Label: BRICKELL MENS PRODUCTS DAILY DEFENSE FACE MOISTURIZER SPF-20- octisalate, zinc oxide cream

  • 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

    Octisalate 5.00%

    Zinc Oxide 4.00

    Purpose

    Sunscreen

  • Uses:

    • Helps prevent sunburn. • 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.

  • Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Children under 6 months of age: Ask a doctor.
    • Reapply:
    • At least every two hours
    • Immediately after swimming, sweating or towel drying.
    • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with a broad Spectrum protection SPF of 15 or higher, along with other sun protection measures including: SUN PROTECTION MEASURES:
    • Limit time in the sun, especially from 10 a.m. – 2 p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses.
  • Other Information:

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

    Aloe Barbadensis Leaf (Aloe Vera Gel)Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Citrullus Lanatus(Watermelon) Extract, Decyl Glucoside, Dimethicone, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, C12-14Isoparaffin, Laureth-7, Phenoxyethanol, Polyacrylamide, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate.

  • Package Labeling:

    Label

  • INGREDIENTS AND APPEARANCE
    BRICKELL MENS PRODUCTS DAILY DEFENSE FACE MOISTURIZER SPF-20 
    octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82247-421
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    WATERMELON (UNII: 231473QB6R)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    C12-14 ISOPARAFFIN (UNII: WP37Z9V66A)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82247-421-00100 mL in 1 TUBE; Type 0: Not a Combination Product09/11/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02009/11/2023
    Labeler - BRICKELL BRANDS LLC (081141606)