[de-listing] [02 GREEN] AGE 20s SIGNATURE ESSENCE COVER TONE-UP BASE 67225-2022-1

AGE20s SIGNATURE ESSENCE COVER TONE-UP BASE 02 GREEN by

Drug Labeling and Warnings

AGE20s SIGNATURE ESSENCE COVER TONE-UP BASE 02 GREEN 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 TONE-UP BASE 02 GREEN- ethylhexyl methoxycinnamate, 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] [02 GREEN] AGE 20s SIGNATURE ESSENCE COVER TONE-UP BASE
67225-2022-1

Active ingredients Purpose

Ethylhexyl Methoxycinnamate 5.00 %..................................sunscreen
Titanium Dioxide 4.74 %......................................................sunscreen

Inactive ingredients Betula Platyphylla Japonica Bark Extract, Cyclopentasiloxane, Glycerin, Betula Platyphylla Japonica Juice, Butylene Glycol, Alcohol, Diphenylsiloxy Phenyl Trimethicone, Isodecyl Neopentanoate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Cyclohexasiloxane, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Niacinamide, Dimethicone, Isononyl Isononanoate, PEG-9 Polydimethylsiloxyethyl Dimethicone, Sodium Chloride, 1,2-Hexanediol, Methyl Methacrylate Crosspolymer, Panthenol, Sodium Glutamate, Tocopheryl Acetate, p-Anisic Acid, Aluminum Hydroxide, Stearic Acid, Glyceryl Caprylate, Fragrance, Disteardimonium Hectorite, Sodium Hyaluronate, Propylene Carbonate, Triethoxycaprylylsilane, Adenosine, Alumina, Ceramide NP, Disodium EDTA, Cholesterol, Hydrolyzed Hyaluronic Acid, Glyceryl Glucoside, Water, Linoleic Acid, VP/Hexadecene Copolymer, Tocopherol, Rosmarinus Officinalis (Rosemary) Leaf Extract, Centella Asiatica Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Chromium Oxide Greens (CI 77288)

AGE20S SIGNATURE ESSENCE COVER TONE-UP BASE 02 GREEN 
ethylhexyl methoxycinnamate, titanium dioxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67225-2022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	2 g  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.896 g  in 40 mL

Inactive Ingredients
Ingredient Name	Strength
ROSEMARY (UNII: IJ67X351P9)
MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)
CHROMIC OXIDE (UNII: X5Z09SU859)
CENTELLA ASIATICA (UNII: 7M867G6T1U)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
ALUMINUM OXIDE (UNII: LMI26O6933)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
CERAMIDE NP (UNII: 4370DF050B)
STEARIC ACID (UNII: 4ELV7Z65AP)
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
NIACINAMIDE (UNII: 25X51I8RD4)
DIMETHICONE (UNII: 92RU3N3Y1O)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALCOHOL (UNII: 3K9958V90M)
POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q)
BETULA PLATYPHYLLA RESIN (UNII: 1B33PG6N4K)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
CHOLESTEROL (UNII: 97C5T2UQ7J)
TOCOPHEROL (UNII: R0ZB2556P8)
BETULA PLATYPHYLLA BARK (UNII: ZF70YKN0YO)
GLYCERIN (UNII: PDC6A3C0OX)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
ADENOSINE (UNII: K72T3FS567)
WATER (UNII: 059QF0KO0R)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67225-2022-1	1 in 1 BOX	11/09/2020
1		40 mL in 1 CONTAINER; 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	11/09/2020	03/20/2023

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

Establishment
Name	Address	ID/FEI	Business Operations
Aekyung Industrial Co., Ltd.		690511126	manufacture(67225-2022)

Revised: 3/2023

Document Id: f765b365-2be7-ac55-e053-6294a90a1d44

34390-5

Set id: b3a92cf8-771d-a3af-e053-2a95a90a6953

Version: 2

Effective Time: 20230321