NDC 75936-219 Cc Screen 100% Mineral Cc Cream Broad Spectrum Spf 50 110c

Titanium Dioxide, Zinc Oxide

NDC Product Code 75936-219

NDC 75936-219-01

Package Description: 47 mL in 1 TUBE

NDC Product Information

Cc Screen 100% Mineral Cc Cream Broad Spectrum Spf 50 110c with NDC 75936-219 is a a human over the counter drug product labeled by Taylor James, Ltd.. The generic name of Cc Screen 100% Mineral Cc Cream Broad Spectrum Spf 50 110c 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 Screen 100% Mineral Cc Cream Broad Spectrum Spf 50 110c 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
  • TITANIUM DIOXIDE 4 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.

  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ISODODECANE (UNII: A8289P68Y2)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • STANNIC OXIDE (UNII: KM7N50LOS6)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • APPLE (UNII: B423VGH5S9)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • WATER (UNII: 059QF0KO0R)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)

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: 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: 05-28-2020 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 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.

Cc Screen 100% Mineral Cc Cream Broad Spectrum Spf 50 110c Product Label Images

Cc Screen 100% Mineral Cc Cream Broad Spectrum Spf 50 110c 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 PurposeTitanium Dioxide 4% SunscreenZinc Oxide 20% Sunscreen

Otc - Purpose

  • UsesHelps Prevent SunburnIf 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 or contact a poison Control Center right away

Indications & Usage

Stop use and ask a doctor if rash occurs.

Warnings

  • WarningsFor external use onlyDo not use on damaged or broken skin
  • When using this product keep out of eyes. Rinse with water to remove

Dosage & Administration

DirectionsApply generously and evenly 15 minutes before sun exposure

Use a water-resistant sunscreen if swimming or sweating

Reapply at least every 2 hours.

Sun Protection Measures Spending time in the sun increases your risk of

skin cancer and early skin aging. To decrease this risk, regularly use a

sunscreen with a Broad-Spectrum SPF value of 15 or higher and other sun

protection measures including:
• limit your time in the sun, especially from 10

a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
• Children under 6 months of age: ask a doctor.

Inactive Ingredient

Inactive IngredientsWater, C12-15 Alkyl Benzonate, Butyoctyl Salicylate, Isododecane, Propanediol, Glycerin, Cetyl Diglyceryl Tris(Trimethylsiloxy) siloxysilylethyl Dimethicone, Iron Oxides, 1,2-Hexanediol, Pyrus Malus (Apple) Fruit Extract, Sodium Chloride, Silica, Triethoxycaprylylsilane, Dimethicone/Vinyl Dimethicone Crosspolymer, Hydroxyacetophenone, Mica, Diethylhexyl Syringylidenemalonate, Titanium Dioxide, Trisodium Ethylenediamine Disucinate, Chlorphenesin, Xanthan Gum, Chondrus Crispus Extract, Caprylic/Capric Triglyceride, Tin Oxide, Sodium Hyaluronate, Tocopherol

* Please review the disclaimer below.