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| Product NDC Code | 61354-033 | ||||
|---|---|---|---|---|---|
| Drug Name | Cream |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| 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 Zinc Oxide 20%
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 two hours Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures. Spending time in the sun increases you risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Board Spectrum SPF value 15 or higher and other sun protection measure including: Limit time in the sun, especially from 10am to 2 pm Wear long-sleeved shirt, pants, hats, and sunglasses Children under 6 months: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water/Aqua, Caprylic/Capric Triglyceride, Isoamyl Laurate, Coconut Alkanes, Glycerin, Polyglyceryl-3 Polyricinoleate, Silica, Glyceryl Caprylate, Lecithin, Rose (Rosa Damascena) Flower Extract, Algae, Aloe (Aloe Barbadensis) Leaf Juice, Isostearic Acid, Polyhydroxystearic Acid, Sunflower (Helianthus Annuus) Seed Oil, Sweet Iris (Iris Pallida) Leaf Cell Extract, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Coco-Caprylate/Caprate, Kukui (Aleurites Moluccanus) Seed Oil, Pumpkin (Cucurbita Pepo) Seed Oil, Squalane, Xanthan Gum, Tamanu (Calophyllum Inophylum) Seed Oil, Pomegranate (Punica Granatum) Extract, Chaparral (Larrea Tridentata) Extract, Leuconostoc/Radish Root Ferment Filtrate, Bisabolol, Tocopherol, Sodium Hyaluronate, Citric Acid
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 Zinc Oxide COCONUT ALKANES WATER MEDIUM-CHAIN TRIGLYCERIDES ISOAMYL LAURATE POLYHYDROXYSTEARIC ACID (2300 MW) SODIUM CHLORIDE SILICON DIOXIDE GLYCERYL CAPRYLATE ISOSTEARIC ACID ROSA X DAMASCENA FLOWER SUNFLOWER OIL POLYGLYCERYL-6 POLYRICINOLEATE LECITHIN, SOYBEAN POLYGLYCERYL-3 PENTARICINOLEATE GLYCERIN ZINC OXIDE ZINC OXIDE
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.Secondary package 27 ml 61354-033-01 61354-033-01_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 Do not use on damaged on 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 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 the product in this container from excessive heat and direct sun.
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 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.
User safety warnings
When a drug can pose a hazard to human health by contact, inhalation, ingestion, injection, or by any exposure, this field contains information which can prevent or decrease the possibility of harm.uses Help prevent sunburns if used as directed with other sun protection mesures (see Directions), decreases the risk of skin cancer and early aging caused by the 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