Label: SEA CLEARLY HYDRATING FACIAL SPF 35 KINETIN- octocrylene, octisalate,homosalat, avobenzone cream

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

Drug Label Information

Updated December 5, 2023

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

  • ACTIVE INGREDIENT

    Active ingredient,

    Octocrylene – 10 %

    Octisalate – 5%

    Homosalate – 5%

    Avobenzone – 2.5 %

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses. Helps prevent sunburn.

    If used as directed with other sun protection measures (see Direction), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    Warnings

    For external use only.

  • DO NOT USE

    Do not use on damaged or broken skin.

  • WHEN USING

    When using this product keep out of eye.Rinse with water to remove.

  • STOP USE

    Stop use and ask doctor if skin rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children, If product is swallowed, get medical help or contact a poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions.

    Apply generously and evenly 15 minutes before sun exposure.

    Reapply: after 40 minutes of swimming or sweating.

    Immediately after towel drying. At least every 2 hours.

    Sun Protection Measures: Spending time the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use of sunscreen with a broad spectrum SPF value 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. Children under 6 months of age: Ask a doctor.

  • OTHER SAFETY INFORMATION

    Other information.

    Protect this product from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Inactive ingredient:

    Isododecane, Polymethylsilsesquioxane, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Butyloctyl Salicylate, Dimethicone Crosspolymer, Dimethicone,Camellia Oleifera (Seed) Oil,Prunus Armeniaca (Apricot) Kernel Oil, Carthamus Tinctorius ( Safflower) Seed Oil, Aloe Barbandensis Leaf Extract, Kinetin, Squalane,Tocopherol, Tocopheryl Acetate.

  • PRINCIPAL DISPLAY PANEL

    Sea Clearly Hydrating Facial SPF 35

  • INGREDIENTS AND APPEARANCE
    SEA CLEARLY HYDRATING FACIAL SPF 35 KINETIN 
    octocrylene, octisalate,homosalat, avobenzone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4237
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 g
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 g
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
    POLYMETHYLSILSESQUIOXANE/TRIMETHYLSILOXYSILICATE (UNII: X2PZH4Y6HT)  
    KINETIN (UNII: P39Y9652YJ)  
    DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    ISODODECANE (UNII: A8289P68Y2)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4237-150 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/05/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/05/2023
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4237)