NDC 71751-101 Kerstin Florian Multi-vitamin Day Creme Spf 30

Sunscreen

NDC Product Code 71751-101

NDC 71751-101-50

Package Description: 1 TUBE in 1 BOX > 50 g in 1 TUBE

NDC Product Information

Kerstin Florian Multi-vitamin Day Creme Spf 30 with NDC 71751-101 is a a human over the counter drug product labeled by Kerstin Florian, Inc.. The generic name of Kerstin Florian Multi-vitamin Day Creme Spf 30 is sunscreen. The product's dosage form is cream and is administered via topical form.

Labeler Name: Kerstin Florian, 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.

Kerstin Florian Multi-vitamin Day Creme Spf 30 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 20.2 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.

  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)
  • PANTHENOL (UNII: WV9CM0O67Z)
  • LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CUCUMIS SATIVUS WHOLE (UNII: 50560UL2YV)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SQUALANE (UNII: GW89575KF9)
  • RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)
  • CAMELLIA SINENSIS WHOLE (UNII: C5M4585ZBZ)
  • POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE (UNII: 9229XJ4V12)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • WATER (UNII: 059QF0KO0R)

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: Kerstin Florian, Inc.
Labeler Code: 71751
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: 10-10-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

End Marketing Date: 12-31-2024 What is the End Marketing Date?
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.

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.

Kerstin Florian Multi-vitamin Day Creme Spf 30 Product Label Images

Kerstin Florian Multi-vitamin Day Creme 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

Otc - Active Ingredient

Zinc Oxide 20.2%

Otc - Purpose

Sunscreen. Helps prevent sunburn. If used as directed with other sun protection measures (see directions), decreases risk of skin cancer and early skin aging by the sun.

Warnings

For external use only.

Otc - When Using

Do not use on damaged or broken skin.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 product is swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions:Apply liberally 15 minutes before sun exposure.Use a water-resistant sunscreen if swimming or sweating. Reapply atleast every 2 hours.Children under 6 months of age, ask a doctor

User Safety Warnings

Sun 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:Llimit time in the sun, especially from 10 a.m. - 2 p.m.Wear long-sleeved shirts, pants, hats, and sunglasses.

Other Safety Information

Protect the product in this container from excessive heat and direct sun

Inactive Ingredient

Water (Aqua), Coco-Caprylate, Dicaprylyl Carbonate, Ammonium Acryloyldimethyltaurate/ VP Copolymer, Propanediol, Polyhydroxystearic Acid, Glycerin, Cucumis Sativus (Cucumber) Fruit Extract, Tocopherol, Squalane, Rubus Idaeus (Raspberry) Leaf Extract, Sodium Ascorbyl Phosphate, Panthenol, Camellia Sinensis Leaf Extract, Polyglyceryl-2 Dipolyhydroxystearate, Tocopheryl Acetate, Ethylhexylglycerin, Citric Acid, Lauryl Glucoside, Phytic Acid, Xanthan Gum, Triethoxycaprylylsilane, Phenoxyethanol,Fragrance.

* Please review the disclaimer below.