Label: SOLAR SENSE SPF 50 DAILY FACIAL SUNSCREEN- homosalate, octocrylene, octisalate, avobenzone cream

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

Drug Label Information

Updated November 5, 2023

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

  • Drug Facts

  • Active Ingredients

    Homosalate 10.0%

    Octocrylene 10.0%

    Octisalate 5.0%

    Avobenzone 3.0%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn

    • If used as directed with other sun protection measure (see directions), decreases the risk of skin cancer and early skin aging caused by the sun

    • Higher SPF gives more sunburn protection.

  • 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 consult physician if

    • irritation or rash developes and lasts.

    Keep out of reach of children.

    If product is swallowed, get medical attention or contact poison control center immediately.

  • Directions

    • Apply liberally 15-minutes before sun exposure

    At least every two-hours immediately after swimming, sweating or towel drying   REAPPLY:

    •Children under 6 months of age: ask a doctor.

    Spending time in the sun increases your risk of skin cancer and  early skin aging. To decrease this risk, SUN PROTECTION MEASURES:

    regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:

    • Limit time in the sun, especially between 10am - 2pm

    • Wear long sleeve shirts, pants, hats and sunglasses.

  • Inactive Ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Cetearyl Alcohol, Cetearyl Olivate, Cocamidopropyl Betaine, Cucumis Sativus (Cucumber) Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, C13-14 Isoparaffin, Isopropyl Myristate, Laureth-7, Parfum (Fragrance), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

  • Other information

    Protect this product from excessive heat and direct sunlight.

  • Questions?

    Call 1-800-595-6230 or visit www.solarsensespf.com

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    SOLAR SENSE SPF 50 DAILY FACIAL SUNSCREEN 
    homosalate, octocrylene, octisalate, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61543-0154
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    CUCUMBER SEED (UNII: BT3S9L53JK)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61543-0154-11 in 1 CARTON07/08/2020
    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 DrugM02007/08/2020
    Labeler - CCA Industries, Inc (106771041)