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Product NDC Code | 83982-4838 | ||||
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Drug Name | Rio radiance spf 50 bodylotion |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | SOL DE JANEIRO USA, INC. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active Ingredients Purpose Zinc Oxide (20.00%)......Sunscreen
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Dosage: Evenly and generously apply to skin. Administration: Topical
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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 and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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.
Purpose
Information about the drug product’s indications for use.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Rio Radiance SPF 50 BodyLotion Zinc Oxide TRIETHOXYCAPRYLYLSILANE NIACINAMIDE GLYCERIN COCO GLUCOSIDE PONGAMIA PINNATA SEED HECTORITE SAFFLOWER OIL TETRASODIUM GLUTAMATE DIACETATE ANHYDROUS CITRIC ACID ETHYLHEXYLGLYCERIN FERRIC OXIDE RED DICAPRYLYL CARBONATE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) DIMETHICONE ETHYLHEXYL METHOXYCRYLENE SORBITAN MONOOLEATE MEDIUM-CHAIN TRIGLYCERIDES ZINC OXIDE ZINC OXIDE POLYSORBATE 60 STANNIC OXIDE SODIUM STEAROYL GLUTAMATE COCONUT OIL CAPRYLYL GLYCOL SORBITAN ISOSTEARATE CETOSTEARYL ALCOHOL TITANIUM DIOXIDE MICA TOCOPHEROL THEOBROMA GRANDIFLORUM SEED BUTTER ISONONYL ISONONANOATE ACAI OIL HYDROXYETHYL CELLULOSE, UNSPECIFIED GLUCONOLACTONE SODIUM BENZOATE WATER BUTYLOCTYL SALICYLATE POLYSORBATE 20 PHENOXYETHANOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM POLYHYDROXYSTEARIC ACID (2300 MW) MICROCRYSTALLINE CELLULOSE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Rio Radiance SPF 50 Body Lotion_Carton Rio Radiance SPF 50 Body Lotion_Tube
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API