NDC 75936-202 Cc Cream Broad Spectrum Sunscreen Spf 35 Fair To Light

Titanium Dioxide, Zinc Oxide

NDC Product Code 75936-202

NDC CODE: 75936-202

Proprietary Name: Cc Cream Broad Spectrum Sunscreen Spf 35 Fair To Light 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: Titanium Dioxide, Zinc Oxide 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.

NDC Code Structure

  • 75936 - Taylor James Ltd
    • 75936-202 - Cc Cream Broad Spectrum Sunscreen Spf 35 Fair To Light

NDC 75936-202-02

Package Description: 1 BOTTLE in 1 BOX > 47 mL in 1 BOTTLE (75936-202-01)

NDC Product Information

Cc Cream Broad Spectrum Sunscreen Spf 35 Fair To Light with NDC 75936-202 is a a human over the counter drug product labeled by Taylor James Ltd. The generic name of Cc Cream Broad Spectrum Sunscreen Spf 35 Fair To Light is titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Taylor James Ltd

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Cc Cream Broad Spectrum Sunscreen Spf 35 Fair To Light 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.

  • ZINC OXIDE 20 g/100mL

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.

  • WATER (UNII: 059QF0KO0R)
  • APPLE (UNII: B423VGH5S9)
  • MICA (UNII: V8A1AW0880)

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: Taylor James Ltd
Labeler Code: 75936
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: 05-11-2018 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: 12-31-2021 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.

Cc Cream Broad Spectrum Sunscreen Spf 35 Fair To Light Product Label Images

Cc Cream Broad Spectrum Sunscreen Spf 35 Fair To Light 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 - Purpose

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help orcontact a Poison Control Center right away.

Indications & Usage

Stop use and ask a doctor if rash occurs


Warnings· 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.

Dosage & Administration

Directions· Apply liberally and evenly 15 minutes before sun exposure· Reapply at least every 2 hours· Use a water resistant sunscreen if swimming or sweating· Sun Protection Measures. Spending time in the sun increases your risk of skincancer and early skin aging. To decrease this risk, regularly use a sunscreenwith broad spectrum SPF of 15 or higher and other sun protection measuresincluding:· limit time in the sun, especially from 10 a.m. - 2 p.m.· wear long-sleeve shirts, pants, hats, and sunglasses· Children under 6 months: Ask a doctor

Inactive Ingredient

Inactive Ingredients Water, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Isododecane, Glycerin, Propanediol, Cetyl Diglyceryl, Tris(Trimethylsiloxy)Silyethyl Dimethicone, 1-2-Hexandiol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Iron Oxides, Triethoxycaprylylsilane, Mica, Hydroxyacetophenone, Silica, Titanium Dioxide, Dimethicone/Vinyl Dimethicone Crosspolymer, Trisodium Ethylenediamine Disuccinate, Chlorphenesin, Tin Oxide, Tocopherol, Chondrus Crispus Extract, Sodium Hyaluronate

* Please review the disclaimer below.