[de-listing] [03 PURPLE] AGE 20s SIGNATURE ESSENCE COVER TONE-UP BASE 67225-2023-1

AGE20s SIGNATURE ESSENCE COVER TONE-UP BASE 03 PURPLE by

Drug Labeling and Warnings

AGE20s SIGNATURE ESSENCE COVER TONE-UP BASE 03 PURPLE 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 03 PURPLE- 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] [03 PURPLE] AGE 20s SIGNATURE ESSENCE COVER TONE-UP BASE
67225-2023-1

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, Vaccinium Angustifolium (Blueberry) Fruit Extract, Euterpe Oleracea Fruit Extract, Sambucus Nigra Fruit Extract, Manganese Violet (CI 77742)

AGE20s SIGNATURE ESSENCE COVER TONE-UP BASE 03 PURPLE

AGE20S SIGNATURE ESSENCE COVER TONE-UP BASE 03 PURPLE 
ethylhexyl methoxycinnamate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67225-2023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 40 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.896 g  in 40 mL
Inactive Ingredients
Ingredient NameStrength
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
ACAI (UNII: 46AM2VJ0AW)  
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)  
MANGANESE VIOLET (UNII: 72M48QQV8Q)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67225-2023-11 in 1 BOX11/09/2020
140 mL in 1 CONTAINER; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35211/09/202003/20/2023
Labeler - Aekyung Industrial Co., Ltd. (690511126)
Establishment
NameAddressID/FEIBusiness Operations
Aekyung Industrial Co., Ltd.690511126manufacture(67225-2023)

Revised: 3/2023