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Product NDC Code | 77358-201 | ||||
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Drug Name | Bluevado sunfix |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | Magic Blue, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide 8.2% Titanium Dioxide 2.8%
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: after 40 minutes of swimming or sweating; immediately after towel drying; at least every 2 hours • 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 of 15 or higher and other sun protection measures including: o Limit time in the sun, especially from 10 a.m. – 2 p.m. o Wear long sleeves shirts, pants, hats, and sunglasses o Children under 6 months: Ask a physician.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients: Argania Spinosa (Argan) Kernel Oil, Ascorbyl Palmitate, Bisabolol Butyrospermum Parkii (Shea) Butter, C13-15 Alkane, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Cetearyl Alcohol, Cetyl Alcohol, Citrus Aurantium Bergamia (Bergamot) Peel Oil, Citrus Grandis (Grapefruit) Peel Oil, Cocos Nucifera (Coconut) Oil, Glycerin, Glyceryl Stearate, Heptyl Undecylenate, Jojoba Esters, Lavandula Angustifolia (Lavender) Oil, Methylene Blue, Oryza Sativa (Rice) Bran Oil, PEG-100 Stearate, Pelargonium Graveolens (Geranium) Leaf Oil, Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate 60, Sorbitan Laurate, Tocopheryl Acetate, Water (Aqua), Xanthan Gum.
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 used with other sun protection measures (see Directions) decreases the risk of skin cancer and early skin aging.
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.Bluevado Sunfix Zinc Oxide, Titanium Dioxide ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ARGAN OIL ASCORBYL PALMITATE LEVOMENOL SHEA BUTTER C13-15 ALKANE MEDIUM-CHAIN TRIGLYCERIDES CETOSTEARYL ALCOHOL CETYL ALCOHOL BERGAMOT OIL CITRUS MAXIMA FRUIT RIND OIL COCONUT OIL GLYCERIN GLYCERYL MONOSTEARATE HEPTYL UNDECYLENATE LAVENDER OIL METHYLENE BLUE RICE BRAN OIL PEG-100 STEARATE GERANIUM OIL, ALGERIAN TYPE PHENOXYETHANOL POLYSORBATE 60 SORBITAN MONOLAURATE .ALPHA.-TOCOPHEROL ACETATE WATER XANTHAN GUM
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 Bluelene® Bluevado™ SunFix Protects, Repairs & Moisturizes SPF 21 SPF DAY CREAM Revolutionary Anti-aging Technology Mineral + Methylene Blue Broad-Spectrum UVA/UVB Coverage CORAL SAFE 3 fl oz (90 mL) Manufactured for Mblue Labs, Bethesda, MD 20817, USA 1-800-988-8068 www.bluelene.com Label image-01
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: Protect this product from excessive heat and direct sun. Provides moderate protection against sunburn.
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 thus product keep out of eyes. Rinse with water to remove. • Stop use and ask a physician 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