Label: ANUA HEARTLEAF SILKY MOISTURE MILD SUNSCREEN- avobenzone, homosalate, octisalate, octocrylene cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated September 19, 2024

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

  • Drug Facts

    Active Ingredients

    Avobenzone 3.0%

    Homosalate 7.3%

    Octisalate 5.0%

    Octocrylene 9.0%

    Purpose

    Sunscreen

    Uses

    ■ 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 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 product is swallowed, get medical help or contact a Poison Control Center right away.

    Directions

    For sunscreen use:

    ■ apply liberally 15 minutes before sun exposure

    ■ children under 6 months of age: Ask a doctor

    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 10 a.m.- 2 p.m.

    ■ wear long-sleeved shirts, pants, hats, and sunglasses

    ■ reapply at least every 2 hours

    ■ use a water resistant sunscreen if swimming or sweating

    Other Information

    ■ Protect the product in this container from excessive heat and direct sun

    Inactive ingredients

    Water, Propanediol, Butyloctyl Salicylate, Ethylhexyl Methoxycrylene, Nylon-12, Silica, Sodium Acrylates Crosspolymer-2, 1,2-Hexanediol, Pentylene Glycol, Polyglyceryl-3 Distearate, Hydroxyethyl Urea, Cetearyl Olivate, Potassium Cetyl Phosphate, Butylene Glycol, Sorbitan Olivate, Cetyl Alcohol, Houttuynia Cordata Extract, Carbomer, Glycerin, Panthenol, Xanthan Gum, Glyceryl Stearate Citrate, Ethylhexylglycerin, Disodium EDTA, Acetyl Glucosamine, Sodium Hyaluronate, Cryptomeria Japonica Leaf Extract, Nelumbo Nucifera Leaf Extract, Saccharomyces Ferment, Hydroxyacetophenone, Cynanchum Atratum Extract, Sodium Hyaluronate Crosspolymer, Althaea Rosea Flower Extract, Tocopherol, Dimethylsilanol Hyaluronate, Hydrolyzed Hyaluronic Acid, Hydrolyzed Sodium Hyaluronate, Caprylyl Glycol, Hyaluronic Acid, Potassium Hyaluronate, Hydroxypropyltrimonium Hyaluronate, Sodium Hyaluronate Dimethylsilanol, Sodium Acetylated Hyaluronate

    Questions ?

    +82 1688-9407

    Contact information

    : www.anua.us

  • PACKAGE LABEL

    ANUA HEARTLEAF SILKY MOISTURE MILD SUNSCREEN

  • INGREDIENTS AND APPEARANCE
    ANUA HEARTLEAF SILKY MOISTURE MILD SUNSCREEN 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84610-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE73 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    NYLON-12 (UNII: 446U8J075B)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SODIUM ACRYLATES CROSSPOLYMER-2 (UNII: D3HPR4WW6F)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    DIMETHYLSILANOL HYALURONATE (UNII: Z853O1D4TE)  
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    N-ACETYLGLUCOSAMINE (UNII: V956696549)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CRYPTOMERIA JAPONICA LEAF (UNII: SCM4971GZQ)  
    NELUMBO NUCIFERA LEAF (UNII: 60C608DPVT)  
    ALCEA ROSEA FLOWER (UNII: 1250O8MKPZ)  
    GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    POLYGLYCERYL-3 DISTEARATE (UNII: ZI1LK470XV)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84610-100-011 in 1 CARTON09/12/2024
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/12/2024
    Labeler - The Founders Inc. (695015866)
    Registrant - The Founders Inc. (695015866)