NDC 79753-038 Coola Sun Silk Drops Spf 30

Avobenzone 3%, Octisalate 4%, Octocrytene 8%

NDC Product Code 79753-038

NDC 79753-038-01

Package Description: 1 BOTTLE in 1 CARTON > 30 mL in 1 BOTTLE

NDC Product Information

Coola Sun Silk Drops Spf 30 with NDC 79753-038 is a a human over the counter drug product labeled by Coola Llc. The generic name of Coola Sun Silk Drops Spf 30 is avobenzone 3%, octisalate 4%, octocrytene 8%. The product's dosage form is liquid and is administered via topical form.

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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 Sun Silk Drops 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.


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.

  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYGLYCERYL-6 STEARATE (UNII: ETY9Q81E2T)
  • SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERS (UNII: R2Z4507WJN)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • JOJOBA OIL (UNII: 724GKU717M)
  • COCOA (UNII: D9108TZ9KG)
  • JASMINUM SAMBAC FLOWER (UNII: 2S686I937F)
  • SCHINUS MOLLE FRUITING TOP (UNII: T8L6O1KSB4)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)
  • ARTHROSPIRA PLATENSIS (UNII: 9L3TIH1UUE)
  • WATER (UNII: 059QF0KO0R)
  • ETHYL FERULATE (UNII: 5B8915UELW)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • PHYTATE SODIUM (UNII: 88496G1ERL)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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: 09-01-2021 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 - NO 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".

* Please review the disclaimer below.

Coola Sun Silk Drops Spf 30 Product Label Images

Coola Sun Silk Drops 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 3%, Octisalate 4%, Octocrylene 8%

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 withwater 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● shake well ● apply liberally 15 minutes before sunexposure • reapply: ● after 80 minutes of swimming or sweating  ● immediately after towel drying  ● at least every 2 hours● Sun Protection Measures. Spending time in the sunincreases your risk of skin cancer and early skin aging.To decrease this risk, regularly use a sunscreen with abroad spectrum SPF of 15 or higher and other sunprotection measures 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 IngredientsAloe Barbadensis Leaf Juice (ORGANIC),Butyloctyl Salicylate, Glycerin (ORGANIC),Polyglyceryl-6 Stearate, Carthamus Tinctorius(Safflower) Seed Oil (ORGANIC), Olea Europaea(Olive) Fruit Oil (ORGANIC), Simmondsia Chinensis(Jojoba) Seed Oil (ORGANIC), Theobroma Cacao(Cocoa) Seed Extract, Jasminum Sambac(Jasmine) Leaf Cell Extract, Schinus Molle Extract,Sodium Hyaluronate, Sodium Hydroxide, PlanktonExtract, Water, Ethyl Ferulate, Propanediol,Butylene Glycol, 1,2-Hexanedipol, Caprylyl Glycol,Glyceryl Stearate, Hydroxyacetophenone,Polyglyceryl-6 Behenate, Acrylates/10-30 AlkylAcrylate Crosspolymer, Sodium Phylae,Tocopheryl Acetate, Fragrance (Natural)

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 3070%+OrganicCOOLA​®Sun Silk DropsSunscreen1.0 FL OZ / 30 mL*SPF value may decrease if blended.For detailed instructions, see insert.©2021 COOLA. Distributed by: COOLA LLC, located in Sunny & Cool San Diego, CA 92010.  All Rights Reserved.  www.coola.comCartonBottleres

* Please review the disclaimer below.