Label: HYDRABOOST BODY SUNSCREEN SPF 30- homosalate, octisalate, and avobenzone lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 21, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Homosalate 15%sunscreen
    Octisalate 5%sunscreen
    Avobenzone 3%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 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.
    • 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 or higher and other sun protection measures including:
      • Limit time in the sun, especially from 10am-2pm.
      • Wear long-sleeve shirts, pants, hats & sunglasses.
    • Children under 6 months of age:
      Ask a doctor.
  • Inactive Ingredients

    Water, Octyldodecyl Neopentanoate, Glycerin, Propanediol, Butyloctyl Salicylate, Sorbeth-30 Tetraisostearate, Isododecane, Alcohol, VP/Eicoseine Copolymer, Acetyl Hexapeptide-8, Nanochloropsis Oculata Extract, Panthenol, Chondrus Crispus Extract, Aloe Barbadensis Leaf Juice, Centella Asiatica Extract, Sodium Hyaluronate, Tamarindus Indica Fruit Extract, Dipropylene Glycol, Phenoxyethanol, Gluconolactone, Sodium Benzoate, Sorbitan Sesquiisostearate, PPG-8 Ceteth-20, Acrylates/Beheneth-25 Methacrylate Copolymer, Disodium EDTA, Potassium Hydroxide, Hydroxyethylcellulose, Acetic Acid, Potassium Sorbate

  • Other Information

    • Protect the product in this container from excessive heat and direct sun.
  • Questions?

    800-294-7700 9-5pm EST, Monday-Friday

  • PRINCIPAL DISPLAY PANEL - 150 mL Tube Carton

    m-61®
    powerful skincare

    Hydraboost
    Body Sunscreen
    SPF 30

    BROAD SPECTRUM SPF 30
    HYDRATING AND FIRMING
    ALGAE EXTRACT &
    PEPTIDE SUNSCREEN

    SPF 30 with a power-packed
    peptide, algae extract and
    vitamin B5

    all skin types

    100% paraben-free
    100% synthetic fragrance-free
    dermatologist tested
    allergy tested

    150 mL/5.07 FL. OZ.

    Principal Display Panel - 150 mL Tube Carton
  • INGREDIENTS AND APPEARANCE
    HYDRABOOST BODY SUNSCREEN SPF 30 
    homosalate, octisalate, and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72203-018
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE150 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
    WATER (UNII: 059QF0KO0R)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    ISODODECANE (UNII: A8289P68Y2)  
    ALCOHOL (UNII: 3K9958V90M)  
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CENTELLA ASIATICA TRITERPENOIDS (UNII: 4YS74Q4G4J)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    TAMARIND JUICE (UNII: 5P6V8403U4)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITAN SESQUIISOSTEARATE (UNII: VU97D01BF9)  
    PPG-8-CETETH-20 (UNII: MAL0SND89Q)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    ACETIC ACID (UNII: Q40Q9N063P)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72203-018-011 in 1 CARTON04/15/2023
    1150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/15/2023
    Labeler - Bluemercury (097435361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biogenesis, Inc.069117328MANUFACTURE(72203-018)
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