NDC 52060-007 Peppermint Lip Balm Spf 15

Octinoxate, Oxybenzone

NDC Product Code 52060-007

NDC 52060-007-01

Package Description: 4.25 g in 1 TUBE

NDC Product Information

Peppermint Lip Balm Spf 15 with NDC 52060-007 is a a human over the counter drug product labeled by Natural Star Labs, Ltd. The generic name of Peppermint Lip Balm Spf 15 is octinoxate, oxybenzone. The product's dosage form is stick and is administered via topical form.

Labeler Name: Natural Star Labs, Ltd

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

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.

Peppermint Lip Balm Spf 15 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 4.5 g/100g
  • OCTINOXATE 2 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.

  • CORN OIL (UNII: 8470G57WFM)

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.
  • 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: Natural Star Labs, Ltd
Labeler Code: 52060
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: 10-07-2019 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: 12-31-2020 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 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Peppermint Lip Balm Spf 15 Product Label Images

Peppermint Lip Balm Spf 15 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



Otc - Active Ingredient

Active Ingredients:Octinoxate 2.0%Oxybenzone 4.5%

Otc - Purpose

PurposeOctinoxate ........SunscreenOxybenzone ......Sunscreen

Indications & Usage

Uses: Helps prevent sunburn • Helps prevent andtemporarily protect dry, chapped or windburned lips.


WarningsSkin Cancer/Skin Aging Alert: Spending time in the sunincreases your risk of skin cancer and early skin aging. Thisproduct has been shown only to prevent sunburn, not skincancer or early aging.

Other Safety Information

For external use only

Otc - Stop Use

Stop use and ask a doctor: If rash or irritation developsand lasts.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children: If swallowed, get medicalhelp or contact a Poison Control Center right away.

Dosage & Administration

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

Inactive Ingredient

Inactive ingredients: Synthetic Beeswax, HelianthusAnnuus (Sun¬flower) Seed Oil, Ricinus Communis (Castor)Seed Oil, Lanolin, Cocos Nucifera (Coconut) Oil, MenthaPiperita (Peppermint) Oil, Zea Mays (Corn) Oil (and) BHT,Tocopheryl Acetate, BHT.

* Please review the disclaimer below.