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| Product NDC Code | 66163-4838 | ||||
|---|---|---|---|---|---|
| Drug Name | Sol de janiero rio radiance spf 50 body |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Cosmetic Solutions LLC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide (20.00%)
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.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
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.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Sol de Janiero Rio Radiance SPF 50 Body Zinc Oxide Zinc Oxide ZINC OXIDE WATER BUTYLOCTYL SALICYLATE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL CARTHAMUS TINCTORIUS SEED OLEOSOMES CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CETOSTEARYL ALCOHOL CITRIC ACID MONOHYDRATE COCO GLUCOSIDE COCONUT OIL DICAPRYLYL CARBONATE DIMETHICONE ETHYLHEXYL METHOXYCRYLENE ETHYLHEXYLGLYCERIN ACAI OIL GLUCONOLACTONE GLYCERIN HECTORITE HYDROXYETHYL CELLULOSE, UNSPECIFIED FERRIC OXIDE RED FERROSOFERRIC OXIDE ISONONYL ISONONANOATE MICA MICROCRYSTALLINE CELLULOSE NIACINAMIDE PHENOXYETHANOL POLYSORBATE 20 POLYSORBATE 60 PONGAMIA PINNATA SEED SODIUM BENZOATE SODIUM STEAROYL GLUTAMATE SORBITAN ISOSTEARATE SORBITAN MONOOLEATE TETRASODIUM GLUTAMATE DIACETATE STANNIC OXIDE TITANIUM DIOXIDE TOCOPHEROL TRIETHOXYCAPRYLYLSILANE BENZYL SALICYLATE .BETA.-CITRONELLOL, (R)- LIMONENE, (+)-
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.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
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
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. If product is swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? soldejaneiro.com
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect this product from excessive heat and direct sun.
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.
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