NDC 79753-020 Coola Full Spectrum 360 Refreshing Water Cream Spf 50

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 79753-020

NDC CODE: 79753-020

Proprietary Name: Coola Full Spectrum 360 Refreshing Water Cream Spf 50 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

NDC 79753-020-01

Package Description: 1 JAR in 1 CARTON > 44 mL in 1 JAR

NDC 79753-020-02

Package Description: 1 JAR in 1 CARTON > 15 mL in 1 JAR

NDC Product Information

Coola Full Spectrum 360 Refreshing Water Cream Spf 50 with NDC 79753-020 is a a human over the counter drug product labeled by Coola Llc. The generic name of Coola Full Spectrum 360 Refreshing Water Cream Spf 50 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 Refreshing Water Cream Spf 50 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 3 g/100mL
  • HOMOSALATE 5 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.

  • ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
  • ALOE VERA FLOWER (UNII: 575DY8C1ER)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • P-ANISALDEHYDE (UNII: 9PA5V6656V)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • BENZYL ACETATE (UNII: 0ECG3V79ZJ)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
  • CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCCINIA GRANDIS LEAF (UNII: YJE89UL5PL)
  • COCONUT WATER (UNII: 267F5Y81NT)
  • CORALLINA OFFICINALIS (UNII: 4004498D06)
  • TURMERIC (UNII: 856YO1Z64F)
  • .DELTA.-DECALACTONE (UNII: CNA0S5T234)
  • ETHYL BUTYRATE (UNII: UFD2LZ005D)
  • .GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
  • .GAMMA.-OCTALACTONE (UNII: UHD6M52X0K)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PIPERONAL (UNII: KE109YAK00)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • ISODODECANE (UNII: A8289P68Y2)
  • JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)
  • JUNIPERUS DEPPEANA WOOD OIL (UNII: 4739QA5686)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • AZADIRACHTA INDICA FLOWER (UNII: 3TE8A92UPM)
  • AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
  • METHYL ANTHRANILATE (UNII: 981I0C1E5W)
  • METHYL BENZOATE (UNII: 6618K1VJ9T)
  • METHYLBENZYL ACETATE (UNII: P4RVP859F5)
  • MIMOSA TENUIFLORA BARK (UNII: 515MQE449I)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • NEROLIDOL (UNII: QR6IP857S6)
  • OCIMUM BASILICUM FLOWERING TOP (UNII: 7SAB275FP2)
  • HOLY BASIL LEAF (UNII: SCJ765569P)
  • PHENYLETHYL ALCOHOL (UNII: ML9LGA7468)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)
  • SODIUM ACRYLATE/STYRENE SULFONATE COPOLYMER (11000 MW) (UNII: N30934870L)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)
  • EGGPLANT (UNII: W5K7RAS4VK)
  • COCOA (UNII: D9108TZ9KG)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • VANILLIN (UNII: CHI530446X)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)

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 Refreshing Water Cream Spf 50 Product Label Images

Coola Full Spectrum 360 Refreshing Water Cream Spf 50 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 3.0%, Homosalate 5.0%, Octisalate 3.0%, Octocrylene 5.0%

Otc - Purpose

PurposeSuncreen

Indications & Usage

  • Useshelps 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

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

Otc - Stop Use

Stop use and ask doctor if skin rash occurs

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.

Dosage & Administration

Directions• apply liberally 15 minutes before sun exposure • reapply: ● after swimming or sweating● immediately after towel drying  ● at least every 2 hours● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. Todecrease this risk, regularly use a sunscreen with a broad spection SPF of 15 or higher and other sun protectionmeasures including: ● limit time in the sun, especially from: 10 a.m. - 2 p.m.● wear long-sleeve shirts, pants, hats, and sunglasses ●Children under 6 months: Ask a doctor

Inactive Ingredient

Inactive IngredientsAdipic Acid/Diglycol Crosspolymer, Aloe Barbadensis Flower Extract, Aloe Barbadensis Leaf Juice, (ORGANIC)Anisaldehyde*, Argania Spinosa Kernel Oil, Benzyl Acetate*, Bisabolol, Butylene Glycol, Caprylhydroxamic Acid,Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Citric Acid, Coccinia Indica Fruit Extract, Cocos Nucifera(Coconut) Water (ORGANIC), Corallina Officinalis Extract, Curcuma Longa (Turmeric) Root Extract, Delta-Decalactone*,Ethyl Butyrate*, Gamma-Nonalactone*, Gamma-Octalactone*, Gluconolactone, Glycerin (ORGANIC), Glyceryl Caprylate,Glyceryl Stearate, Heliotropine*, Hyaluronic Acid, Isododecane, Jasminum Sambac (Jasmine) Leaf Cell Extract, JuniperusMexicana, Lecithin, Leuconostoc/Radish Root Ferment Filtrate, Leuconostoc Ferment Filtrate, Melia Azadirachta FlowerExtract, Melia Azadirachta Leaf Extract, Methyl Anthranilate*, Methyl Benzoate*, Methyl Benzyl Acetate*, MimosaTenuiflora Bark Extract, Neopentyl Glycol Diheptanoate, Nerolidol, Ocimum Basilicum (Basil) Flower/Leaf Extract, OcimumSanctum Leaf Extract, Phenethyl Alcohol*, Propanediol, Schinus Molle Extract, Sodium Acrylates Copolymer, SodiumBenzoate, Sodium Hydroxide, Sodium Stearoyl Glutamate, Solanum Melongena (Eggplant) Fruit Extract, TheobromaCacao (Cocoa) Seed Extract, Tocopheryl Acetate, Triethyl Citrate*, Vanillin, Water, Xanthan Gum

Other Safety Information

  • Other informationprotect this product from excessive heat and direct sun

Otc - Questions

Questions or comments?Call 760-940-2125

Coola Label

SPF 5070%+OrganicCOOLA​®Refreshing Water CreamSunscreen1.5 FL OZ / 44 mLBroad Spectrum SPF 70Water Resistant (80 Minutes)5.0 FL OZ / 148 mL©2021 COOLA. Distributed by: COOLA LLC, located inSunny & Cool San Diego, CA 92010.  All Rights Reserved.†Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free*Plant-derived scent constituent. See coola.com for additional detail.CartonBottleres

* Please review the disclaimer below.