NDC 69231-037 Cle Ccc Cool Deep
Titanium Dioxide, Octinoxate, Octisalate, Avobenzone Cream Topical

Product Information

Cle Ccc Cool Deep is a human over the counter drug product labeled by Kw Absc, Inc.. The generic name of Cle Ccc Cool Deep is titanium dioxide, octinoxate, octisalate, avobenzone. The product's dosage form is cream and is administered via topical form.

Product Code69231-037
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.
Cle Ccc Cool Deep
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.
Titanium Dioxide, Octinoxate, Octisalate, Avobenzone
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 FormCream - 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.
Kw Absc, Inc.
Labeler Code69231
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.
11-09-2022
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

What are the uses for Cle Ccc Cool Deep?


Product Packages

NDC 69231-037-02

Package Description: 1 CONTAINER in 1 PACKAGE > 30 mL in 1 CONTAINER (69231-037-01)

Product Details

What are Cle Ccc Cool Deep 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.

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.
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ADENOSINE (UNII: K72T3FS567)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
  • CHRYSANTHEMUM INDICUM FLOWER (UNII: I6OER6U04L)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • ROSEMARY (UNII: IJ67X351P9)
  • ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
  • THYME (UNII: CW657OBU4N)
  • JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • MALVA SYLVESTRIS FLOWERING TOP (UNII: X1U1U0N90J)
  • ACHILLEA MILLEFOLIUM WHOLE (UNII: 2FXJ6SW4PK)
  • ALCHEMILLA XANTHOCHLORA FLOWERING TOP (UNII: 9M289NKI69)
  • ALCOHOL (UNII: 3K9958V90M)
  • PRIMULA VERIS WHOLE (UNII: W6LFQ57E4M)
  • MENTHA PIPERITA LEAF (UNII: A389O33LX6)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • WATER (UNII: 059QF0KO0R)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CYCLOMETHICONE 6 (UNII: XHK3U310BA)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • AMILOXATE (UNII: 376KTP06K8)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12)
  • MICA (UNII: V8A1AW0880)
  • BEMOTRIZINOL (UNII: PWZ1720CBH)
  • POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • CANDELILLA WAX (UNII: WL0328HX19)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • POLYESTER-10 (UNII: 212N9O2MMZ)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
  • SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • CORN OIL (UNII: 8470G57WFM)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • BERGAMOT OIL (UNII: 39W1PKE3JI)
  • ORANGE OIL (UNII: AKN3KSD11B)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • DIMETHICONOL (2000 CST) (UNII: T74O12AN6Y)
  • YLANG-YLANG OIL (UNII: 8YOY78GNNX)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • LOWBUSH BLUEBERRY (UNII: G90PX41VP0)

* Please review the disclaimer below.

Cle Ccc Cool Deep Labeling and Warnings

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.

Table of Contents



Otc - Active Ingredient



Titanium Dioxide 0.27%

Ethylhexyl Methoxycinnamate 7.00%

Ethylhexyl Salicylate 2.00%

Avobenzone 0.52%


Otc - Purpose



Sunscreen


Indications & Usage



Helps prevent sunburn


Dosage & Administration



Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
Ask a doctor to use for children under 6 months


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.
Stop using and ask a doctor if rash occurs.


Otc - Keep Out Of Reach Of Children



Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.


Inactive Ingredient



Water, Cyclopentasiloxane, CI 77499, Butylene Glycol, Diphenylsiloxy Phenyl Trimethicone, C12-15 Alkyl Benzoate, Isoamyl p-Methoxycinnamate, Cetyl PEG/PPG-10/1 Dimethicone, Cyclohexasiloxane, Niacinamide, CI 77491, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, CI 77492, Polymethyl Methacrylate, Sodium Chloride, Euphorbia Cerifera (Candelilla) Wax, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Sorbitan Olivate, Synthetic Beeswax, Disteardimonium Hectorite, Triethoxycaprylylsilane, Trihydroxystearin, Dipropylene Glycol, Hydroxyacetophenone, Vegetable Oil, Chlorphenesin, Caprylyl Glycol, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Oil, Propylene Carbonate, Dimethiconol, Adenosine, Cananga Odorata Flower Oil, Disodium EDTA, Natto Gum, Saussurea Involucrata Extract, Vaccinium Angustifolium (Blueberry) Fruit Extract, Tocopheryl Acetate, Hydrolyzed Hyaluronic Acid, Dimethicone, Glycerin, Melissa Officinalis Leaf Extract, Chrysanthemum Indicum Flower Extract, Camellia Sinensis Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Aspalathus Linearis Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract, Jasminum Officinale (Jasmine) Flower Water, Veronica Officinalis Extract, Dipotassium Glycyrrhizate, Malva Sylvestris (Mallow) Extract, Achillea Millefolium Extract, Alchemilla Vulgaris Extract, Alcohol, Primula Veris Extract, Mentha Piperita (Peppermint) Leaf Extract, Mica, Tocopherol, Polyester-1, Silica Dimethyl Silylate


* Please review the disclaimer below.