Label: SOL DE JANIERO RIO RADIANCE SPF 50 BODY- zinc oxide lotion

  • NDC Code(s): 66163-4838-1
  • 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 Ingredients

    Zinc Oxide (20.00%)

  • Purpose

    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

    • 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.

    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

    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 (Acai) Fruit Oil, Gluconolactone, Glycerin, Hectorite, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Hydroxyethylcellulose, Irons Oxides (CI77491), 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 (Cupuacu) Seed Butter, Tin Oxide (CI 77861), Titanium Dioxide (CI 77891), Tocopherol, Triethoxycaprylylsilane, Benzyl Salicylate, Citronellol, Limonene.

  • Questions or comments?

    soldejaneiro.com

  • PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton

    SOL
    DE
    JANEIRO

    SUN
    CARE

    RIO
    RADIANCE™
    SPF 50 • BODY LOTION

    Cheirosa 87 Fragrance

    100% MINERAL

    Illuminating Sunscreen

    UVA + UVB Broad Sprectrum SPF 50

    6.7 fl oz / 200 mL ℮

    PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    SOL DE JANIERO RIO RADIANCE SPF 50 BODY 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-4838
    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
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    ACAI OIL (UNII: Z0W6766A2W)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HECTORITE (UNII: 08X4KI73EZ)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    MICA (UNII: V8A1AW0880)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    PONGAMIA PINNATA SEED (UNII: C2BRV53B1V)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    TETRASODIUM GLUTAMATE DIACETATE (UNII: 5EHL50I4MY)  
    STANNIC OXIDE (UNII: KM7N50LOS6)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    BENZYL SALICYLATE (UNII: WAO5MNK9TU)  
    .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:66163-4838-11 in 1 CARTON03/27/2024
    1200 mL in 1 BOTTLE; 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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