NDC 67777-177 1177, 1178 Sunscreen

1177, 1178 Sunscreen

NDC Product Code 67777-177

NDC 67777-177-01

Package Description: 24 BOX in 1 CASE > 25 PACKET in 1 BOX > 3.5 g in 1 PACKET

NDC 67777-177-02

Package Description: 1000 PACKET in 1 CASE > 3.5 g in 1 PACKET

NDC Product Information

1177, 1178 Sunscreen with NDC 67777-177 is a a human over the counter drug product labeled by Dynarex. The generic name of 1177, 1178 Sunscreen is 1177, 1178 sunscreen. The product's dosage form is cream and is administered via topical form.

Labeler Name: Dynarex

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.

1177, 1178 Sunscreen 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.

  • OXYBENZONE 5 g/100g
  • HOMOSALATE 6 g/100g
  • OCTINOXATE 7.5 g/100g
  • OCTISALATE 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.

  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • EICOSYL POVIDONE (UNII: XQQ9MKE2BJ)
  • SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • PEG-8 DIMETHICONE (UNII: GIA7T764OD)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • 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.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Dynarex
Labeler Code: 67777
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: 05-27-2021 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.

1177, 1178 Sunscreen 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

Homosalate 6%, Octinoxate 7.5%, Octisalate 5%, Oxygenzone 5%

Purpose

Sunscreen

Uses

. Protects from excessive heat and direct sun. Helps prevent sunburns. Higher SPF gives more sunburn protection . For skin highly sensitive to sunburn

Warnings

For External Use Only.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 carcer or early skin aging.

Do Not Use

On damaged or broken skin

When Using This Product

. Keep out of eyes. Rinse with water to remove

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

. Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours. Children under 6 months: as a doctor

Inactive Ingredients

Antaron V-220, Cetyl Alcohol, Germaben II-E, PEG-8 Dimethicone, Petrolatum, Polyoxyl 40 Stearate, Polysorbate 60, Purified Water, Sorbitan Monostearate, Tetrasodium EDTA, Titanium Dioxide, Xanthan Gum

* Please review the disclaimer below.