NDC 0096-0688 Solbar Zinc Spf38

Solbar Zinc Spf38

NDC Product Information

Solbar Zinc Spf38 with NDC 0096-0688 is a a human over the counter drug product labeled by Person And Covey. The generic name of Solbar Zinc Spf38 is solbar zinc spf38. The product's dosage form is cream and is administered via topical form.

Labeler Name: Person And Covey

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

Product Type: Human Otc Drug 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.

Solbar Zinc Spf38 Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • HOMOSALATE .1015 1/g
  • OCTINOXATE .077 1/g
  • ZINC OXIDE .077 1/g

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.

  • WATER (UNII: 059QF0KO0R)
  • ISOBUTYL STEARATE (UNII: V8DPR6HNX3)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • EICOSYL POVIDONE (2 EICOSYL BRANCHES/REPEAT) (UNII: XQQ9MKE2BJ)
  • GLYCERYL DILAURATE (UNII: MFL3ZIE8SK)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • DIETHANOLAMINE CETYL PHOSPHATE (UNII: 4UG0316V9S)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • CYCLOMETHICONE (UNII: NMQ347994Z)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

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

Labeler Name: Person And Covey
Labeler Code: 0096
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 06-01-1996 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: 12-31-2021 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: N 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.

Solbar Zinc Spf38 Product Label Images

Solbar Zinc Spf38 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

Indications And Use

Helps prevent sunburn.

Purpose

Sunscreen

Keep Out Of The Reach Of Children

Yes. If swallowed, get medical help or contact a Poison Control Center right away.

Dosage And Administration

Apply liberally and evenly to all sun exposed areas of DRY skin 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating and immediately after towel drying. Apply at least every 2 hours. For children under 6 months, ask a physician.

Warnings

For external use only. Do not use on damaged or broken skin. Keep out of eyes. Rinse eyes thoroughly with water to remove. Stop use and ask a physician if rash or irritation develops and lasts. Store away from excessive heat and direct sun.

Otc - Active Ingredient Section

HomosalateOctinoxateZinc Oxide

Inactive Ingredient Section

WaterIsobutyl StearatePEG-100 StearateGlycerinDimethiconePVP/Eicosene CopolymerGlyceryl DilaurateCetyl AlcoholDEA Cetyl PhosphateBenzyl AlcoholCyclomethiconeStearyl AlcoholXanthan GumDisodium EDTACitric Acid

* Please review the disclaimer below.