Label: SUMMER GELEE SPF-4- homosalate, octisalate gel

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

Drug Label Information

Updated April 27, 2024

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  • Drug Facts

  • Active Ingredients

    Homosalate 2.00%, Octisalate 2.00%

    Purpose

    Sunscreen

  • Uses:

    Helps prevent sunburn.

    • Higher SPF gives more sunburn protection. 
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early 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 or irritation develops and lasts.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

    If pregnant or breast-feeding,

    ask a health professional before use.

  • Directions:

    Apply liberally 15 minutes before sun exposure and as needed.

    • Children under 6 months of age: ask a doctor.
    • 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 the 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-sleeved shirts, pants, hats, & sunglasses.
  • Other Information:

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

  • Inactive Ingredients:

    Cinnamomum Cassia Oil, Hydrogenated Vegetable Oil, Iron Oxides (CI 77492), Isopropyl Myristate, Mineral Oil, Ozokerite Wax, Paraffin, Parfum (Fragrance), Petrolatum, Tocopheryl Acetate (Vitamin E), D&C Red #17.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SUMMER GELEE SPF-4 
    homosalate, octisalate gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84281-476
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE20 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CHINESE CINNAMON OIL (UNII: A4WO0626T5)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    CERESIN (UNII: Q1LS2UJO3A)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    D&C RED NO. 17 (UNII: ND733RX3JN)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84281-476-0092.26 mL in 1 TUBE; Type 0: Not a Combination Product05/06/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/06/2024
    Labeler - SUMMER GELEE LLC (119209761)
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