NDC 66738-304 Jack Black Sun Guard Sunscreen Spf45

Sunscreen

NDC Product Code 66738-304

NDC 66738-304-14

Package Description: 113 g in 1 TUBE

NDC 66738-304-27

Package Description: 44 g in 1 TUBE

NDC Product Information

Jack Black Sun Guard Sunscreen Spf45 with NDC 66738-304 is a a human over the counter drug product labeled by Jack Black, Llc. The generic name of Jack Black Sun Guard Sunscreen Spf45 is sunscreen. The product's dosage form is lotion and is administered via topical form.

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.

Jack Black Sun Guard Sunscreen Spf45 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.


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.

  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
  • WATER (UNII: 059QF0KO0R)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
  • LEONTOPODIUM ALPINUM FLOWER (UNII: MWN6IZU3XM)
  • PEUCEDANUM OSTRUTHIUM LEAF (UNII: 86P27YRR6Y)
  • BUDDLEJA DAVIDII LEAF (UNII: X380815D32)
  • ARTEMISIA UMBELLIFORMIS FLOWER (UNII: 91OLL9AJ7D)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • ETHYLHEXYL ISONONANOATE (UNII: I6KB4GE3K4)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • GLYCERIN (UNII: PDC6A3C0OX)

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, Llc
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: 02-09-2010 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: 12-31-2021 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 Sun Guard Sunscreen Spf45 Product Label Images

Jack Black Sun Guard Sunscreen Spf45 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

Octisalate   3.0%   SunscreenOctinoxate   7.5%   SunscreenZinc Oxide   8.0%   Sunscreen

Uses

Helps prevent sunburn

Warnings

  • For external use onlyDo not use on damaged or broken skinStop use and ask doctor if rash occursWhen using this product keep out of eyesRinse with water to removeKeep out of reach of childrenIf swallowed, get medical help or contact Poison Control Cneter right away

Directions

  • Apply liberally 15 minutes before sun exposureReapply: after 80 minutes of swimming or sweatingImmediately after towel dryingAt least every two hoursChildren under 6 months: ask a doctorSpending time in the sun increases your risk of skin cancer and early skin aging.To decrease this risk, regularly use sunscreen with a broad spectrum SFP value of 15 or higherLimit time in the sun, eespecially from 10 a.m. - 2 p.m.

Inactive Ingredients

Artemisia Umbelliformis Extract, Ascorbyl Palmitate, Buddleja Davidii Leaf Extract, Butylene Glycol, Calendula Officinalis Flower Extract, Cyclopentasiloxane, Dimethicone, Dimethicone/PEG-10/15 Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexyl Isononanoate, Glycerin, Iodopropynyl Butylcarbamate, Lauryl PEG-9 Polymethylsiloxethyl Dimethicone, Leontopodium Aloinum (Edelweiss) Extract, Penoxyethanol, Peucedanum Ostruthium Leaf Extract, Retinyl Palmitate, Sodium Chloride, Triethoxycaprylylsilane, Water

Other Information

  • Protect product from exessive heat and direct sunlight.You  may report a serious adverse reaction from using this product to Jack Black at 1-877-766-3388

Questions

1-877-766-3388www.getjackblack.com

* Please review the disclaimer below.