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| Product NDC Code | 10967-690 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Rv illuminance serum tint broad spectrum 15 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | CREAM | ||||||
| Application Number | M020 | ||||||
| Labeler Name | REVLON CONSUMER PR Consumer Products Corp | ||||||
| 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 Active Ingredients Purpose Octinoxate 5.5% ...............Sunscreen Titanium dioxide 3.1%...... Sunscreen Zinc oxide (nano) 1.0 %.....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.Directions Directions Apply liberally 15 minutes before sun exposure. 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 10 a.m.–2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months of age: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Inactive Ingredients: Cyclohexasiloxane, Aqua/Water/Eau, Trimethylsiloxysilicate, Glycerin, Mica, PEG-10 Dimethicone, Dimethicone, Phenyl Trimethicone, PEG/PPG-18/18 Dimethicone, 1,2-Hexanediol, Alcohol Denat., Alumina, Caprylyl Glycol, Cyclopentasiloxane, Dimethiconol, Disteardimonium Hectorite, Ethylene Brassylate, Hexylene Glycol, Hydrogen Dimethicone, Lecithin, Magnesium Sulfate, Maris Sal/Sea Salt/Sel Marin, Methicone, Niacinamide, Polyquaternium-51, Polysilicone-11, Sodium Carrageenan, Sodium Hyaluronate, Sodium PCA, Tetrahexyldecyl Ascorbate, Tetrasodium EDTA, Tocopheryl Acetate, Trehalose, Triethoxycaprylylsilane, Triethyl Citrate, Urea, Zingiber Officinale (Ginger) Root Extract, Citral, Phenoxyethanol. MAY CONTAIN/PEUT CONTENIR/PUEDE CONTENER (+/-): [Bismuth Oxychloride (CI 77163), Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499), Titanium Dioxide (CI 77891).]. B03218
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 Uses Helps prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
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.RV Illuminance Serum Tint Broad Spectrum 15 Face foundation with SPF TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) GLYCERIN MICA OCTINOXATE OCTINOXATE CYCLOMETHICONE 6 DIMETHICONE CYCLOMETHICONE 5 EDETATE SODIUM .ALPHA.-TOCOPHEROL ACETATE TREHALOSE UREA 1,2-HEXANEDIOL ALUMINUM OXIDE DISTEARDIMONIUM HECTORITE LECITHIN, SOYBEAN GINGER CITRAL FERRIC OXIDE RED DIMETHICONOL (100000 CST) HEXYLENE GLYCOL HYALURONATE SODIUM TETRAHEXYLDECYL ASCORBATE FERRIC OXIDE YELLOW PHENOXYETHANOL WATER PEG/PPG-18/18 DIMETHICONE ALCOHOL PEG-10 DIMETHICONE (600 CST) CAPRYLYL GLYCOL ETHYLENE BRASSYLATE PHENYL TRIMETHICONE HYDROGEN DIMETHICONE (13 CST) SEA SALT POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) TRIETHYL CITRATE BISMUTH OXYCHLORIDE FERROSOFERRIC OXIDE MAGNESIUM SULFATE, UNSPECIFIED METHICONE (20 CST) NIACINAMIDE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CARRAGEENAN SODIUM PYRROLIDONE CARBOXYLATE TRIETHOXYCAPRYLYLSILANE
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.Carton Packaging Carton Packaging Carton Packaging
Tube Packaging Label Tube Packaging Label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.sections were updated to align with FDAs new section breakdown requirements
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Other information: Protect the product in this container from excessive heat and direct sun
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Questions? 1-800-473-8566 Monday - Thursday, 10AM - 12PM and 2PM - 4PM EST
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 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 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