NDC 74997-0015 W.skin Triple Care Sun

Octocrylene

NDC Product Code 74997-0015

NDC 74997-0015-1

Package Description: 17 g in 1 PACKAGE

NDC Product Information

W.skin Triple Care Sun with NDC 74997-0015 is a a human over the counter drug product labeled by J&j Company. The generic name of W.skin Triple Care Sun is octocrylene. The product's dosage form is stick and is administered via topical form.

Labeler Name: J&j Company

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.

W.skin Triple Care Sun 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.

  • OCTOCRYLENE 8.5 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.

  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)

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: J&j Company
Labeler Code: 74997
Marketing Category: UNAPPROVED DRUG OTHER - 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: 05-08-2021 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.

W.skin Triple Care Sun Product Label Images

W.skin Triple Care Sun 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

Octocrylene

Inactive Ingredient

Cetyl Ethylhexanoate, Ethylhexyl Palmitate, Synthetic Wax, Octocrylene, Dimethicone, Ceresin, Ethylhexyl Methoxycinnamate, Ethylhexyl Salicylate , Methyl Methacrylate Crosspolymer, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Dicaprylyl Carbonate, Butylene Glycol Dicaprylate/Dicaprate, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Microcrystalline Wax, Cyclopentasiloxane, Sorbitan Olivate, Dimethicone/Vinyl Dimethicone Crosspolymer, Disteardimonium Hectorite, Centella Asiatica Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Daucus Carota Sativa (Carrot) Root Extract, Citrullus Vulgaris (Watermelon) Fruit Extract, Solanum Lycopersicum (Tomato) Fruit Extract, Pyrus Malus (Apple) Fruit Extract, Fragaria Ananassa (Strawberry) Fruit Extract, Prunus Serotina (Wild Cherry) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract, Prunus Salicina Fruit Extract, Vaccinium Macrocarpon (Cranberry) Fruit Extract, Punica Granatum Fruit Extract, Citrus Paradisi (Grapefruit) Seed Extract, Capsicum Annuum Fruit Extract, Capsicum Annuum Extract, Psidium Guajava Fruit Extract, Wine Extract, Caprylyl Glycol, Triethyl Citrate, Tocopheryl Acetate, Ethylhexylglycerin, Fragrance, Geraniol, Butylphenyl Methylpropional, Limonene, Linalool

Otc - Purpose

It has a strong sun block and waterproof function. Matt type sun stick that applies lightly and smoothly without any stickiness and residue.

Otc - Keep Out Of Reach Of Children

Keep out of reach of the children

Indications & Usage

Apply lightly on exposed skin 2~3 times

Warnings

If there are any abnormal symptoms or side effects such as red spots, swelling, or itching due to direct sunlight during or after using cosmetics. 2. Avoid using areas with wounds. 3. Precautions for storage and handling. 3.1) Keep out reach of children. 3.2) Keep it out of direct sunlight.

Dosage & Administration

For external use only

* Please review the disclaimer below.