NDC 72936-010 Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30

Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30

NDC Product Code 72936-010

NDC Code: 72936-010

Proprietary Name: Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30 What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30 What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

NDC Code Structure

  • 72936 - Higher Education Skincare, Llc
    • 72936-010 - Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30

NDC 72936-010-75

Package Description: 1 TUBE in 1 CARTON > 75 g in 1 TUBE

NDC Product Information

Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30 with NDC 72936-010 is a a human over the counter drug product labeled by Higher Education Skincare, Llc. The generic name of Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30 is higher education spring break oil-free broad-spectrum sunscreen spf 30. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Higher Education Skincare, Llc

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Higher Education Spring Break Oil-free Broad-spectrum Sunscreen 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.

  • OCTINOXATE 6.9 g/100g
  • OCTISALATE 3 g/100g
  • ZINC OXIDE 4 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.

  • WATER (UNII: 059QF0KO0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)
  • ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • CETEARETH-22 (UNII: 28VZG1E234)
  • CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • SQUALANE (UNII: GW89575KF9)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
  • ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
  • CUCUMIS SATIVUS LEAF (UNII: Q6S42514LP)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)
  • VITIS VINIFERA SEED (UNII: C34U15ICXA)
  • METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

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: Higher Education Skincare, Llc
Labeler Code: 72936
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: 03-09-2019 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

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: 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.

Higher Education Spring Break Oil-free Broad-spectrum Sunscreen Spf 30 Product Label Images

Higher Education Spring Break Oil-free Broad-spectrum 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

Active Ingredients

Octinoxate 6.9%Octisalate 3%Zinc Oxide 4%

Uses

• helps prevent sunburn • if 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

For external use only


Do not use on damaged or broken skin


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


Stop use and ask a docor if rash occurs


Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply generously 15 minutes before sun exposure


• reapply at least every 2 hours


• use a water-resistant sunscreen if swimming or sweating


• 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:


• limit time in the sun, especially from 10 a.m. - 2 p.m.


• wear long-sleeved shirts, pants, hats, and sunglasses


• children under 6 months of age: Ask a doctor

Inactive Ingredients

Aqua/Water/Eau, Glycerin, Caprylic/Capric Triglyceride, Isopropyl Palmitate, Propylene Glycol, Cyclopentasiloxane, Ceteareth-20, Cetearyl Alcohol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, VP/Eicosene Copolymer, Cyclotetrasiloxane, Squalane, Tocopheryl Acetate, Phenoxyethanol, Polysorbate 60, Triethoxycaprylylsilane, Chamomilla Recutita (Matricaria) Flower Extract, Citric Acid, Cucumis Sativus (Cucumber) Fruit Extract, Disodium EDTA, Sodium Hyaluronate, Propanediol, Camellia Oleifera Leaf Extract, Vitis Vinifera (Grape) Seed Extract, Methylisothiazolinone.

Other Information

• store at 20-25 C (68-77 F)

* Please review the disclaimer below.

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