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| Product NDC Code | 61354-039 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Moisturizer |
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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 Avobenzone 3.0%, Octinoxate 7.29%, Octocrylene 3.0%, Oxybenzone 2.0%
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 For sunscree use: apply liberally 15 minutes sun exposure. Use a water resistant sunscreen if swimming or sweating. reapply at least every 2 hours. Sun protections measures. Spending time in the sun increases your risk of skin cancer and early skin again. To decrease this risk, regulary use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: lomit time in the sun, especially from 10 a.m - 2 p.m. wear long - sleeve shirts, pants, hats, and sunglasses. Children unther 6 months: ask a doctor.
Spl product data elements
Usually a list of ingredients in a drug product.Moisturizer Avobenzone GLYCERIN AVOBENZONE AVOBENZONE XANTHAN GUM OCTOCRYLENE OCTOCRYLENE WATER OXYBENZONE OXYBENZONE OCTINOXATE OCTINOXATE ISOHEXADECANE PHENOXYETHANOL SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW)
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.61354-039-01_AW
61354-039-02_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 damage 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 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 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.Uses Helps prevent sunburn If used as directed with other sun protections measures (see Directions), decreases the risk of skin cancer and early skin again caused by the sun
When using When using this product keep out of eyes. Rinse with water to remove.
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