NDC 68745-2150 Cc Super Active Complete Correction Sunscreen Broad Spectrum Spf 50 10 Beige
Ensulizole, Homosalate, Octisalate, Titanium Dioxide, And Zinc Oxide Cream Topical

Product Information

What is NDC 68745-2150?

The NDC code 68745-2150 is assigned by the FDA to the product Cc Super Active Complete Correction Sunscreen Broad Spectrum Spf 50 10 Beige which is a human over the counter drug product labeled by Chanel Parfums Beaute. The generic name of Cc Super Active Complete Correction Sunscreen Broad Spectrum Spf 50 10 Beige is ensulizole, homosalate, octisalate, titanium dioxide, and zinc oxide. The product's dosage form is cream and is administered via topical form. The product is distributed in a single package with assigned NDC code 68745-2150-1 1 tube in 1 carton / 30 ml in 1 tube. This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information, RxNorm crosswalk and the complete product label.

NDC Product Code	68745-2150
Proprietary Name 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.	Cc Super Active Complete Correction Sunscreen Broad Spectrum Spf 50 10 Beige
Non-Proprietary Name 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.	Ensulizole, Homosalate, Octisalate, Titanium Dioxide, And Zinc Oxide
Substance Name What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.	Ensulizole; Homosalate; Octisalate; Titanium Dioxide; Zinc Oxide
Product Type 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.	Human Otc Drug
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.
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.	Chanel Parfums Beaute
Labeler Code	68745
FDA Application Number 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.	part352
Marketing Category 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.	OTC MONOGRAPH NOT FINAL - A product marketed pursuant to an Over-the-Counter (OTC) Drug Monograph that is not final.
Start Marketing Date What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.	03-10-2023
Listing Expiration Date 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.	12-31-2023
Exclude Flag 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".	N
NDC Code Structure	68745 - Chanel Parfums Beaute 68745-2150 - Cc 68745-2150-1

What are the uses for Cc Super Active Complete Correction Sunscreen Broad Spectrum Spf 50 10 Beige?

This product is used as Active ingredientsPurposeEnsulizole 2.7%SunscreenHomosalate 9%SunscreenOctisalate 4.5%SunscreenTitanium Dioxide 9.7%SunscreenZinc Oxide 15.2%Sunscreen. Helps 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.

Product Packages

NDC Code 68745-2150-1

Package Description: 1 TUBE in 1 CARTON / 30 mL in 1 TUBE

Product Details

What are Cc Super Active Complete Correction Sunscreen Broad Spectrum Spf 50 10 Beige Active Ingredients?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

ENSULIZOLE 27 mg/mL
HOMOSALATE 90 mg/mL
OCTISALATE 45 mg/mL
TITANIUM DIOXIDE 97 mg/mL
ZINC OXIDE 152 mg/mL - A mild astringent and topical protectant with some antiseptic action. It is also used in bandages, pastes, ointments, dental cements, and as a sunblock.

Cc Super Active Complete Correction Sunscreen Broad Spectrum Spf 50 10 Beige Active Ingredients UNII Codes

ENSULIZOLE (UNII: 9YQ9DI1W42)
ENSULIZOLE (UNII: 9YQ9DI1W42) (Active Moiety)
HOMOSALATE (UNII: V06SV4M95S)
HOMOSALATE (UNII: V06SV4M95S) (Active Moiety)
OCTISALATE (UNII: 4X49Y0596W)
OCTISALATE (UNII: 4X49Y0596W) (Active Moiety)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (Active Moiety)
ZINC OXIDE (UNII: SOI2LOH54Z)
ZINC OXIDE (UNII: SOI2LOH54Z) (Active Moiety)

Cc Super Active Complete Correction Sunscreen Broad Spectrum Spf 50 10 Beige Inactive Ingredients UNII Codes

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)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F)
ALCOHOL (UNII: 3K9958V90M)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ARGININE (UNII: 94ZLA3W45F)
STEARIC ACID (UNII: 4ELV7Z65AP)
ALUMINUM OXIDE (UNII: LMI26O6933)
METHYLPROPANEDIOL (UNII: N8F53B3R4R)
KAKADU PLUM (UNII: 0ZQ1D2FDLI)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
LYSINE (UNII: K3Z4F929H6)
HYALURONIC ACID (UNII: S270N0TRQY)
SILANETRIOL (UNII: E52D0J3TS5)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIPROPYLENE GLYCOL (UNII: E107L85C40)
TOCOPHEROL (UNII: R0ZB2556P8)
ULTRAMARINE BLUE (UNII: I39WR998BI)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
MICA (UNII: V8A1AW0880)

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Cc Super Active Complete Correction Sunscreen Broad Spectrum Spf 50 10 Beige Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents

OTHER
OTC - PURPOSE
USES
WARNINGS
OTC - DO NOT USE
OTC - WHEN USING
OTC - STOP USE
OTC - KEEP OUT OF REACH OF CHILDREN
DIRECTIONS
OTHER INFORMATION
INACTIVE INGREDIENTS
QUESTIONS OR COMMENTS?
PRINCIPAL DISPLAY PANEL - 30 ML TUBE CARTON - 10 BEIGE
PRINCIPAL DISPLAY PANEL - 30 ML TUBE CARTON - 20 BEIGE
PRINCIPAL DISPLAY PANEL - 30 ML TUBE CARTON - 30 BEIGE
PRINCIPAL DISPLAY PANEL - 30 ML TUBE CARTON - 40 BEIGE
PRINCIPAL DISPLAY PANEL - 30 ML TUBE CARTON - 50 BEIGE
PRINCIPAL DISPLAY PANEL - 30 ML TUBE CARTON - 60 BEIGE
PRINCIPAL DISPLAY PANEL - 30 ML TUBE CARTON - 70 BEIGE

Other

Drug Facts

Otc - Purpose

Active ingredients	Purpose
Ensulizole 2.7%	Sunscreen
Homosalate 9%	Sunscreen
Octisalate 4.5%	Sunscreen
Titanium Dioxide 9.7%	Sunscreen
Zinc Oxide 15.2%	Sunscreen

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.

Warnings

For external use only.

Otc - Do Not Use

Do not use on damaged or broken skin.

Otc - When Using

When using this product keep out of eyes. Rinse with water to remove.

Otc - Stop Use

Stop use and ask a doctor if skin rash occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:
- apply liberally 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 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

Other Information

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

Inactive Ingredients

CHANEL

30 ml
1 FL.OZ.

PRINCIPAL DISPLAY PANEL - 30 ml Tube Carton - 70 Beige - sunscreen 07

* Please review the disclaimer below.