NDC 49035-665 Equate Moisture Spf 15 Lip Balm

Oxybenzone, Octinoxate, Petrolatum

NDC Product Code 49035-665

NDC Code: 49035-665

Proprietary Name: Equate Moisture Spf 15 Lip Balm Additional informationCallout TooltipWhat 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: Oxybenzone, Octinoxate, Petrolatum Additional informationCallout TooltipWhat 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.


Code Structure
  • 49035 - Walmart
    • 49035-665 - Equate Moisture Spf 15 Lip Balm

NDC 49035-665-05

Package Description: 1 g in 1 CONTAINER

NDC Product Information

Equate Moisture Spf 15 Lip Balm with NDC 49035-665 is a a human over the counter drug product labeled by Walmart. The generic name of Equate Moisture Spf 15 Lip Balm is oxybenzone, octinoxate, petrolatum. The product's dosage form is stick and is administered via topical form.

Labeler Name: Walmart

Dosage Form: Stick - A dosage form prepared in a relatively long and slender often cylindrical form.

Product Type: Human Otc Drug Additional informationCallout TooltipWhat 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.


Equate Moisture Spf 15 Lip Balm Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTINOXATE 7.5 mg/g
  • OXYBENZONE 3.5 mg/g
  • PETROLATUM 40.7 mg/g

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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.

  • CERESIN (UNII: Q1LS2UJO3A)
  • LIGHT MINERAL OIL (UNII: N6K5787QVP)
  • ISOCETYL STEARATE (UNII: 3RJ7186O9W)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • LANOLIN (UNII: 7EV65EAW6H)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Walmart
Labeler Code: 49035
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 03-29-2019 Additional informationCallout TooltipWhat 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: 12-31-2020 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Equate Moisture Spf 15 Lip Balm Product Label Images

Equate Moisture Spf 15 Lip Balm 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 Ingredient

Octinoxate (7.5%), Oxybenzone (3.5%)Petrolatum (40.7%)

Purpose

Sunscreen, Sunscreen, Skin Protectant

Keep Out Of Reach Of Children

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

Uses

Helps prevent sunburn. Helps prevent and temporarily protects dry, chapped or windburned lips.

Warnings

Skin Cancer/Skin Aging Alert: 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 cancer or early aging. For external use only: Stop use and ask a doctor: if rash or irritation develops and lasts.

Directions

Apply liberally before sun exposure and as needed. Children under 6 months of age: Ask a doctor before use.

Inactive Ingredients

Ozokerite, Mineral Oil, Isocetyl Stearate, Microcrystalline Wax, Isopropyl Lanolate, Lanolin, Copernicia Cerifera (Carnauba) Wax, Tocopheryl Acetate, Isopropyl Myristate, Aloe Barbadenis Leaf Extract, Paraffin, Cetyl Alcohol, Tocerpheryl Linoleate, Flavor, Methylparaben, Propylparaben.

* Please review the disclaimer below.

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