UNII: 1B33PG6N4K)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
CANDELILLA WAX (UNII: WL0328HX19)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
HYALURONIC ACID (UNII: S270N0TRQY)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
BETULA PLATYPHYLLA VAR. JAPONICA BARK (UNII: ZF70YKN0YO)
HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)
NIACINAMIDE (UNII: 25X51I8RD4)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-0624-2	2 in 1 BOX	06/24/2020
1		14 g in 1 CASE; 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	06/24/2020	03/20/2023

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

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

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Industrial Co., Ltd.		690511126	manufacture(67225-0624)

Revised: 3/2023

Document Id: f765be04-761e-81ca-e053-6294a90ae8bc

34390-5

Set id: a8cfa099-50cf-be0e-e053-2995a90ae784

Version: 2

Effective Time: 20230321