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| Product NDC Code | 61197-300 | ||||
|---|---|---|---|---|---|
| Drug Name | Ultra cc radiant foundation broad spectrum spf 17 cool-deep |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Pacifica Beauty, 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 Purpose Zinc Oxide 11.4% 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 Apply liberally 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply 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 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-sleeve shirts, pants, hats and sunglasses. Children under 6 months : Ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Sorbitan Sesquioleate, Dimethicone, Potassium Cetyl Phosphate, Glycerin, Silica, Jojoba Esters, Cetearyl Olivate, Sorbitan Olivate, Mica, Citric Acid, Potassium Sorbate, Sodium Dehydroacetate, Sodium Benzoate, Fragrance (All Natural), Sodium Hyaluronate, Cocos Nucifera (Coconut) Water, Withania Somnifera Root Extract, Carthamus Tinctorius (Saffower) Seed Oil, Macrocystis Pyrifera Extract, Linalool, Amyl Cinnamal, Titanium Dioxide CI 77891, Iron Oxides CI 77491, CI 77492, and CI 77499.
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.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.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.
Spl product data elements
Usually a list of ingredients in a drug product.Ultra CC Radiant Foundation Broad Spectrum SPF 17 Cool-Deep Zinc Oxide POTASSIUM SORBATE SAFFLOWER OIL MACROCYSTIS PYRIFERA ZINC OXIDE ZINC OXIDE SORBITAN SESQUIOLEATE HYDROLYZED JOJOBA ESTERS (ACID FORM) SORBITAN OLIVATE MICA SODIUM DEHYDROACETATE SODIUM BENZOATE HYALURONATE SODIUM SILICON DIOXIDE CETEARYL OLIVATE CITRIC ACID MONOHYDRATE COCONUT WATER WITHANIA SOMNIFERA ROOT GLYCERIN WATER MEDIUM-CHAIN TRIGLYCERIDES .ALPHA.-AMYLCINNAMALDEHYDE TITANIUM DIOXIDE DIMETHICONE POTASSIUM CETYL PHOSPHATE FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE LINALOOL, (+/-)- FERRIC OXIDE RED
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.Ultra CC Radiant Foundation Broad Spectrum SPF 17 Cool-Deep Label Ultra CC Radiant Foundation Broad Spectrum SPF 17 Cool-Deep Label
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use Do not use on damaged or broken skin.
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 Keep out of reach of children. If 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? Call toll free 1-888-322-2466 (8am to 5pm Pacific time, Monday-Friday)
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.STOP USE AND ASK A DOCTOR STOP USE AND ASK A DOCTOR IF RASH OCCURS.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product When using this product keep out of eyes. Rinse with water to remove.
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.
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