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| Product NDC Code | 58274-008 | ||||
|---|---|---|---|---|---|
| Drug Name | Brush on block nude tint protective lip oil broad spectrum spf 32 |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | part352 | ||||
| Labeler Name | SPF Ventures, 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 Ingredient Titanium Dioxide 4.5% Zinc Oxide 3.4%
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 liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating Children under 6 months: Ask a doctor Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirt, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Alumina, Argania Spinosa Kernel Oil, Bisabolol, Butylene/Ethylene/Styrene Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citrus Reticulata (Tangerine) Peel Oil, Ethylene/Propylene/Styrene Copolymer, Flavor, Helianthus Annuus (Sunflower) Seed Oil, Hydrogenated Polyisobutene, Iron Oxides, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Polyhydroxystearic Acid, Ricinus Communis (Castor) Seed Oil, Stearic Acid, Tocopheryl Acetate
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 If issued 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.Brush on Block Nude Tint Protective Lip Oil Broad Spectrum SPF 32 TITANIUM DIOXIDE, ZINC OXIDE ALUMINUM OXIDE ARGAN OIL LEVOMENOL BUTYLOCTYL SALICYLATE MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL GLYCOL MANDARIN OIL SUNFLOWER OIL HYDROGENATED POLYBUTENE (1300 MW) FERRIC OXIDE RED PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) POLYHYDROXYSTEARIC ACID (2300 MW) CASTOR OIL STEARIC ACID ALPHA-TOCOPHEROL ACETATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC CATION
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.Package Label - Principal Display Panel Carton Label Inner label Carton label Inner label
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 swallowed, get medical help or contact a Poison Control Center right away.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product from excessive heat and direct sun Questions or Comments? Call toll free 1-800-916-7690
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.
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