Label: HYDRA BEAUTE SPF 15- avobenzone, homosalate, octinoxate, octisalate, octocrylene cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 19, 2023

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  • Drug Facts

  • Active ingredients

    Avobenzone 2.85%

    Homosalate 5.00%

    Octinoxate 7.00%

    Octisalate 3.00%

    Octocrylene 9.00%

    Purpose

    Sunscreen

  • Uses

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

    • Apply liberally 15 minutes before sun exposure.
    • Reapply at least every 2 hours.
    • Use a water resistant sunscreen if swimming or sweating.
    • 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 or higher and other sun protection measures including: Sun Protection Measures:
    • Children under 6 months: Ask a doctor.

    - Limit time in the sun, especially from 10 a.m. to 2 p.m.

    - Wear long-sleeve shirts, pants hats, and sunglasses.

  • Other information

    • Protect this product from excessive heat and direct sun.
    • Store below 30°C/86°F.
  • Inactive ingredients

    Water/Eau (Aqua), Glycerin, Cetyl Alcohol, Caprylic/Capric Triglyceride, Pentylene Glycol, Sodium Stearoyl Glutamate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Polymethylsilsesquioxane, Caprylyl Methicone, HDI/Trimethylol Hexyllactone Crosspolymer, Hydrogenated Lecithin, Palmitic Acid, Propylene Glycol, Ethylhexylglycerin, Bisabolol, Oxidized Corn Oil, Tocopheryl Acetate, Stearalkonium Hectorite, Fragrance (Parfum), Xanthan Gum, C30-45 Alkyl Cetearyl Diemthicone Crossspolymer, Betaine, Propylene Carbonate, Polysorbate 60, Sorbitan Isostearate, Disodium EDTA, Laminaria Ochroleuca Extract, Pectin, Butylene Glycol, Sucrose, Glyceryl Acrylate/Acrylic Acid Copolymer, Capryloyl Glycine, Sodium Hyaluronate, Red 4 (CI 14700). 01

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    HYDRA BEAUTE SPF 15 
    avobenzone, homosalate, octinoxate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54181-009
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE28.5 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE50 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE90 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
    HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BETAINE (UNII: 3SCV180C9W)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    PECTIN (UNII: 89NA02M4RX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SUCROSE (UNII: C151H8M554)  
    CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54181-009-501 in 1 BOX01/01/2019
    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 DrugM02001/01/2019
    Labeler - Guinot (763667185)
    Establishment
    NameAddressID/FEIBusiness Operations
    Guinot763667185manufacture(54181-009)
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