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Powder - Medication Information

Product NDC Code 61354-118
Drug Name

Powder

Type Brand
Active Ingredients
Ferric oxide red 1.75 mg/100mg
Titanium dioxide 10 mg/100mg
Route TOPICAL
Dosage Form POWDER
Application Number M020
Labeler Name Oxygen Development LLC
Packages
Package NDC Code Description
61354-118-02 1 cup in 1 carton (61354-118-02) / 100 mg in 1 cup (61354-118-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Titanium Dioxide

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 • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient Mica, Caprylic/Capric Triglyceride, Boron Nitride, Bismuth Oxychloride, Zinc Stearate, Magnesium Silicate, Sodium Starch Octenylsuccinate, Mannitol, Sodium Gluconate, Citric Acid, Sodium Citrate, Waltheria Indica Leaf Extract, Dextrin, Ferulic Acid, Lactic Acid (L), Butyrospermum Parkii (Shea) Butter, Retinol, Ceramide AP, Silica, Tocopheryl Acetate, Aqua, Glucosamine HCI, Pisum Sativum (Pea) Extract, Bambusa Vulgaris Leaf/Stem Extract, Magnesium Carbonate, Iron Oxides (CI 77491, CI 77492, CI 77499), May Contain: Titanium Dioxide (CI 77891), Ultramarines (CI 77007).

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.

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.
Powder Titanium Dioxide MEDIUM-CHAIN TRIGLYCERIDES MAGNESIUM SILICATE MANNITOL BORON NITRIDE SILICON DIOXIDE SODIUM STARCH GLYCOLATE TYPE A MICA BISMUTH OXYCHLORIDE ZINC STEARATE FERRIC OXIDE RED FERRIC OXIDE RED TITANIUM DIOXIDE TITANIUM DIOXIDE

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 - Principal display panel 61354-118-01-aw 61354-118-02_aw 61354-118-01_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 poison control center right away.

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 eyes. Rinse with water to remove

Storage and handling

Information about safe storage and handling of the drug product.
Other Information Protect this product from excessive heat and direct sun • In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.

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