Label: I KNOW VERY NECESSARY BROAD SPECTRUM SPF-40 MOISTURIZING CREAM- avobenzone, octisalate, octocrylene lotion

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

Drug Label Information

Updated November 11, 2023

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

  • Drug Facts

  • Active Ingredients

    Avobenzone 3.00 % Octisalate 5.00% Octocrylene 10.00 %

    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 skin aging caused by the sun
  • Warnings:

    not intended for ingestion 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

  • Other Information:

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

    1-888-985-2237

  • Directions:

    • Apply liberally 15 minutes before sun exposure
    • Children under 6 months of age: ask a doctor.
    • Reapply:
    • after 80 minutes of swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease therisk, 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.
  • Inactive Ingredients:

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Capric/Caprylic Triglyceride, Chamomilla Recutita (Chamomile) Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Macadamia Ternifolia Nut Oil, Mangifera Indica (Mango) Butter, Parfum (Fragrance),  Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate-20, Prunus Amygdalus Dulcis (Almond) Oil, Punica Granatum (Pomegranate) Extract, Retinyl Palmitate (Vitamin A), Rosa Canina (Rose) Hips Oil, Rosmarinus Officinalis (Rose) Hips Oil, Sesamum Indicum (Sesame) Oil, Squalane, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Vitis Vinifera (Grape) Seed Oil

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    I KNOW VERY NECESSARY BROAD SPECTRUM SPF-40 MOISTURIZING CREAM 
    avobenzone, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82188-222
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    TRICAPRILIN (UNII: 6P92858988)  
    CHAMOMILE (UNII: FGL3685T2X)  
    COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    MANGO (UNII: I629I3NR86)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALMOND (UNII: 3Z252A2K9G)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SESAME OIL UNSAPONIFIABLES (UNII: K9GA601CEG)  
    SQUALANE (UNII: GW89575KF9)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82188-222-001 in 1 CARTON09/01/2021
    150 mL in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/01/2021
    Labeler - Thirty7 LLC (107331862)