Label: RIO RADIANCE SPF 50 BODY OIL- octocrylene, homosalate, octisalate, avobenzone oil

  • NDC Code(s): 83982-4837-1
  • Packager: SOL DE JANEIRO USA, INC.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 27, 2024

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

  • ACTIVE INGREDIENT

    Drug Facts

    Active Ingredients Purpose

    Avobenzone (3.00%)....Sunscreen

    Homosalate (7.34%).....Sunscreen

    Octisalate (5.00%)........Sunscreen

    Octocrylene (10.00%)..Sunscreen

  • WARNINGS

    Warnings:

    • For extemal use only.
    • Do not use on damaged or broken skin.
    • When using this product keep our of eyes. Rinse
    with water to remove.
    • Stop use and ask a doctor if rash occurs.
    • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

    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 10am - 2pm.

    • Wear long-sleeved shirts, pants, hats, and sunglasses.

  • QUESTIONS

    Questions or comments?
    soldejaneiro.com

  • DOSAGE & ADMINISTRATION

    Dosage: Evenly and generously apply to skin.

    Administration: Topical

  • INACTIVE INGREDIENT

    Butyloctyl Salicylate, Carthamus Tinctorius Seed Oil, Diethylhexyl 2,6-Naphthalate, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Iron Oxides (CI 77491), Isododecane, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Oenocarpus Bataua Fruit Oil, Parfum (Fragrance), Phenoxyethanol, Pongamia Glabra Seed Oil, Pongamia Pinnata Seed Extract, Synthetic Fluorphlogopite, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Tocopheryl Acetate, Benzyl Salicylate, Citronellol, Limonene.

  • INDICATIONS & USAGE

    Uses:

    • Helps prevent sunburn.

    Directions:

    • Apply generously and evenly 15 minutes before sun exposure.
    • Children under 6 months of age: ask a doctor.
    • Reapply at least every 2 hours.
    • Use a water-resistant sunscreen if swimming or sweating.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • PURPOSE

    Sunscreen

  • PRINCIPAL DISPLAY PANEL

    Rio Radiance SPF 50 Body Oil_TubeRio Radiance SPF 50 Body Oil_Carton

  • INGREDIENTS AND APPEARANCE
    RIO RADIANCE SPF 50 BODY OIL 
    octocrylene, homosalate, octisalate, avobenzone oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83982-4837
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE77.4 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    ISODODECANE (UNII: A8289P68Y2)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    OENOCARPUS BATAUA FRUIT OIL (UNII: VU97MXB4Z2)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDE (UNII: YK3DC63Y5M)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    MICA (UNII: V8A1AW0880)  
    STANNOUS OXIDE (UNII: JB2MV9I3LS)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83982-4837-11 in 1 CARTON03/27/2024
    190 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/27/2024
    Labeler - SOL DE JANEIRO USA, INC. (080098027)