Label: RIO RADIANCE SPF 50 BODYLOTION- zinc oxide lotion

  • NDC Code(s): 83982-4838-0
  • 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

    Zinc Oxide (20.00%)......Sunscreen

  • DOSAGE & ADMINISTRATION

    Dosage: Evenly and generously apply to skin.

    Administration: Topical

  • WARNINGS

    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.

    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.

  • INACTIVE INGREDIENT

    Aqua (Water, Eau), Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Carthamus Tinctorius Oleosomes, Cellulose Gum, Cetearyl Alcohol, Citric Acid, Coco-Glucoside, Cocos Nucifera (Coconut) Oil, Dicaprylyl Carbonate, Diisooctyl Succinate, Dimethicone, Ethylene/Propylene/Styrene Copolymer, Ethylhexyl Methoxycrylene, Ethylhexylglycerin, Euterpe Oleracea (Açaí) Fruit Oil, Gluconolactone, Glycerin, Hectorite, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Isononyl Isononanoate, Maleated Soybean Oil Glyceryl/Octyldodecanol Esters, Mica (CI 77019), Microcrystalline Cellulose, Niacinamide, Parfum (Fragrance), Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 20, Polysorbate 60, Pongamia Pinnata Seed Extract, Sodium Benzoate, Sodium Stearoyl Glutamate, Sorbitan Isostearate, Sorbitan Oleate, Tetrasodium Glutamate Diacetate, Theobroma Grandiflorum (Cupuaçu) Seed Butter, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Triethoxycaprylylsilane, 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 Lotion_CartonRio Radiance SPF 50 Body Lotion_Tube

  • INGREDIENTS AND APPEARANCE
    RIO RADIANCE SPF 50 BODYLOTION 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83982-4838
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    HECTORITE (UNII: 08X4KI73EZ)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    MICA (UNII: V8A1AW0880)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    ACAI OIL (UNII: Z0W6766A2W)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83982-4838-01 in 1 CARTON03/27/2024
    1240 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)