NDC 41167-0435 Gold Bond Ultimate Neck And Chest Age Defense Cream With Spf 20

Avobenzone, Octisalate, Octocrylene

NDC Product Code 41167-0435

NDC CODE: 41167-0435

Proprietary Name: Gold Bond Ultimate Neck And Chest Age Defense Cream With Spf 20 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: Avobenzone, Octisalate, Octocrylene 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

  • 41167 - Chattem, Inc.
    • 41167-0435 - Gold Bond Ultimate Neck And Chest Age Defense Cream With Spf 20

NDC 41167-0435-0

Package Description: 1 TUBE in 1 CARTON > 48 g in 1 TUBE

NDC Product Information

Gold Bond Ultimate Neck And Chest Age Defense Cream With Spf 20 with NDC 41167-0435 is a a human over the counter drug product labeled by Chattem, Inc.. The generic name of Gold Bond Ultimate Neck And Chest Age Defense Cream With Spf 20 is avobenzone, octisalate, octocrylene. The product's dosage form is cream and is administered via topical form.

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.

Gold Bond Ultimate Neck And Chest Age Defense Cream With Spf 20 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.

  • WATER (UNII: 059QF0KO0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • BEHENTRIMONIUM METHOSULFATE (UNII: 5SHP745C61)
  • STEARETH-21 (UNII: 53J3F32P58)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • SELAGINELLA LEPIDOPHYLLA (UNII: 02JQ564P1G)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATERMELON (UNII: 231473QB6R)
  • CERAMIDE NP (UNII: 4370DF050B)
  • LENS CULINARIS FRUIT (UNII: ZYZ076G9JH)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • APPLE (UNII: B423VGH5S9)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • GINGER (UNII: C5529G5JPQ)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • EDETATE DIPOTASSIUM ANHYDROUS (UNII: 3W5S57M958)
  • HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • 3-O-ETHYL ASCORBIC ACID (UNII: 6MW60CB71P)
  • CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
  • POLYISOBUTYLENE (1000 MW) (UNII: 5XB3A63Y52)
  • DIMETHICONOL (100000 CST) (UNII: OSA9UP217S)
  • SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) (UNII: 1DXE3F3OZX)
  • HYDROGENATED JOJOBA OIL, RANDOMIZED (UNII: Q47ST02F58)

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: Chattem, Inc.
Labeler Code: 41167
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: 08-01-2019 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: 12-31-2021 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.

Gold Bond Ultimate Neck And Chest Age Defense Cream With Spf 20 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

Purpose

Avobenzone 3%, Octisalate 5%, Octocrylene 10%.....................................................................................Sunscreen

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 Doctor If

■ rash occurs

Keep Out Of Reach Of Children.

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

Directions

■ for sunscreen use:
     
■ apply liberally 15 minutes before sun exposure  ■ reapply at least every 2 hours ■ use a water resistant sunscreen if swimming or sweating ■ children under 6 months: ask a doctor■ 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

Other Information

■ protect the product in this container from excessive heat and direct sun

Inactive Ingredients

Water, dimethicone, niacinamide, behentrimonium methosulfate, steareth-21, cetyl alcohol, cetyl dimethicone, glyceryl stearate, selaginella lepidophylla extract, glycerin, citrullus lanatus (watermelon) fruit extract, ceramide NP, lens esculenta (lentil) fruit extract, sodium PCA, cetearyl alcohol, polysorbate 60, butylene glycol, polyisobutene, pyrus malus (apple) fruit extract, polysorbate 20, cyclopentasiloxane, sodium lactate, dimethiconol, polyacrylate crosspolymer-6, xanthan gum, hydroxyacetophenone, ethylhexylglycerin, fragrance, methylparaben, bisabolol, zingiber officinale (ginger) root extract, polyacrylate-13, tocopheryl acetate, dipotassium EDTA, hydrolyzed jojoba esters, jojoba esters, sodium hyaluronate, 3-O-ethyl ascorbic acid

* Please review the disclaimer below.