Label: HYDRABOOST MOISTURIZER SPF 30- avobenzone, homosalate, octisalate, and octocrylene 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 January 11, 2023

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Avobenzone 3%sunscreen
    Homosalate 8%sunscreen
    Octisalate 5%sunscreen
    Octocrylene 6%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 measure 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 (Aqua), Pentylene Glycol, Glyceryl Stearate, PEG-100 Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Methyldihydrojasmonate, Glycerin, Persea Gratissima (Avocado) Oil, Squalane, Hydrogenated Vegetable Oil, Hydrolyzed Hyaluronic Acid, Sodium Hyaluronate, Acetyl Hexapeptide-8, Palmitoyl Tripeptide-1, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-38, Tamarindus Indica Seed Polysaccharide, Centella Asiatica Extract, Aloe Barbadensis Leaf Juice, Panthenol, Hamamelis Virginiana (Witch Hazel) Water, Tocopherol, Carica Papaya (Papaya) Fruit Extract, Dioscorea Villosa (Wild Yam) Root Extract, Camellia Sinensis Leaf Extract, Morus Alba Bark Extract, Sodium Lactate, Benzoic Acid, Linolenic Acid, Linoleic Acid, Hydrolyzed Rice Protein, Glycine Soja (Soybean) Protein, Proline, Glycine, Cetearyl Alcohol, Polyethylene, Carrageenan, Trehalose, Sodium PCA, Carbomer, Urea, Superoxide Dismutase, Allantoin, Glucose, Sodium Chloride, Hydroxypropyl Cyclodextrin, Maltose, Fructose, Xanthan Gum, Ethylhexylglycerin, Trisodium EDTA, Polysorbate 20, Citric Acid, Sodium Hydroxide, Potassium Sorbate, Butylene Glycol, Phenoxyethanol

  • Other Information

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

    800-914-6000 9-5pm EST, Monday- Friday

  • PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

    m-61®
    powerful skincare

    Hydraboost
    Moisturizer
    SPF 30

    HYDRATING PEPTIDE
    AND VITAMIN B5
    MOISTURIZER

    BROAD SPECTRUM
    SPF30 SUNSCREEN

    Peptide-packed vitamin B5
    hydrating and firming
    daily moisturizer with
    SPF30, tamarind & aloe

    all skin types

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

    50 mL e 1.7 FL. OZ.

    PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    HYDRABOOST MOISTURIZER SPF 30 
    avobenzone, homosalate, octisalate, and octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72203-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE80 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE60 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    JOJOBA OIL (UNII: 724GKU717M)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SQUALANE (UNII: GW89575KF9)  
    CORN OIL (UNII: 8470G57WFM)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O)  
    CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    PAPAYA (UNII: KU94FIY6JB)  
    DIOSCOREA VILLOSA TUBER (UNII: IWY3IWX2G8)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MORUS ALBA BARK (UNII: 7O71A48NDP)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    (2-CHLOROPHENYL)METHYL 4-HYDROXYBENZOATE (UNII: 7910S1F5QK)  
    LINOLENIC ACID (UNII: 0RBV727H71)  
    RICE BRAN (UNII: R60QEP13IC)  
    SOYBEAN (UNII: L7HT8F1ZOD)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    GLYCINE (UNII: TE7660XO1C)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    TREHALOSE (UNII: B8WCK70T7I)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    UREA (UNII: 8W8T17847W)  
    SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
    ALLANTOIN (UNII: 344S277G0Z)  
    DEXTROSE, UNSPECIFIED FORM (UNII: IY9XDZ35W2)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    HYDROXYPROPYL BETADEX (UNII: 1I96OHX6EK)  
    MALTOSE, UNSPECIFIED FORM (UNII: XJ6S9RV06F)  
    FRUCTOSE (UNII: 6YSS42VSEV)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    EDETATE TRISODIUM (UNII: 420IP921MB)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72203-001-011 in 1 CARTON05/20/2018
    150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart35205/20/2018
    Labeler - Bluemercury (097435361)