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| Product NDC Code | 59958-201 | ||||
|---|---|---|---|---|---|
| Drug Name | Dermaroller anhydrous sunscreen spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | part352 | ||||
| Labeler Name | Owen Biosciences, Inc. | ||||
| 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.Drug Facts Active ingredients Purpose Titanium Dioxide 10.20% Sunscreen Zinc Oxide 3.70% Sunscreen
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Cyclopentasiloxane, Cyclomethicone, Dimethicone Crosspolymer, Methyl Methacrylate/Glycol Dimethacrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Melanin, Tribehenin, Calcium Behenate, Sorbitan Isostearate, Dimethiconol, Alumina, PEG-10 Dimethicone, Methicone, Iron Oxides.
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.Directions Apply evenly before sun exposure and as needed. For children under 6 months of age: ask a doctor. Reapply as needed or after towel drying, swimming or perspiring.
Purpose
Information about the drug product’s indications for use.USES Helps Prevent sunburn. Higher SPF gives more sunburn protection Provides moderate protection against sunburn.
Spl product data elements
Usually a list of ingredients in a drug product.Dermaroller Anhydrous Sunscreen SPF 30 Titanium Dioxide, Zinc Oxide CYCLOMETHICONE TRIBEHENIN FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE 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.image description
Dermaroller Anhydrous Sunscreen SPF 30: Information for patients
Information necessary for patients to use the drug safely and effectively, such as precautions concerning driving or the concomitant use of other substances that may have harmful additive effects.Other Information Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and other harmful effects of the 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 . When using this product keep out of eyes. Rinse with water to remove. Stop use and ask doctor if rash and irritation develops and lasts. Keep out of reach of children. If swallowed, get medical help or contact poison control 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