De-listing Age 20s ESSENCE COVER PACT ORIGINAL PINK LATTE 23

Age 20s ESSENCE COVER PACT ORIGINAL PINK LATTE 23 by

Drug Labeling and Warnings

Age 20s ESSENCE COVER PACT ORIGINAL PINK LATTE 23 by is a Otc medication manufactured, distributed, or labeled by Aekyung Industrial Co., Ltd., Aekyung Ind. Co., Ltd._Chungyang Factory. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

AGE 20S ESSENCE COVER PACT ORIGINAL PINK LATTE 23- age 20s foundation 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 Age 20s ESSENCE COVER PACT ORIGINAL PINK LATTE 23

Active Ingredients: Titanium dioxide (8.86%), Ethylhexyl Methoxycinnamate (7%), Octocrylene (4%), Diethylamino Hydroxybenzoyl Hexyl Benzoate (3%)

Purpose Skin Protectant

Uses: Helps prevent sunburn

Keep out of reach of children

Use the product as directed.  Always close the cap after use.  Please do not crush or drop the products.  Please handle with care.

- Do not use the product if you experience the following symptoms.  May lead to worsening symptoms if you continue to use the product so please consult a dermatologist

  - If you experience red spots, swelling, itchiness or irritation

  - If you experience the symptoms above when exposed to direct sunlight

- Do not use on damaged skin or when suffering from eczema or dermatitis

- Do not consume.  Consult your physician immediately if swallowed

Apply the product on your skin with the included applicator by rubbing the product with the applicator and gently patting it on skin.  If in eyes, rinse immediately with running water.

- Avoid high/low temperatures and direct sunlight when storing
- Protect the product in the container from excessive heat and direct sun

Inactive Ingredients: Hyaluronic Acid, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate, Phenyl Trimethicone, Cyclopentasiloxane, Niacinamide, Euphorbia Cerifera (Candella) Wax, Dimethicone, Cyclohexasiloxane, Hydrogenated Polyisobulene, CI 77492, Silica, Cetyl PEG/PPG-10/1 Dimethicone, 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, CI 77491, Triethoxycaprylylsilane, Alumina, Butylene Glycol, Perfume, Synthetic Sapphire, CI 77499, Dipropylene Glycol, Cetearyl Nonanoate, Adenosine, Lavandula Angustifolia (Lavender) Extract, Origanum Vulgare Flower/Leaf/Stem Extract, Polymethylsilsesquioxane, Rosmarinus Officinalis (Rosemary) Extract, Thymus Vulgaris (Thyme) Extract, Water, Citrus Medica Limonum (Lemon) Fruit Extract, milk protein extract, Pearl Powder, Saussurea Involucrata Extract, Terminalia Ferdinandiana Fruit Extract, Yeast Ferment Extract, Aspergillus/Camellia Sinensis Leaf Extract Ferment Filtrate, Aureobasidium Pullalans Ferment Filtrate, Bifida Ferment Filtrate, Galactomyces Ferment Filtrate, Lactobacillus/Collagen Ferment Filtrate, Lactobacillus/Purica Granatum Fruit Juice Ferment Filtrate, Lactobacillus/Royal Jelly Ferment Filtrate, Lactobacillus/Soybean Extract Ferment Filtrate, Vitreoscilia Ferment, Glycerin, Madecassoside, Diamond Powder, Ruby Powder, Mica, Pentylene Glycol, 1,2-Hexanediol, Caprylyl Glycol, Hydroxyapatite, Carbomer, Sodium Lactate, Hydrogenated Lecithin, Phenoxyethanol, Polysorbate 20, Zinc Oxide, Palmitoyl Tripeptide-1, rh-Oligopeptide-1, Palmitoyl Tetrapeptide-7, Polymethyl Methacrylate, Ultramarines

Label

AGE 20S ESSENCE COVER PACT ORIGINAL PINK LATTE 23 
age 20s foundation cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 67225-0523
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.1075 g  in 12.5 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.875 g  in 12.5 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.5 g  in 12.5 g
Inactive Ingredients
Ingredient NameStrength
HYALURONIC ACID (UNII: S270N0TRQY)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
MICA (UNII: V8A1AW0880)  
C30-45 OLEFIN (UNII: 6DWD51M0O8)  
C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
NIACINAMIDE (UNII: 25X51I8RD4)  
CANDELILLA WAX (UNII: WL0328HX19)  
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
DISPERSE BLUE 3 (UNII: 8X7KL92596)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
CETEARYL NONANOATE (UNII: F6ZWV2F361)  
ADENOSINE (UNII: K72T3FS567)  
LAVANDULA ANGUSTIFOLIA WHOLE (UNII: 51217XIL5L)  
ORIGANUM VULGARE SUBSP. HIRTUM WHOLE (UNII: 38SNL0F81Z)  
POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
ROSMARINUS OFFICINALIS WHOLE (UNII: EA3289138M)  
THYMUS VULGARIS WHOLE (UNII: 8L72OKJ7II)  
WATER (UNII: 059QF0KO0R)  
LEMON (UNII: 24RS0A988O)  
CASEIN (UNII: 48268V50D5)  
PEARL (HYRIOPSIS CUMINGII) (UNII: A75L5FZ40U)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
YEAST (UNII: 3NY3SM6B8U)  
CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)  
AUREOBASIDIUM PULLULANS VAR. PULLUTANS (UNII: D1A2NG69CK)  
GLYCERIN (UNII: PDC6A3C0OX)  
MADECASSOSIDE (UNII: CQ2F5O6YIY)  
DIAMOND (UNII: 6GRV67N0U2)  
BASIC RED 51 (UNII: A7A946JJ6I)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
NEPIDERMIN (UNII: TZK30RF92W)  
PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
ULTRAMARINE BLUE (UNII: I39WR998BI)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 67225-0523-12 in 1 PACKAGE06/02/2017
112.5 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/02/201712/01/2019
Labeler - Aekyung Industrial Co., Ltd. (690511126)
Establishment
NameAddressID/FEIBusiness Operations
Aekyung Ind. Co., Ltd._Chungyang Factory690511126manufacture(67225-0523)

Revised: 12/2019
 
Aekyung Industrial Co., Ltd.