Label: FRUDIA BLUEBERRY HYDRATING AIR FIT SUNSCREEN- octocrylene, homosalate, octisalate, avobenzone cream

  • NDC Code(s): 71017-001-01, 71017-001-02
  • Packager: WELCOS CO.,LTD.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 27, 2024

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

  • DOSAGE & ADMINISTRATION

    - Apply liberally 15 minutes before sun exposure. Reapply at least every two hours
    - 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
    - Ask a doctor to use for children under 6 months

  • ACTIVE INGREDIENT

    Octocrylene 9.00%

    Homosalate 7.30%

    Octisalate 4.70%

    Avobenzone 2.70%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • WARNINGS

    For external use only

    Do not use on damaged or broken skin

    Stop using and ask a doctor if rash occurs

    When using this product, keep out of eyes. Rinse with water to remove.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Water, Butyloctyl Salicylate, Niacinamide, Dicaprylyl Carbonate, Dipropylene Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Poly C10-30 Alkyl Acrylate, Sorbitan Olivate, Polymethylsilsesquioxane, Vaccinium Angustifolium (Blueberry) Fruit Extract, Benzyl Glycol, Glyceryl Stearate SE, Panthenol, Carbomer, Arginine, Ganoderma Lucidum (Mushroom) Stem Extract, Tocopheryl Acetate, Glycerin, Glyceryl Glucoside, Disodium EDTA, Ethylhexylglycerin, Xanthan Gum, Hydroxypropyl Methylcellulose Stearoxy Ether, Adenosine, Caprylic/Capric Triglyceride, Propanediol, Sodium Hyaluronate Crosspolymer, Hydrogenated lecithin, Hydrolyzed Glycosaminoglycans, 1,2-Hexanediol, Sodium Hyaluronate, Tocopherol, Hydrolyzed Hyaluronic Acid, Phytosterols, Hyaluronic Acid, Fragrance

  • OTHER SAFETY INFORMATION

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    FRUDIA BLUEBERRY HYDRATING AIR FIT SUNSCREEN 
    octocrylene, homosalate, octisalate, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71017-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE73 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE47 mg  in 1 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE27 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    BEHENYL ACRYLATE POLYMER (UNII: D64PM5UT4U)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
    ETHYLENE GLYCOL MONOBENZYL ETHER (UNII: 06S8147L47)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    ARGININE (UNII: 94ZLA3W45F)  
    GANODERMA LUCIDUM STEM (UNII: U8PA41532G)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL GLUCOSIDE (UNII: 3297VXM8Z6)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    HYPROMELLOSE 2208 0.45% STEAROXY ETHER (UNII: MG58AH4FJ8)  
    ADENOSINE (UNII: K72T3FS567)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71017-001-021 in 1 CARTON04/27/2024
    1NDC:71017-001-0150 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02004/27/2024
    Labeler - WELCOS CO.,LTD. (689131584)
    Registrant - WELCOS CO.,LTD. (689131584)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebom Co., Ltd.695951708manufacture(71017-001)