Label: RODIAL BROAD SPECTRUM SPF 50 DROPS ANTI-BLUE LIGHT AND POLLUTION- octocrylene, octinoxate, oxybenzone, octisalate, avobenzone lotion

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

Drug Label Information

Updated November 10, 2023

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

  • Drug Facts

  • Active Ingredients

    Octocrylene 10% Octinoxate 7.5% Oxybenzone 6% Octisalate 5% Avobenzone 3%



    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 and evenly 15 minutes before sun exposure
    • children under 6 months of age: ask a doctor
    • 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
    • use a water-resistant sunscreen if swimming or sweating
    • reapply at least every 2 hours
  • Other information

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

    Water, Butylene Glycol, C12-15 Alkyl Benzoate, Glyceryl Stearate, Glycerin, PEG -100 Stearate, Octyldodecanol, Jojoba Esters, Glyceryl Stearate SE, Propanediol, Phenoxyethanol, Helianthus Annuus (Sunflower) Seed Wax, Saccharide Isomerate, Methyl Methacrylate Crosspolymer, Sodium Stearoyl Glutamate, Tocopheryl Acetate, Benzyl Alcohol, Bisabolol, Echium Plantagineum Seed Oil, Lecithin, Buddleja Officinalis Flower Extract, 1,2-Hexanediol, Carbomer, Disodium EDTA, Sodium Hyaluronate, Acacia Decurrens Flower Extract, Polyglycerin-3, Parfum (Fragrance), Helianthus Annuus (Sunflower) Seed Oil Unsaponifiables, Sodium Hydroxide, Biosaccharide Gum-4, Dehydroacetic Acid, Ethylbisiminomethylguaiacol Manganese Chloride, Cardiospermum Halicacabum Flower/Leaf/Vine Extract, Citric Acid, Sodium Citrate, Limonene, Alpha-isomethyl Ionone, Tocopherol, Citronellol.

  • Questions or comments?

    • Side effects occur. You may report side effects to FDA at 1-800-FDA-1088.
  • Package Labeling:

    BottleCarton

  • INGREDIENTS AND APPEARANCE
    RODIAL BROAD SPECTRUM SPF 50 DROPS ANTI-BLUE LIGHT AND POLLUTION 
    octocrylene, octinoxate, oxybenzone, octisalate, avobenzone lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52456-022
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE60 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SACCHARIDE ISOMERATE (UNII: W8K377W98I)  
    METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ACACIA DECURRENS FLOWER (UNII: 8PHF3LSM61)  
    POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    ETHYLBISIMINOMETHYLGUAIACOL MANGANESE CHLORIDE (UNII: SM5YJ88LTU)  
    CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    ISOMETHYL-.ALPHA.-IONONE (UNII: 9XP4LC555B)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    JOJOBA OIL (UNII: 724GKU717M)  
    BUDDLEJA OFFICINALIS FLOWER (UNII: 274707Y672)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52456-022-011 in 1 CARTON07/20/2021
    131 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02007/20/2021
    Labeler - Rodial Ltd. (237407262)