NDC 81100-001 Hyaluronic Acid Watery Sun Gel

Octisalate, Homosalate

NDC Product Code 81100-001

NDC 81100-001-02

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE (81100-001-01)

NDC Product Information

Hyaluronic Acid Watery Sun Gel with NDC 81100-001 is a a human over the counter drug product labeled by Isntree. The generic name of Hyaluronic Acid Watery Sun Gel is octisalate, homosalate. The product's dosage form is gel and is administered via topical form.

Labeler Name: Isntree

Dosage Form: Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.

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.

Hyaluronic Acid Watery Sun Gel 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.

  • HOMOSALATE 40 mg/mL
  • OCTISALATE 40 mg/mL

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.

  • NIACINAMIDE (UNII: 25X51I8RD4)
  • BEMOTRIZINOL (UNII: PWZ1720CBH)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • BISOCTRIZOLE (UNII: 8NT850T0YS)
  • POLYSILICONE-15 (UNII: F8DRP5BB29)
  • DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE (UNII: ANQ870JD20)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • CETETH-10 (UNII: LF9X1PN3XJ)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ADENOSINE (UNII: K72T3FS567)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CENTELLA ASIATICA WHOLE (UNII: 7M867G6T1U)
  • PURSLANE (UNII: M6S840WXG5)
  • HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • OLIVE OIL (UNII: 6UYK2W1W1E)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • FIG (UNII: TGD87RII2U)
  • ASTAXANTHIN (UNII: 8XPW32PR7I)
  • MARITIME PINE (UNII: 50JZ5Z98QY)
  • SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • DIBUTYL ADIPATE (UNII: F4K100DXP3)

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: Isntree
Labeler Code: 81100
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: 12-26-2020 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: 12-31-2021 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.

Hyaluronic Acid Watery Sun Gel Product Label Images

Hyaluronic Acid Watery Sun Gel 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

Homosalate 4%


Octisalate 4%

Otc - Purpose

Helps 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.

Indications & Usage

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.

Dosage & Administration

Apply liberally 15 minutes before sun exposure. Reapply at least every two hours.

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, CENTELLA ASIATICA LEAF WATER, ISONONYL WATER, BUTYLENE GLYCOL, DIBUTYL ADIPATE, NIACINAMIDE, BIS-ETHYLHEXYLOXYPHENOL METHOXYPHENYL TRIAZINE, CYCLOPENTASILOXANE, METHYLENE BIS-BENZOTRIAZOLYL TETRAMETHYLBUTYLPHENOL, POLYSILICONE-15, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATE, 1,2-HEXANEDIOL, PENTYLENE GLYCOL, CETETH-10, TROMETHAMINE, DECYL GLUCOSIDE, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, CARBOMER, CETYL PEG/PPG-10/1 DIMETHICONE, SODIUM HYALURONATE, PROPANEDIOL, ETHYLHEXYLGLYCERIN, ADENOSINE, PROPYLENE GLYCOL, XANTHAN GUM, CENTELLA ASIATICA EXTRACT, PORTULACA OLERACEA EXTRACT, HOUTTUYNIA CORDATA EXTRACT, GLYCERIN, OLEA EUROPAEA (OLIVE) FRUIT OIL, TOCOPHEROL, HYDROGENATED LECITHIN, FICUS CARICA (FIG) FRUIT EXTRACT, CERAMIDE NP, ASTAXANTHIN, PINUS PINASTER BARK EXTRACT, SODIUM ACETYLATED HYALURONATE, SODIUM HYALURONATE CROSSPOLYMER, ASCORBYL PROPYL HYALURONATE, HYDROXYPROPYLTRIMONIUM HYALURONATE, HYDROLYZED SODIUM HYALURONATE, HYDROLYZED HYALURONIC ACID, HYALURONIC ACID

* Please review the disclaimer below.