Label: EB-5 SUPER HYDRATING ANTI-AGING SPF-50- octocrylene, zinc oxide, octisalate cream

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

Drug Label Information

Updated June 17, 2024

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

  • Drug Facts

  • Active Ingredients

    Octocrylene 10.00%

    Zinc Oxide 8.00%

    Octisalate 5.00%  

    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 all over the face, neck and chest 15 minutes before sun exposure. To maintain original protection, reapply every 2 hours. Use every morning as the last step in your daily skincare regime. Can be used alone or under make-up. Can also be used on full body.
    • Children under 6 months of age: ask a doctor.
    • Use a water -resistant sunscreen if swimming or sweating

    Sun Protection Measures

    Sp ending 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.
  • Other Ingredients:

    Acetyl Hexapeptide-8, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Ascorbic Acid (Vitamin C), Butylene Glycol, Butyrispermum Parkii (Shea) Butter, C13-16 Isoalkane, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglycerin, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Chamomilla Matricaria (Chamomile) Extract, Citric Acid, Coco Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Dodecane, Ethylhexlyglycerin, Ethyl Vanillin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunfloer) Oil, Heptyl Undecylenate, Hyaluronic Acid, Magnesium Aluminum Silicate, Palmitoyl Tetrapeptide-7, Palmitoyl Tripeptide-1, Persea Gratissima (Avocado) Oil, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, Sodium citrate, Sorbitan Stearate, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Xanthan Gum, Zemea (Corn) Propanediol.

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    EB-5 SUPER HYDRATING ANTI-AGING SPF-50 
    octocrylene, zinc oxide, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84060-439
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION80 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETYL HEXAPEPTIDE-8 AMIDE (UNII: L4EL31FWIL)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    C13-16 ISOPARAFFIN (UNII: LED42LZG6O)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCONUT (UNII: 3RT3536DHY)  
    CARROT (UNII: L56Z1JK48B)  
    DODECANE (UNII: 11A386X1QH)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HEPTYL UNDECYLENATE (UNII: W77QUB6GXO)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    PALMITOYL TRIPEPTIDE-1 (UNII: RV743D216M)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84060-439-001 in 1 BOX12/26/2023
    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 DrugM02012/26/2023
    Labeler - LIFE O, INC. (118732367)