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Moisturizer - Medication Information

Product NDC Code 61354-032
Drug Name

Moisturizer

Type Brand
Active Ingredients
Avobenzone 3 mg/100mg
Octinoxate 7.49 mg/100mg
Route TOPICAL
Dosage Form CREAM
Application Number part352
Labeler Name OXYGEN DEVELOPMENT, LLC
Packages
Package NDC Code Description
61354-032-01 1 bottle in 1 carton (61354-032-01) / 60 mg in 1 bottle
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Avobenzone 3.0%, Octinoxate 7.5%.

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 suncreen use: 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. - 2p.m. Wear long-sleeved shirts, pants, hats and sunglasses Children under 6 months of age: Ask a doctor.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredients Water, diisopropyl sebacate, butylene gycol, cyclopentasiloxane, glyceryl stearate, stearic acid, cetyl phosphate, cetearyl alcohol, sh-oligopeptide-1, phenoxyethanol, sodium PCA, polysorbate 60, aminomethyl propanol, citrus aurantium dulcis (orange) fruit extract, allantoin, methylparaben, carbomer, bisabolol, propylparaben, tocopheryl acetate, disodium EDTA, laminaria saccharina extract, glycolipids, sodium hyaluronate.

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.
MOISTURIZER AVOBENZONE, OCTINOXATE DIISOPROPYL SEBACATE BUTYLENE GLYCOL CYCLOMETHICONE 5 GLYCERYL MONOSTEARATE STEARIC ACID CETYL PHOSPHATE CETOSTEARYL ALCOHOL PHENOXYETHANOL OCTINOXATE OCTINOXATE AVOBENZONE AVOBENZONE WATER

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 60 ml 61354-032-01 61354-032-01_AW Secondary package 60ml, 61354-032-01 61354-032-01_AW 61354-032-01_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 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 Posion Contorl 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 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 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. Do Not Use Do Not Use on damaged or broken skin. When using this product When using this product keep out of eyes. Rinse with water to remove. Stop use Stop use and ask a doctor if rash occurs. Keep out of reach of children Keep out of reach of children. If swallowed, get medical help or contact a Posion Contorl Center right away.

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