Label: JESS BEAUTY SUN DROPS PROTECTION SPF 30- avobenzone, homosalate, octisalate, octocrylene oil

  • NDC Code(s): 83542-429-00
  • Packager: JESS BEAUTY PRODUCTS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 17, 2023

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  • Drug Facts

  • Active Ingredients

    Avobenzone 3%
    Homosalate 10%
    Octisalate 5%
    Octocrylene 10%

    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 skin aging caused by the sun.
  • Warnings

    For external use only.

    Do not use

    on damage or broken skin.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if

    if rash occours.

    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 two 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 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-sleeved shirts, pants, hats, and sunglasses.
  • Other Information

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

    Adansonia Digitata (Baobab) Oil, Aloe Extract, Bis-Vinyl Dimethicone/Dimethicone Copolymer, Butyloctyl Salicylate, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cyclopentasiloxane, Daucus Carota Sativa (Carrot) Extract, Dimethicone/Bis-isobutyl PPG-20 Crosspolymer, Isododecane, Squalane, Tocopherol (Vitamin E).

  • Package Lebeling:

    Label

  • INGREDIENTS AND APPEARANCE
    JESS BEAUTY SUN DROPS PROTECTION SPF 30 
    avobenzone, homosalate, octisalate, octocrylene oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83542-429
    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) HOMOSALATE100 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CARROT (UNII: L56Z1JK48B)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    ISODODECANE (UNII: A8289P68Y2)  
    SQUALANE (UNII: GW89575KF9)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83542-429-001 in 1 BOX11/01/2023
    130 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02011/01/2023
    Labeler - JESS BEAUTY PRODUCTS LLC (101816224)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pure Source, LLC080354456manufacture(83542-429)
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