Label: SOL DE JANIERO RIO RADIANCE SPF 50 BODY- avobenzone, homosalate, octisalate, and octocrylene oil

  • NDC Code(s): 66163-4837-1
  • Packager: Cosmetic Solutions LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 18, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active IngredientsPurpose
    Avobenzone(3.00%)Sunscreen
    Homosalate(7.34%)Sunscreen
    Octisalate(5.00%)Sunscreen
    Octocrylene(10.00%)Sunscreen
  • Uses

    • Helps prevent sunburn.
  • 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 product is swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • Shake well before use.
    • 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.
  • SPL UNCLASSIFIED SECTION

    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.
  • Other Information

    Protect this product from excessive heat and direct sun.

  • Inactive Ingredients

    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.

  • Questions or comments?

    soldejaneiro.com

  • PRINCIPAL DISPLAY PANEL - 90 mL Cylinder Carton

    SOL
    DE
    JANEIRO

    SUN CARE

    RIO
    RADIANCE™

    SPF 50 • BODY OIL

    Cheirosa 87 Fragrance

    Shimmering
    Sunscreen

    UVA + UVB

    Broad Spectrum SPF 50

    3 fl oz / 90 mL ℮

    PRINCIPAL DISPLAY PANEL - 90 mL Cylinder Carton
  • INGREDIENTS AND APPEARANCE
    SOL DE JANIERO RIO RADIANCE SPF 50 BODY 
    avobenzone, homosalate, octisalate, and octocrylene oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-4837
    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) Homosalate77.4 mg  in 1 mL
    Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate50 mg  in 1 mL
    Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene100 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    ISODODECANE (UNII: A8289P68Y2)  
    MICA (UNII: V8A1AW0880)  
    OENOCARPUS BATAUA FRUIT OIL (UNII: VU97MXB4Z2)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    KARUM SEED OIL (UNII: 62160PU6FJ)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-4837-11 in 1 CARTON03/27/2024
    190 mL in 1 CYLINDER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM02003/27/2024
    Labeler - Cosmetic Solutions LLC (807907928)
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