Label: ULTRA VIOLETTE VIBRANT SCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream

  • NDC Code(s): 84803-102-00
  • Packager: Grace and Fire USA Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 10, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENTS

    AVOBENZONE 3.0%
    HOMOSALATE 10%
    OCTISALATE 5.0%
    OCTOCRYLENE 8.0%

  • SUNSCREEN

  • USE

    HELPS PREVENT SUNBURN

    if used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin 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 occurs

    Keep out of reach of children

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

  • Directions

    Directions for Sunscreen Use

    apply liberally and evenly 15 minutes before sun exposure

    reapply at least every 2 hours

    use a water resistant sunscreen if swimming or sweating

    Sun Protection Measures. 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:

    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

  • Inactive Ingredients

    Water, Cera Alba, Cyclopentasiloxane, Cetearyl Alcohol, Isopropyl Palmitate, Ceteareth-20, Cyclohexasiloxane, Benzyl Alcohol, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Hydroxyacetophenone, Saccharide Isomerate, Mica, Phenoxyethanol, Triethanolamine, Sodium Stearoyl Glutamate, Carbomer, Fragrance, Citric Acid, Sodium Citrate, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491).

  • Other information

    Other information protect the product in this container from excessive heat and direct sun

  • Principal Display Panel

    UV VIBRANT SCREEN 100ML

  • INGREDIENTS AND APPEARANCE
    ULTRA VIOLETTE VIBRANT SCREEN BROAD SPECTRUM SPF 50 
    avobenzone, homosalate, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84803-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE80 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    CETEARETH-20 (UNII: YRC528SWUY)  
    WATER (UNII: 059QF0KO0R)  
    CYCLOPENTASILOXANE (UNII: 0THT5PCI0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    MICA (UNII: V8A1AW0880)  
    TRIETHANOLAMINE (UNII: 9O3K93S3TK)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    CARBOMER (UNII: 0A5MM307FC)  
    CI 77891 (UNII: 15FIX9V2JP)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CITRIC ACID (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CETEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CI 77491 (UNII: 1K09F3G675)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    HEXYL CINNAMAL (UNII: 7X6O37OK2I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84803-102-00100 mL in 1 BOTTLE; Type 0: Not a Combination Product12/15/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/01/2024
    Labeler - Grace and Fire USA Inc. (119357605)