Label: GLYTONE HYDRA LIPID UV MINERAL SUNSCREEN SPF 40 PLUS- zinc oxide, titanium dioxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated April 29, 2024

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  • Drug Facts

  • Purpose

    Sunscreen

  • Active ingredients

    Titanium Dioxide 2%

    Zinc Oxide 1%

  • 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 eyes 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.

    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 10 a.m. - 2 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under 6 months: Ask a doctor
  • Other information

    • Protect this product from excessive heat and direct sun.
  • Inactive ingredients

    Water, Butyloctyl Salicylate, Octyldodecyl Neopentanoate, Ethylhexyl Isononanoate, Polyester-7, Glycerin, Neopentyl Glycol, Diheptanoate, Cetyl Alcohol, Glyceryl Stearate, Squalane, Phenoxyethanol, PEG-75 Stearate, Bisabolol, Hydrolyzed Sodium Hyaluronate, Pyrus Malus (Apple) Fruit Extract, C12-15 Alkyl Benzoate, Lysolecithin, Sclerotlum Gum, Dimethiconol/Octylsilsesquioxane/Silicate Crosspolymer, Allantoin, Ceteth-20, Steareth-20, Caprylyl Glycol, Triceteareth-4 Phosphate. Pullulan. Xanthan Gum, Sodium Hyaluronate, Dimethiconol/Propylsilsesquioxane/Silicate Crosspolymer
    Disodium EDTA, Ethylhexylglycerin, Hexylene Glycol, Dicrateria Rotunda Oil, Ruttnera Lamellosa Oil, Lecithin, Silica, Camellia Sinensis Leaf Extract, Avena Sativa (Oat) Kernel Extract, Sodium Ascorbate, Potassium Sorbate, Tocopherol.

  • Questions or comments?

    visit www.glytone.com or call toll-free 800-GLYTONE (459-8663)

  • Indications

    Apply generously 15 minutes before sun exposure

    etc

  • Keep out of reach of children.

    If swallowed, call a Poison Control Center right away.

  • Do not use

    On broken skin

  • Principal Display Panel - 50 mL Carton

    GLYTONE

    Hyda Lipid UV

    Mineral Sunscreen

    Broad spectrum SPF 40+

    Sun Protection

    Hyaluronic Acid

    Squalane

    Titanium Dioxide

    Zinc Oxide

    FRAGRANCE-FREE

    50 mL / 1.7 FL. OZ.

    Glytone Mineral Sunscreen

  • INGREDIENTS AND APPEARANCE
    GLYTONE HYDRA LIPID UV MINERAL SUNSCREEN  SPF 40 PLUS
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64760-720
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2 mg  in 50 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PEG-75 STEARATE (UNII: OT38R0N74H)  
    .BETA.-BISABOLOL (UNII: LP618AV2EA)  
    APPLE FRUIT OIL (UNII: 9NT987I3A8)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)  
    OAT KERNEL OIL (UNII: 3UVP41R77R)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    ALPHA-TOCOPHEROL, L- (UNII: 82190DH9F2)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    DICRATERIA ROTUNDA OIL (UNII: Z0DWU9R4GM)  
    SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)  
    DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)  
    DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)  
    TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)  
    POLYESTER-7 (UNII: 0841698D2F)  
    C12-15 ALKYL ETHYLHEXANOATE (UNII: GQJ580CH83)  
    LOCUST BEAN GUM (UNII: V4716MY704)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    SQUALANE (UNII: GW89575KF9)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    RUTTNERA LAMELLOSA OIL (UNII: 5XZ38R4SUT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64760-720-011 in 1 CARTON07/02/202003/31/2026
    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 DrugM02007/02/202003/31/2026
    Labeler - Pierre Fabre USA Inc. (117196928)
    Registrant - Pierre Fabre USA Inc. (117196928)
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