NDC 81123-314 Cc Cream Deep250

Titanium Dioxide, Zinc Oxide

NDC Product Information

Cc Cream Deep250 with NDC 81123-314 is a a human over the counter drug product labeled by The Creme Shop Inc. The generic name of Cc Cream Deep250 is titanium dioxide, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: The Creme Shop Inc

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 Deep250 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.

  • TITANIUM DIOXIDE 5.5 mg/100mL
  • ZINC OXIDE 5.5 mg/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)
  • ISODODECANE (UNII: A8289P68Y2)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • CERESIN (UNII: Q1LS2UJO3A)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • DEHYDROACETIC ACID (UNII: 2KAG279R6R)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)
  • ROSA CENTIFOLIA FLOWER (UNII: CS4TE8FF7O)
  • ORANGE (UNII: 5EVU04N5QU)
  • SOYBEAN (UNII: L7HT8F1ZOD)
  • BEACH STRAWBERRY (UNII: 98542F2TQS)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • GARCINIA INDICA SEED BUTTER (UNII: US2H3D7800)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • RICE GERM (UNII: 7N2B70SFEZ)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • COCONUT (UNII: 3RT3536DHY)
  • PEACH (UNII: 3OKE88I3QG)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • ADENOSINE (UNII: K72T3FS567)
  • CANOLA OIL (UNII: 331KBJ17RK)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • CENTELLA ASIATICA (UNII: 7M867G6T1U)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • MAGNESIUM MYRISTATE (UNII: Z1917F0578)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)

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: The Creme Shop Inc
Labeler Code: 81123
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 NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final. 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: 12-11-2020 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 Cream Deep250 Product Label Images

Cc Cream Deep250 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

Titanium Dioxide 5.5%

Zinc Oxide 5.5%

Purpose

Helps prevent sunburn.

Uses

If uses as directed with other sun protection measures(see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Warnings

For external use only.

Rinse with water to remove.

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

Do not use on damaged or broken skin.

Keep out of reach of children.

Stop use and ask a doctor if rash occurs.

Directions

Apply liberally 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 skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 of higher and other sun protection measures including:

Limit time in the sun, especially from 10 a.m. - 2 p.m.

Wear long-sleeve shirts, pants, hats, and sunglasses.

Children under 6months of age: Ask a doctor.

Other Information

Protect the product in this container from excessive heart and direct sun.

Inactive Ingredient

Water, Sea Water, Dimethicone, Isododecane, Iron Oxide Yellow, Caprylic/Capric Triglyceride, Cetyl PEG/PPG-10/1 Dimethicone, Phenyl Trimethicone, Iron Oxide Red, Sodium Chloride, Butylene Glycol, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Iron Oxide Black, Phenoxyethanol, Sorbitan Isostearate, Triethoxycaprylylsilane, Ceresin, Silica, Magnesium Myristate, Magnesium Stearate, Sorbitan Sesquioleate, 1,2-Hexanediol, Synthetic Wax, Dimethicone/Vinyl Dimethicone Crosspolymer, Aluminum Hydroxide, Ethylhexylglycerin, Dehydroacetic Acid, Disteardimonium Hectorite, Methicone, Adenosine, Propylene Carbonate, Canola Oil, Garcinia Indica Seed Butter, Helianthus Annuus (Sunflower) Seed Oil, Lavandula Angustifolia (Lavender) Oil, Vitis vinifera (Grape) seed oil, Rose Centifolia Flower Extract, Citrus Aurantium Dulcis (Orange) Fruit Extract, Centella Asiatica Extract, Glycerin, Glycine Soja (Soybean) Seed Extract, Aloe Barbadensis Leaf Extract, Camellia Sinensis Leaf Extract, Cocos Nucifera (Coconut) Fruit Extract, Oryza Sativa (Rice) Extract, Prunus Persica (Peach) Fruit Extract, Fragaria Chiloensis (Strawberry) Fruit Extract, Sodium Hyaluronate

* Please review the disclaimer below.