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| Product NDC Code | 61354-035 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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% Homosalate 10% Octisalate 5% Octcrylene 1% Oxygenzone 5% Purpose: 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 For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every 2 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, butylene glycol, glyceryl stearate, cetearyl alcohol, glycerin, potassium cetyl phosphate, stearic acid, oligopeptide-24, polysorbate 60, polyester-8, sclerotium gum, bisabolol, phenoxyethanol, dimethicone, sodium PCA, squalana, tocopheryl acetate, helianthus annus (sunflower) seed oil, persea gratissima (avocado) oil, allantoin, caprylyl glycol, phytosterols, chlorphenesin, olea europaea (olive) fruit oil, disodium EDTA, glycolipids, sodium hyaluronate, citrus aurantium dulcis (orange) oil, zingiber officinale (ginger) root extract, tocopherol, citral, linalool, limonene
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, 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.MOISTURIZER AVOBENZONE, OXYBENZONE, OCTISALATE, HOMOSALATE, OCTOCRYLENE CETOSTEARYL ALCOHOL DIMETHICONE SQUALANE STEARIC ACID .ALPHA.-BISABOLOL, (+/-)- SUNFLOWER OIL HOMOSALATE HOMOSALATE POLYSORBATE 60 BETASIZOFIRAN PHENOXYETHANOL ALPHA-TOCOPHEROL ACETATE WATER OXYBENZONE OXYBENZONE OCTISALATE OCTISALATE POTASSIUM CETYL PHOSPHATE GLYCERIN POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) AVOBENZONE AVOBENZONE OCTOCRYLENE OCTOCRYLENE BUTYLENE GLYCOL GLYCERYL MONOSTEARATE
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 - primary 61354-030-04_AW
package label - secondary 61354-030-08_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 reach of children If 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.Sun Protection Measures Spending time in the sun increased your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF valuye of 15 or higher and other sun protection measures inclusing: limit time in the sun, specially from 10am - 2pm children under 6 months of age: ask a doctor
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 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.other information Protect the product in this container 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