NDC 59958-201 Dermaroller Anhydrous Sunscreen Spf 30

NDC Product Code 59958-201

NDC 59958-201-01

Package Description: 30 g in 1 TUBE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Dermaroller Anhydrous Sunscreen Spf 30 with NDC 59958-201 is a product labeled by Owen Biosciences, Inc.. The generic name of Dermaroller Anhydrous Sunscreen Spf 30 is . The product's dosage form is and is administered via form.

Labeler Name: Owen Biosciences, Inc.

Dosage Form: -

Product Type: What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Owen Biosciences, Inc.
Labeler Code: 59958
Start Marketing Date: 03-01-2011 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2020 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Dermaroller Anhydrous Sunscreen Spf 30 Product Label Images

Dermaroller Anhydrous Sunscreen Spf 30 Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Drug Facts

Active ingredients                  PurposeTitanium Dioxide 10.20%        SunscreenZinc Oxide 3.70%                  Sunscreen

Otc - Purpose

USESHelps Prevent sunburn.Higher SPF gives more sunburn protectionProvides moderate protection against sunburn.

Warnings

WarningsFor external use only. When using this productkeep out of eyes.  Rinse with water to remove.Stop use and ask doctor if rash and irritationdevelops and lasts.  Keep out of reach ofchildren. If swallowed, get medical help orcontact poison control center right away.

Indications & Usage

DirectionsApply evenly before sun exposure and as needed.  For children under 6 months of age: aska doctor.  Reapply as needed or after toweldrying, swimming or perspiring.

Information For Patients

Other InformationSun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risk of skin cancer, and otherharmful effects of the sun.

Inactive Ingredient

Inactive IngredientsCyclopentasiloxane, 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.

* Please review the disclaimer below.