Label: HYDRABOOST OIL-FREE SUNSCREEN SPF 40- 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 16, 2021

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Homosalate 14.5%sunscreen
    Ethylhexyl Salicylate 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, HDI/PPG/Polycaprolactone Crosspolymer, Butyloctyl Salicylate, Propanediol, Sorbeth-30 Tetraisostearate, Isododecane, VP/Eicosene Copolymer, VP/Acrylates/Lauryl Methacrylate Copolymer, Triacontanyl PVP, VP/Hexadecene Copolymer, Alcohol, Acetyl Hexapeptide-8, Panthenol, Sodium Hyaluronate, Aloe Barbadensis Leaf Extract, Tamarindus Indica Fruit Extract, Centella Asiatica Extract, Potassium Sorbate, Potassium Hydroxide, Phenoxyethanol, Sorbitan Sesquiisostearate, PPG-8 Ceteth-20, Acrylates/Beheneth-25 Methacrylate Copolymer, Dipropylene Glycol, Disodium EDTA, Hydroxyethylcellulose

  • 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 - 50 mL Bottle Carton

    m-61®
    powerful skincare

    Hydraboost
    Oil-Free
    Sunscreen
    SPF 40

    BROAD SPECTRUM SPF 40
    HYDRATING PEPTIDE AND
    VITAMIN B5 REEF SAFE
    SUNSCREEN

    Lightweight SPF 40 with
    a power-packed peptide,
    vitamin B5 & tamarind

    all skin types

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

    50 mL ℮ 1.7 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    HYDRABOOST OIL-FREE SUNSCREEN SPF 40 
    homosalate, octisalate, and avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72203-015
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE145 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)  
    Butyloctyl Salicylate (UNII: 2EH13UN8D3)  
    Propanediol (UNII: 5965N8W85T)  
    Isododecane (UNII: A8289P68Y2)  
    Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3)  
    Tricontanyl Povidone (UNII: N0SS3Q238D)  
    Vinylpyrrolidone/Hexadecene Copolymer (UNII: KFR5QEN0N9)  
    Alcohol (UNII: 3K9958V90M)  
    Acetyl Hexapeptide-8 (UNII: L4EL31FWIL)  
    Panthenol (UNII: WV9CM0O67Z)  
    Hyaluronate Sodium (UNII: YSE9PPT4TH)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Tamarind Juice (UNII: 5P6V8403U4)  
    Centella Asiatica Whole (UNII: 7M867G6T1U)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Sorbitan Sesquiisostearate (UNII: VU97D01BF9)  
    Ppg-8-Ceteth-20 (UNII: MAL0SND89Q)  
    Dipropylene Glycol (UNII: E107L85C40)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Hydroxyethyl Cellulose, Unspecified (UNII: T4V6TWG28D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72203-015-011 in 1 CARTON04/01/2021
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35204/01/2021
    Labeler - Bluemercury (097435361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Biogenesis, Inc.069117328MANUFACTURE(72203-015)
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