NDC 66738-302 Jack Black Lavender Lip Balm 0.25oz

Lip Balm Sunscreen

NDC Product Code 66738-302

NDC 66738-302-25

Package Description: 7 g in 1 TUBE

NDC Product Information

Jack Black Lavender Lip Balm 0.25oz with NDC 66738-302 is a a human over the counter drug product labeled by Jack Black, L.l.c.. The generic name of Jack Black Lavender Lip Balm 0.25oz is lip balm sunscreen. The product's dosage form is ointment and is administered via topical form.

Labeler Name: Jack Black, L.l.c.

Dosage Form: Ointment - A semisolid3 dosage form, usually containing <20% water and volatiles5 and >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.

Jack Black Lavender Lip Balm 0.25oz 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.

  • AVOBENZONE 30 g/1000g
  • OCTINOXATE 75 g/1000g
  • PETROLATUM 402 g/1000g

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.


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: Jack Black, L.l.c.
Labeler Code: 66738
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 03-03-2021 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.

Jack Black Lavender Lip Balm 0.25oz Product Label Images

Jack Black Lavender Lip Balm 0.25oz 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

Avobenzone 3.0% SunscreenOctinoxate 7.5% SunscreenPetrolatum 40.2% Skin Protectant


Helps prevent sunburn and chapped lips.


Stop use if skin rash occurs.


Apply liberally and reapply every 2 hours or after eating, drinking, swimming or wiping lips. Children under 6 months of age: Ask a doctor.

Inactive Ingredients

Beeswax, Butyrospermum parkii (Shea) Butter, C 18-38 Alkyl Hydroxystearoyl Stearate, Camellia Sinensis (Green tea) Leaf Extract, Cyclohexasiloxane, Cyclopentasiloxane, Flavor, Lanolin, Microcyrstalline Wax, Ozokerite, Persea gratissima (avocado) oil, Polyglyceryl-3 Beeswax, Theobroma cacao (cocoa) See Butter, Tocopheryl Acetate


Made in USA for Jack Black, LLCCarrollton, TX 750061-877-766-3388 www.getjackblack.com

* Please review the disclaimer below.