NDC 10742-8476 Softlips Watermelon

Dimethicone, Octinoxate, Octisalate, Oxybenzone

NDC Product Code 10742-8476

NDC 10742-8476-1

Package Description: 1 TUBE in 1 BLISTER PACK > 2 g in 1 TUBE

NDC 10742-8476-2

Package Description: 2 TUBE in 1 BLISTER PACK > 2 g in 1 TUBE

NDC 10742-8476-3

Package Description: 3 TUBE in 1 BLISTER PACK > 2 g in 1 TUBE

NDC Product Information

Softlips Watermelon with NDC 10742-8476 is a a human over the counter drug product labeled by The Mentholatum Company. The generic name of Softlips Watermelon is dimethicone, octinoxate, octisalate, oxybenzone. The product's dosage form is stick and is administered via topical form.

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.

Softlips Watermelon 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.


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.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Skin Barrier Activity - [PE] (Physiologic Effect)

Product Labeler Information

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

Labeler Name: The Mentholatum Company
Labeler Code: 10742
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: 04-16-2012 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.

Softlips Watermelon Product Label Images

Softlips Watermelon 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

Dimethicone 2%Octinoxate 7.5%Octisalate 3%Oxybenzone 3%


Dimethicone - Skin protectantOctinoxate - SunscreenOctisalate - SunscreenOxybenzone - Sunscreen

Keep Out Of Reach Of Children

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


  • •helps prevent sunburn •temporarily protects chapped or cracked lips


Skin Cancer/Skin Aging Alert: Spending time in the sun increased your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging. 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 •condition worsens •symptoms last more than 7 days or clear up and occur again within a few days


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

Inactive Ingredients

Ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetate [vitamin E]

* Please review the disclaimer below.