NDC 79753-015 Coola Classic Body Sunscreen Spf 70 - Peach Blossom

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 79753-015

NDC CODE: 79753-015

Proprietary Name: Coola Classic Body Sunscreen Spf 70 - Peach Blossom 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
    • 79753-015 - Coola Classic Body Sunscreen Spf 70 - Peach Blossom

NDC 79753-015-01

Package Description: 1 TUBE in 1 CARTON > 148 mL in 1 TUBE

NDC Product Information

Coola Classic Body Sunscreen Spf 70 - Peach Blossom with NDC 79753-015 is a a human over the counter drug product labeled by Coola Llc. The generic name of Coola Classic Body Sunscreen Spf 70 - Peach Blossom 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 Classic Body Sunscreen Spf 70 - Peach Blossom 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 4.9 g/100mL
  • OCTOCRYLENE 7.5 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)
  • BUTYL ACRYLATE/C16-C20 ALKYL METHACRYLATE/METHACRYLIC ACID/METHYL METHACRYLATE COPOLYMER (UNII: 7K68DGG29P)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • CAMELINA SATIVA SEED OIL (UNII: 12824X01L0)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)
  • SAFFLOWER OIL (UNII: 65UEH262IS)
  • CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • DECANAL (UNII: 31Z90Q7KQJ)
  • 2,6-DIMETHYL-5-HEPTENAL (UNII: Z331YX9EL9)
  • ETHYL ACETOACETATE (UNII: IZP61H3TB1)
  • ETHYL BUTYRATE (UNII: UFD2LZ005D)
  • ETHYL CAPROATE (UNII: FLO6YR1SHT)
  • .GAMMA.-NONALACTONE (UNII: I1XGH66S8P)
  • .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)
  • GLUCONOLACTONE (UNII: WQ29KQ9POT)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HEXENYL ACETATE, (2Z)- (UNII: PT792BQ57D)
  • HEXYL ACETATE (UNII: 7U7KU3MWT0)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • ISOAMYL ACETATE (UNII: Z135787824)
  • MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
  • MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L)
  • OPUNTIA FICUS-INDICA LEAF (UNII: 5VM709H93V)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
  • PRUNUS PERSICA FLOWER (UNII: 19GWB0JENH)
  • 4-(P-HYDROXYPHENYL)-2-BUTANONE (UNII: 7QY1MH15BG)
  • RASPBERRY SEED OIL (UNII: 9S8867952A)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • 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 Classic Body Sunscreen Spf 70 - Peach Blossom Product Label Images

Coola Classic Body Sunscreen Spf 70 - Peach Blossom 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 4.9%, Octocrylene 7.5%

Otc - Purpose

PurposeSuncreen

Indications & Usage

  • Useshelps 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 onlyDo not use on damaged or broken skinWhen using this product keep out of eyes.Rinse with water to remove.Do not use on damaged or broken skin

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, getmedical help or contact a 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 hoursSun Protection Measures. Spending time in the sunincreases your risk of skin cancer and early skin aging. Todecrease this risk, regularly use a sunscreen with a broadspection 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 Ingredients1,2-Hexanediol, Acrylates/C12-22 Alkyl Methacrylate Copolymer, Aloe Barbadensis Leaf Juice (ORGANIC), Benzyl Alcohol, Bisabolol (ORGANIC), Brassica Campestris (Rapeseed) Seed Oil, Butyloctyl Salicylate, Camelina Sativa Seed Oil, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes (ORGANIC), Carthamus Tinctorius (Safflower) Seed Oil (ORGANIC), Citric Acid, Cocos Nucifera (Coconut) Oil*, Decanal*, Dimethyl Heptenal*, Ethyl Acetoacetate*, Ethyl Butyrate*, Ethyl Caproate*, Gamma-Nonalactone*, Gamma Undecalactone*, Gluconolactone, Glycerin (ORGANIC), Hexenyl Acetate*, Hexyl Acetate*, Hydroxyacetophenone, Isoamyl Acetate*, Limnanthes Alba (Meadowfoam) Seed Oil, Mauritia Flexuosa (Buriti) Fruit Oil, Opuntia Ficus-Indica Flower Extract, Pentylene Glycol, Polyacrylate Crosspolymer-6, Prunus Persica (Peach) Flower Extract, Raspberry Ketone*, Rubus Idaeus (Raspberry) Seed Oil, Sodium Benzoate, Sodium Hydroxide, Sodium Phytate, Triethyl Citrate*, 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 7070%+OrganicCOOLA​®ClassicBody SunscreenPeach BlossomUltra LightweightHydrates & Nourishes+Plant Protection®Broad 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.