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Cream - Medication Information

Product NDC Code 61354-089
Drug Name

Cream

Type Brand
Active Ingredients
Zinc oxide 24.05 mg/100mg
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name Oxygen Development LLC
Packages
Package NDC Code Description
61354-089-01 1 mg in 1 bottle, pump (61354-089-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredient Zinc Oxide 24%

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: after 80 minutes of swimming or sweating. Immediately after towel drying. 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 the risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am - 2 pm. Wear long-sleeved shirt, pants, hat, and sunglasses. Children under 6 months: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredient Water/Aqua, C15-19 Alkane, Glycerin, Polyglyceryl-3 Polyricinoleate, Ethyl Macadamiate, Caprylic/Capric Triglyceride, Styrene/Acrylates Copolymer, Stearyl/Octyldodecyl Citrate Crosspolymer, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Propanediol, Polyhydroxystearic Acid, Triethoxycaprylylsilane, 1,2-Hexanediol, Hydroxyacetophenone, Magnesium Sulfate, Sodium Chloride, Caprylhydroxamic Acid, Tocopheryl Acetate, Sodium Hyaluronate, Tocopherol, Malic Acid

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 Help prevent sunburn. If used as directed with other sun protection measures (see Directions), decreases the risk of cancer and early skin 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 Zinc Oxide 1,2-HEXANEDIOL HYDROXYACETOPHENONE MAGNESIUM SULFATE, UNSPECIFIED WATER STYRENE PROPANEDIOL SODIUM CHLORIDE STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER MEDIUM-CHAIN TRIGLYCERIDES LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE POLYHYDROXYSTEARIC ACID (2300 MW) TRIETHOXYCAPRYLYLSILANE ETHYL MACADAMIATE C15-19 ALKANE 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.
Package label 61354-089-01_aw

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 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. May stain some fabrics. You may report a serious adverse event to the phone number provided below.

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 When using this product keep out of the 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. Do not use on damaged or broken skin.

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