NDC 0573-2028 Chapstick

Avobenzone, Octinoxate, And White Petrolatum

NDC Product Code 0573-2028

NDC CODE: 0573-2028

Proprietary Name: Chapstick 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, Octinoxate, And White Petrolatum 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.

Product Characteristics

Flavor(s):
STRAWBERRY (C73417)
CHERRY (C73375)

NDC Code Structure

NDC 0573-2028-01

Package Description: 1 KIT in 1 PACKAGE * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER

NDC 0573-2028-02

Package Description: 1 KIT in 1 PACKAGE * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER * 4 g in 1 CYLINDER

NDC Product Information

Chapstick with NDC 0573-2028 is a a human over the counter drug product labeled by Glaxosmithkline Consumer Healthcare Holdings (us) Llc. The generic name of Chapstick is avobenzone, octinoxate, and white petrolatum. The product's dosage form is kit and is administered via form.

Dosage Form: Kit - A packaged collection of related material.

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.

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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOCETYL STEARATE (UNII: 3RJ7186O9W)
  • LANOLIN (UNII: 7EV65EAW6H)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • SACCHARIN (UNII: FST467XS7D)
  • .ALPHA.-TOCOPHEROL LINOLEATE, D- (UNII: G0N132Q0ED)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LANOLIN (UNII: 7EV65EAW6H)
  • LEMON OIL (UNII: I9GRO824LL)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • MALTOL (UNII: 3A9RD92BS4)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • D&C RED NO. 6 (UNII: 481744AI4O)
  • SACCHARIN (UNII: FST467XS7D)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LANOLIN (UNII: 7EV65EAW6H)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • LEVOMENTHOL (UNII: BZ1R15MTK7)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • D&C RED NO. 6 (UNII: 481744AI4O)
  • SACCHARIN (UNII: FST467XS7D)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • ARACHIDYL PROPIONATE (UNII: QV5DAH3MSB)
  • CAMPHOR (NATURAL) (UNII: N20HL7Q941)
  • CARNAUBA WAX (UNII: R12CBM0EIZ)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
  • LANOLIN (UNII: 7EV65EAW6H)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • OCTYLDODECANOL (UNII: 461N1O614Y)
  • OLEYL ALCOHOL (UNII: 172F2WN8DV)
  • PARAFFIN (UNII: I9O0E3H2ZE)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • D&C RED NO. 6 (UNII: 481744AI4O)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • WHITE WAX (UNII: 7G1J5DA97F)
  • FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Product Labeler Information

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

Labeler Name: Glaxosmithkline Consumer Healthcare Holdings (us) Llc
Labeler Code: 0573
FDA Application Number: part347 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: 06-28-2021 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.

Chapstick Product Label Images

Chapstick 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%Octinoxate 7.5%White petrolatum 42.3%

Purposes

SunscreensSkin protectant

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▪helps prevent and temporarily protects chafed, chapped or cracked lips▪helps prevent and protect from the drying effects of wind and cold weather

  • ▪helps prevent and temporarily protects chafed, chapped or cracked lips▪helps prevent and protect from the drying effects of wind and cold weather

Warnings

For external use only

For external use only

Otc - Do Not Use

Do not use on damaged or broken skin

Otc - Stop Use

Stop use and ask a doctor if rash occurs

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Keep Out Of Reach Of Children

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▪use a water resistant sunscreen if swimming or sweating▪children under 6 months of age: 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:▪limited time in the sun, especially from 10 a.m. – 2 p.m.▪wear long-sleeved shirts, pants, hats, and sunglasses

Apply as needed

Other Information

  • ▪store at 20-25°C (68-77°F)▪protect this product from excessive heat and direct sun

Store at 20-25°C (68-77°F)

Inactive Ingredients

Aloe barbadensis leaf extract, carnauba wax, cetyl alcohol, fragrance, isocetyl stearate, isopropyl lanolate, lanolin, mineral oil, paraffin, saccharin, tocopheryl linoleate/oleate, vitamin E acetate, white wax

Active Ingredient

White petrolatum 45%

Purpose

Skin Protectant

Inactive Ingredients (Classic Original)

Arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, octyldodecanol, oleyl alcohol, paraffin, phenyl trimethicone, red 6 lake, titanium dioxide, white wax, yellow 5 lake

Inactive Ingredients (Classic Cherry)

Arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, light mineral oil, menthol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Inactive Ingredients (Classic Strawberry)

Arachidyl propionate, camphor, carnauba wax, cetyl alcohol, fragrance, isopropyl lanolate, isopropyl myristate, lanolin, lemon oil, light mineral oil, maltol, octyldodecanol, paraffin, phenyl trimethicone, red 6 lake, saccharin, white wax

Additional Information

Paraben FreeDistributed by: GSK Consumer Healthcare, Warren, NJ 07059For most recent product information, visit www.chapstick.comTrademarks owned or licensed by GSK ©2021 GSK or licensor

* Please review the disclaimer below.