Label: CHUDA- avobenzone, homosalate, octinoxate, octisalate cream

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

Drug Label Information

Updated October 28, 2023

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

  • Drug Facts

  • Active ingredients

    Avobenzone 3% Homosalate 15% Octinoxate 7.5%

    Octisalate 5%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
  • 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 occurs

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Sun Protection Measures.
    • 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 information

    Protect the product in this container from excessive heat and direct sun

  • Inactive ingredients?

    Water, Cyclopentasiloxane, Polymethylsilsesquioxane, Polysilicone-15, Cetyl PEG/PPG-10/1 Dimethicone, Trimethylsiloxysilicate, Tribehenin, Olive (Olea europaea) Fruit Oil, Damask Rose (Rosa damascena) Flower Oil, Calcium Carbonate, Beeswax, Pollen, Propolis, Silica, Tocopheryl Acetate, Phenoxyethanol, Dimethicone/Vinyl Dimethicone Crosspolymer, Sodium Dehydroacetate, Dimethicone, Sodium Hyaluronate, Panthenol, Dimethiconol, Tetrasodium EDTA, Aminomethyl Propanol, Allantoin, Magnesium Aluminum Silicate, Sodium Ascorbate

  • Package Labeling:

    Outer PackageInner Package

  • INGREDIENTS AND APPEARANCE
    CHUDA 
    avobenzone, homosalate, octinoxate, octisalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71784-000
    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) HOMOSALATE150 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    POLYSILICONE-15 (UNII: F8DRP5BB29)  
    TRIBEHENIN (UNII: 8OC9U7TQZ0)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    ROSA X DAMASCENA FLOWERING TOP (UNII: 21W82Q764G)  
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    POLLEN (UNII: 3729L8MA2C)  
    PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALLANTOIN (UNII: 344S277G0Z)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    SODIUM ASCORBATE (UNII: S033EH8359)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71784-000-001 in 1 CARTON01/01/2015
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/01/2015
    Labeler - Premier Ocher LLC (046604850)