Label: AGE 20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUM- octinoxate, octocrylene, titanium dioxide cream

  • NDC Code(s): 67225-5022-1, 67225-5022-2
  • Packager: Aekyung Industrial Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated May 8, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Octinoxate 6.50 %

    Titanium Dioxide 5.12 %

    Octocrylene 3.00 %

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    ■ Helps prevent sunburn.
    ■ If used as directed with other sun protection measures ( See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    For external use only

  • DO NOT USE

    ■ damaged skin or broken skin.

  • WHEN USING

    this product ■ keep out of eyes. Rinse with water to remove.

  • STOP USE

    and ask a doctor ■ rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact poison control center right away.

  • OTHER SAFETY INFORMATION

    ■ Protect the product in this container from excessive heat and avoid storing it under direct sun. ■ Do not crush or drop product.■ Handle with care.■ Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

  • DOSAGE & ADMINISTRATION

    Directions
    ■ Apply the product on your skin with the included applicator by rubbing the product with the applicator and gently patting it on your skin.■ Apply liberally 15 minutes before sun exposure.
    Sun Protection Measures Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:■ Limit time in the sun, especially from 10a.m. - 2 p.m. ■ Wear long-sleeved shirts, pants, hats, and sunglasses.■ Children under 6 months of age: Ask a doctor. ■Reapply at least every 2 hours.■ Use a water-resistant sunscreen if swimming or sweating.

  • INACTIVE INGREDIENT


    Water, Betula Platyphylla Japonica Juice, Dipropylene Glycol, Pentaerythrityl Stearate/Caprate/Caprylate/Adipate, Phenyl Trimethicone, Polymethylsilsesquioxane, Hydrogenated Poly(C6-14 Olefin), Niacinamide, Euphorbia Cerifera (Candelilla) Wax, Dimethicone, Cyclopentasiloxane, Butylene Glycol, Aloe Barbadensis Leaf Extract, Squalane, Triisostearin, 1,2-Hexanediol, Cyclohexasiloxane, Propanediol, Cetyl PEG/PPG-10/1 Dimethicone, Aluminum Hydroxide, Sodium Glutamate, VP/Hexadecene Copolymer, C30-45 Alkyl Methicone, Stearic Acid, p-Anisic Acid, Dimethicone/PEG-10/15 Crosspolymer, C30-45 Olefin, Glyceryl Caprylate, Betula Platyphylla Japonica Bark Extract, Glycerin, Fragrance, Triethoxycaprylylsilane, Panthenol, Tocopheryl Acetate, Ceramide NP, Stearyl Heptanoate, Adenosine, Myristoyl/Palmitoyl Oxostearamide/Arachamide MEA, Cholesterol, Hydrolyzed Hyaluronic Acid, Polyhydroxystearic Acid, Sodium Hyaluronate, Lactobacillus Ferment Lysate, Linoleic Acid, BHT, Sodium Citrate, Boron Nitride, Tocopherol, Aphanothece Sacrum Polysaccharide, Glycine Soja (Soybean) Oil, Ethylhexylglycerin, Lecithin, Disodium EDTA, Sodium Ascorbyl Phosphate, sh-Polypeptide-60, Alpha-Isomethyl Ionone, Benzyl Benzoate, Benzyl Salicylate, Linalool, +/- may contain (Titanium Dioxide (CI 77891), Iron Oxide (CI 77491), Iron Oxide (CI 77492), Iron Oxide (CI 77499))

  • PRINCIPAL DISPLAY PANEL

    Principal Display

  • INGREDIENTS AND APPEARANCE
    AGE 20S SIGNATURE ESSENCE COVER PACT INTENSE COVER 27 MEDIUM 
    octinoxate, octocrylene, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67225-5022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE0.7168 g  in 14 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE0.42 g  in 14 g
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE0.91 g  in 14 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)  
    HYDROGENATED POLY(C6-14 OLEFIN; 2 CST) (UNII: P0TX083987)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    ADENOSINE (UNII: K72T3FS567)  
    PENTAERYTHRITYL STEARATE (UNII: T9BY3B181Z)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    CERAMIDE NP (UNII: 4370DF050B)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    C30-45 OLEFIN (UNII: 6DWD51M0O8)  
    TRIISOSTEARIN (UNII: 71503RH8KG)  
    MONOSODIUM GLUTAMATE (UNII: W81N5U6R6U)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    STEARYL HEPTANOATE (UNII: 2M4UGL1NCN)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    WATER (UNII: 059QF0KO0R)  
    POLYHYDROXYSTEARIC ACID STEARATE (UNII: 8KQ7I65XZE)  
    LINOLEIC ACID (UNII: 9KJL21T0QJ)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
    C30-45 ALKYL METHICONE (UNII: NFX970DSI2)  
    BETULA PLATYPHYLLA RESIN (UNII: 1B33PG6N4K)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    SQUALANE (UNII: GW89575KF9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MYRISTOYL/PALMITOYL OXOSTEARAMIDE/ARACHAMIDE MEA (UNII: 1211AIM8G7)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67225-5022-21 in 1 BOX02/16/2024
    1NDC:67225-5022-140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/16/2024
    Labeler - Aekyung Industrial Co., Ltd. (690511126)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aekyung Industrial Co., Ltd.690511126manufacture(67225-5022)