NDC 79753-017 Coola Full Spectrum 360 Day Eye Cream Spf 30

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 79753-017

NDC CODE: 79753-017

Proprietary Name: Coola Full Spectrum 360 Day Eye Cream Spf 30 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: Avobenzone, Homosalate, Octisalate, Octocrylene 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

  • 79753 - Coola Llc
    • 79753-017 - Coola Full Spectrum 360 Day Eye Cream Spf 30

NDC 79753-017-01

Package Description: 1 JAR in 1 CARTON > 24 mL in 1 JAR

NDC Product Information

Coola Full Spectrum 360 Day Eye Cream Spf 30 with NDC 79753-017 is a a human over the counter drug product labeled by Coola Llc. The generic name of Coola Full Spectrum 360 Day Eye Cream Spf 30 is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is cream and is administered via topical form.

Labeler Name: Coola Llc

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.

Coola Full Spectrum 360 Day Eye Cream Spf 30 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.

  • AVOBENZONE 2 g/100mL
  • HOMOSALATE 2 g/100mL
  • OCTISALATE 3 g/100mL
  • OCTOCRYLENE 5 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.

  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ALOE VERA FLOWER (UNII: 575DY8C1ER)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETYL PALMITATE (UNII: 5ZA2S6B08X)
  • COCCINIA GRANDIS LEAF (UNII: YJE89UL5PL)
  • CORALLINA OFFICINALIS (UNII: 4004498D06)
  • TURMERIC (UNII: 856YO1Z64F)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ISODODECANE (UNII: A8289P68Y2)
  • JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)
  • AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
  • HOLY BASIL LEAF (UNII: SCJ765569P)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
  • EGGPLANT (UNII: W5K7RAS4VK)
  • SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
  • SORBITAN MONOPALMITATE (UNII: 77K6Z421KU)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • COCOA (UNII: D9108TZ9KG)
  • TROPOLONE (UNII: 7L6DL16P1T)
  • WATER (UNII: 059QF0KO0R)

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: Coola Llc
Labeler Code: 79753
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: 02-08-2021 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: 12-31-2022 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.

Coola Full Spectrum 360 Day Eye Cream Spf 30 Product Label Images

Coola Full Spectrum 360 Day Eye Cream Spf 30 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

Drug FactsActive IngredientsAvobenzone 2.0%, Homosalate 2.0%, Octisalate 3.0%, Octocrylene 5.0%

Otc - Purpose

Purpose .........Suncreen

Indications & Usage

  • Uses  • 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

Warnings

WarningsFor external use only • Do not use on damaged or broken skinWhen using this product keep out of eyes. Rinse with water to remove. • Stop use and ask doctor ifskin rash occurs • Keep out of reach of children. If product is swallowed, get medical help or contacta Poison Control Center right away.

Dosage & Administration

Directions • apply liberally 15 minutes before sun exposure. • reapply: ● after 80 minutes of swimming or sweating● immediately after towel drying ● at least every 2 hours • Sun Protection Measures. Spending time inthe sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use asunscreen with a broad spection SPF 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-sleeve shirts, pants, hats, andsunglasses ●Children under 6 months: Ask a doctor

Inactive Ingredient

Inactive Ingredients 1,2-HEXANEDIOL, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice(ORGANIC), Amino Esters-1(JPN), Butylene Glycol, C12-15 Alkyl Benzoate, Caprylyl Glycol, Carthamus Tinctorius(Safflower) Oleosomes, Cetearyl Alcohol , Cetyl Palmitate, Coccinia Indica Fruit Extract, Corallina Officinalis Extract,Corallina Officinalis Powder, Curcuma Longa (Turmeric) Root Extract, Dimethicone, Dimethicone Crosspolymer,Glycerin (ORGANIC), Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, Melia Azadirachta Flower Extract,Melia Azadirachta Leaf Extract, Neopentyl Glycol Diheptanoate, Ocimum Basilicum (Basil) Flower/Leaf Extract,Ocimum Sanctum Leaf Extract, Parfum, Polyacrylate Crosspolymer-6, Propanediol, Schinus Molle Extract, Silica,Sodium Hydroxide, Sodium Phytate, Sodium Polyacrylate, Sodium Melongena (Eggplant) Fruit Extract, SorbitanOleate, Sorbitan Palmitate, Tetrahexyldecyl Ascorbate, Theobroma Cacao (Cocoa) Seed Extract, Tropolone, Water

Other Safety Information

Other information • protect this product from excessive heat and direct sun

Otc - Questions

Questions or comments? Call 760-940-2125

Coola Label

SPF 3070%+ OrganicCOOLA​®Day SPF 30 & NightEye Cream DuoFull 360° SpectrumWith Vitamin C & ResveratrolStress from Blue Light, Pollution & FatigueBroad Spectrum SPF 300.8 FL OZ / 24 mL©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92010.  All Rights Reserved.  www.coola.com*Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Freeres

* Please review the disclaimer below.