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| Product NDC Code | 61354-051 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Drug Name | Cream |
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| Type | Brand | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Dosage Form | LOTION | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Application Number | part352 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler Name | OXYGEN DEVELOPMENT, 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 Titanium Dioxide 4.55% Zinc Oxide 3.5%
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Cyclopentasiloxane, Isododecane, Mica, Polysilicone-11, Polymethylsilsesquioxane, Hexyl Laurate, PEG-10 Dimethicone, Polyglyceryl-4 Isostearate, Stearic Acid, Cetyl PEG/PPG-10/1 Dimethicone, Alumina, Triethoxycaprylylsilane, Dipalmitoyl Hydroxyproline, Diamond Powder, Iron Oxides.
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 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.Cream Titanium Dioxide, Zinc Oxide POLYMETHYLSILSESQUIOXANE (11 MICRONS) HEXYL LAURATE ISODODECANE MICA POLYGLYCERYL-4 ISOSTEARATE PEG-10 DIMETHICONE (600 CST) STEARIC ACID DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CYCLOMETHICONE 5 ZINC OXIDE ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE
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.Primary Package (Inner) 10 ML 61354-051-33 61354-051-06_AW
Secondary Package (Outer) 10 ml 61354-051-33 61354-051-33_AW
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 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 the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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 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 keep out of eyes. Rinse with water to remove.
Storage and handling
Information about safe storage and handling of the drug product.Directions Shake before use. Apply liberally 15 minutes before sun exposure. Use a water-resistant sunscreen of swimming or sweating. Reapply at least every 2 hours. Children under 6 months: Ask a doctor. Sun Protection Measures. Spending time in the sun increases our 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.- 2p.m. - Wear long-sleeved shirts, pants, hats and sunglasses.
Other information Protect the product in this container from excessive heat and direct sunlight. You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222.
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