NDC 72936-020 Higher Education Make Out Ready Moisturizing Lip Balm Spf 15

Higher Education Make Out Ready Moisturizing Lip Balm Spf 15

NDC Product Code 72936-020

NDC Code: 72936-020

Proprietary Name: Higher Education Make Out Ready Moisturizing Lip Balm Spf 15 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 Make Out Ready Moisturizing Lip Balm Spf 15 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.


Code Structure
  • 72936 - Higher Education Skincare, Llc
    • 72936-020 - Higher Education Make Out Ready Moisturizing Lip Balm Spf 15

NDC 72936-020-04

Package Description: 1 TUBE in 1 CARTON > 4 g in 1 TUBE

NDC Product Information

Higher Education Make Out Ready Moisturizing Lip Balm Spf 15 with NDC 72936-020 is a a human over the counter drug product labeled by Higher Education Skincare, Llc. The generic name of Higher Education Make Out Ready Moisturizing Lip Balm Spf 15 is higher education make out ready moisturizing lip balm spf 15. The product's dosage form is lipstick and is administered via topical form.

Labeler Name: Higher Education Skincare, Llc

Dosage Form: Lipstick - A waxy solid, usually colored cosmetic, in stick form for the lips.

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 Make Out Ready Moisturizing Lip Balm Spf 15 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 2 g/100g
  • OXYBENZONE 4.5 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.

  • HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)
  • SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
  • CASTOR OIL (UNII: D5340Y2I9G)
  • LANOLIN (UNII: 7EV65EAW6H)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • CORN OIL (UNII: 8470G57WFM)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • SUCRALOSE (UNII: 96K6UQ3ZD4)

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 Make Out Ready Moisturizing Lip Balm Spf 15 Product Label Images

Higher Education Make Out Ready Moisturizing Lip Balm Spf 15 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 2.0%Oxybenzone 4.5%

Uses

• helps prevent sunburn

Warnings

For external use only


Do not use on damaged or broken skin


Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early aging.


Stop use and ask a docor if rash or irritation develops and lasts


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

Directions

• apply liberally before sun exposure and as needed.


• children under 6 months of age: Ask a doctor

Inactive Ingredients

Helianthus Annuus (Sunflower) Seed Oil, Synthetic Beeswax, Ricinus Communis (Castor) Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, Aroma/Flavor, Sorbitan Oleate, Zea Mays (Corn) Oil, Tocopheryl Acetate, BHT, Sucralose

* Please review the disclaimer below.

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