NDC 45334-332 Vanicream Sunscreen Broad Spectrum Spf 50

Zinc Oxide

NDC Product Code 45334-332

NDC 45334-332-03

Package Description: 1 TUBE in 1 CARTON > 85 g in 1 TUBE

NDC Product Information

Vanicream Sunscreen Broad Spectrum Spf 50 with NDC 45334-332 is a a human over the counter drug product labeled by Pharmaceutical Specialties, Inc.. The generic name of Vanicream Sunscreen Broad Spectrum Spf 50 is zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Pharmaceutical Specialties, Inc.

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.

Vanicream Sunscreen Broad Spectrum Spf 50 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.

  • ZINC OXIDE 12 g/100g

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.

  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • ISOPROPYL ISOSTEARATE (UNII: C67IXB9Y7T)
  • ALLANTOIN (UNII: 344S277G0Z)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • DIMETHICONOL/PROPYLSILSESQUIOXANE/SILICATE CROSSPOLYMER (450000000 MW) (UNII: 9KB5R958PB)
  • GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
  • GLYCERYL 1,3-DIBEHENATE (UNII: 84T2X52XS0)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • ISODECYL SALICYLATE (UNII: S7097PFP4C)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • WATER (UNII: 059QF0KO0R)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • POLYESTER-7 (UNII: 0841698D2F)
  • SQUALANE (UNII: GW89575KF9)
  • POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
  • TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • SILICA, TRIMETHYLSILYL CAPPED (UNII: VU10KU4B9S)
  • TRIBEHENIN (UNII: 8OC9U7TQZ0)

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.

Product Labeler Information

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

Labeler Name: Pharmaceutical Specialties, Inc.
Labeler Code: 45334
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: 04-05-2021 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: 12-31-2022 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 - NO 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Vanicream Sunscreen Broad Spectrum Spf 50 Product Label Images

Vanicream Sunscreen Broad Spectrum Spf 50 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

Other

Drug Facts

Vanicream is a trademark, or registered trademark of Pharmaceutical Specialties, Inc. in the U.S. or other countries.Dist. byPHARMACEUTICAL SPECIALTIES, INC.ROCHESTER, MN 55901 Made in USA

Otc - Active Ingredient

Active ingredientZinc oxide 12%

Otc - Purpose

PurposeSunscreen

Indications & Usage

  • Useshelps prevent sunburnif used as directed with other sun protection measures (see
  • Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WarningsFor external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - 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.

Dosage & Administration

  • Directionsapply liberally 15 minutes before sun exposurereapply:
  • After 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hourschildren under 6 months of age: Ask a doctorSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • Limit time in the sun, especially from 10 a.m. -2 p.m.wear long-sleeved shirts, pants, hats and sunglasses

Storage And Handling

Other information protect this product from excessive heat and direct sun

Inactive Ingredient

Inactive ingredients allantoin, butyloctyl salicylate, C12-15 alkyl benzoate. caprylyl glycol, dimethiconol/propylsilsesquioxane/silicate crosspolymer, glyceryl behenate, glyceryl dibehenate, glyceryl stearate, isodecyl salicylate, isopropyl isostearate, lecithin, neopentyl glycol diheptanoate, 1,2-hexanediol, polyester-7, polyglyceryl-3 polyricinoleate, propanediol, silica silylate, sodium chloride, squalane, tribehenin, tridecyl salicylate, water

Otc - Questions

Questions or Comments?800-325-8232www.vanicream.com

* Please review the disclaimer below.