Label: AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN(TWIN PACK)- octocrylene, homosalate, octisalate, avobenzone cream

  • NDC Code(s): 67225-5034-1, 67225-5034-2
  • Packager: Aekyung Industrial Co., Ltd.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated August 14, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Avobenzone 2.70%

    Homosalate 7.00%

    Octisalate 4.50%

    Octocrylene 9.00%

  • 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

    ■ on damaged skin or broken skin

  • WHEN USING

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

  • STOP USE

    and ask a doctor if ■ rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • INACTIVE INGREDIENT

    Water, Propanediol, Butyloctyl Salicylate, Polyglyceryl-3 Distearate, Silica, Microcrystalline Cellulose, C13-15 Alkane, Panthenol, Camellia Sinensis Leaf Extract, Aloe Barbadensis Leaf Extract, Polyglycerin-3, Poly C10-30 Alkyl Acrylate, Dipropylene Glycol, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Benzotriazolyl Dodecyl p-Cresol, Hydroxyacetophenone, Sodium Stearoyl Glutamate, Butylene Glycol, Allantoin, Ammonium Polyacryloyldimethyl Taurate, Cetearyl Alcohol, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Glycol, Glycerin, Disodium EDTA, Oleic Acid, Caprylhydroxamic Acid, Ethanol, Cellulose Gum, 1,2-Hexanediol, Oryza Sativa (Rice) Bran Extract, Scutellaria Baicalenesis Root Extract, Tris(Tetramethylhy- droxypiperidinol) Citrate, t-Butyl Alcohol, Ascorbic Acid, Niacinamide, Tocopheryl Acetate, Saccharomyces Cerevisiae Extract, Hyaluronic Acid, Ceramide NP

  • OTHER SAFETY INFORMATION

    ■ Protect the product in the container from excessive heat and avoid storing it under direct sun.

    ■ 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 liberally 15 minutes before sun exposure.

    ■ Children under 6 months of age: Ask a doctor.

    ■ Reapply at least every 2 hours.

    ■ Use a water-resistant sunscreen if swimming or sweating

    Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. Todecrease 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 10 a.m. - 2 p.m.

    ■ Wear long-sleeved shirts, pants, hats, and sunglasses.

  • PRINCIPAL DISPLAY PANEL

    Principal Display

  • INGREDIENTS AND APPEARANCE
    AGE20S UV DEFENSE HYDRO CALMING SUNSCREEN(TWIN PACK) 
    octocrylene, homosalate, octisalate, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67225-5034
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE3.5 g  in 50 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE4.5 g  in 50 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.25 g  in 50 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.35 g  in 50 g
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    BENZOTRIAZOLYL DODECYL P-CRESOL (UNII: 298PX4M11X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CERAMIDE NP (UNII: 4370DF050B)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALCOHOL (UNII: 3K9958V90M)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    RICE BRAN (UNII: R60QEP13IC)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (UNII: F01RIY4371)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TRIS(TETRAMETHYLHYDROXYPIPERIDINOL) CITRATE (UNII: 7NW772I64Y)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    WATER (UNII: 059QF0KO0R)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    TERT-BUTYL ALCOHOL (UNII: MD83SFE959)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    OLEIC ACID (UNII: 2UMI9U37CP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67225-5034-22 in 1 BOX08/14/2024
    1NDC:67225-5034-150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/14/2024
    Labeler - Aekyung Industrial Co., Ltd. (690511126)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aekyung Industrial Co., Ltd.690511126manufacture(67225-5034)