NDC 72296-050 Tula Skincare Protect Glow Daily Sunscreen Gel Broad Spectrum Spf 30

Tula Skincare Protect Glow Daily Sunscreen Gel Broad Spectrum Spf 30

NDC Product Code 72296-050

NDC CODE: 72296-050

Proprietary Name: Tula Skincare Protect Glow Daily Sunscreen Gel Broad Spectrum 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: Tula Skincare Protect Glow Daily Sunscreen Gel Broad Spectrum Spf 30 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

  • 72296 - Tula Life Llc
    • 72296-050 - Tula Skincare Protect Glow Daily Sunscreen Gel Broad Spectrum Spf 30

NDC 72296-050-50

Package Description: 1 TUBE in 1 CARTON > 50 g in 1 TUBE

NDC Product Information

Tula Skincare Protect Glow Daily Sunscreen Gel Broad Spectrum Spf 30 with NDC 72296-050 is a a human over the counter drug product labeled by Tula Life Llc. The generic name of Tula Skincare Protect Glow Daily Sunscreen Gel Broad Spectrum Spf 30 is tula skincare protect glow daily sunscreen gel broad spectrum spf 30. The product's dosage form is lotion and is administered via topical form.

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

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.

Tula Skincare Protect Glow Daily Sunscreen Gel Broad Spectrum 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.

  • WATER (UNII: 059QF0KO0R)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • PENTYLENE GLYCOL (UNII: 50C1307PZG)
  • LACTOCOCCUS LACTIS (UNII: F1A0PSN10V)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • ECTOINE (UNII: 7GXZ3858RY)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SILICON (UNII: Z4152N8IUI)
  • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
  • HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL)
  • ARGININE (UNII: 94ZLA3W45F)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • DIBUTYL LAUROYL GLUTAMIDE (UNII: 3V7K3IA58X)
  • DIBUTYL ETHYLHEXANOYL GLUTAMIDE (UNII: 0IAF2L30VS)
  • HYDROXYECTOIN (UNII: CIJ7YN252E)
  • ANANAS COMOSUS WHOLE (UNII: KVZ6B40N8U)
  • CARICA PAPAYA LEAF (UNII: 66J7636Z2I)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • LACTIC ACID (UNII: 33X04XA5AT)
  • DISODIUM EDTA-COPPER (UNII: 6V475AX06U)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
  • HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • CITRUS AURANTIUM FRUIT (UNII: DQD16J2B5O)
  • PYRUS COMMUNIS FLOWER (UNII: P6Y3X4TOIW)
  • RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)
  • VANILLA PLANIFOLIA LEAF (UNII: WER36ZQQ2R)
  • PIMPINELLA ANISUM WHOLE (UNII: HO63CL229O)

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: Tula Life Llc
Labeler Code: 72296
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 12-24-2021 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.

Tula Skincare Protect Glow Daily Sunscreen Gel Broad Spectrum Spf 30 Product Label Images

Tula Skincare Protect Glow Daily Sunscreen Gel Broad Spectrum 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

Active Ingredients

Avobenzone 3%Homosalate 10%Octisalate 5%

Uses

• 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

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 use and ask a docor if rash occurs


Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

• apply generously 15 minutes before sun exposure


• reapply at least every 2 hours


• use a water-resistant sunscreen if swimming or sweating


• 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


value 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-sleeved shirts, pants, hats, and sunglasses


• children under 6 months of age: Ask a doctor

Inactive Ingredients

Aqua/Water/Eau, Butyloctyl Salicylate, Pentylene Glycol,


Lactococcus Ferment Lysate, 1,2-Hexanediol, Silica, Ectoin,


Glycerin, Arginine, Hydroxyectoin, Ananas Sativus


(Pineapple) Fruit Extract, Carica Papaya (Papaya) Fruit


Extract, Lactic Acid, Camellia Sinensis Leaf Extract, Hedychium


Coronarium Root Extract, Triethyl Citrate, Citrus Aurantium


Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel


Extract, Pyrus Communis (Pear) Fruit Extract), Pyrus Malus


(Apple) Fruit Extract, Rubus Idaeus (Raspberry) Fruit Extract,


Vanilla Planifolia Fruit Extract, Pimpinella Anisum Fruit


Extract, Mica, Tocopherol, Ammonium Acryloyldimethyltaurate/


VP Copolymer, Synthetic Fluorphlogopite, Hydrolyzed


Wheat Protein/PVP Crosspolymer, Carbomer, Dibutyl Lauroyl


Glutamide, Dibutyl Ethylhexanoyl Glutamide, Propanediol,


Trisodium Ethylenediamine Disuccinate, Sodium Chloride,


Sodium Benzoate, Ehtylhexylglycerin, Tin Oxide,


Phenoxyethanol

Other Information

• protect the product in this container from excessive heat and direct sun

* Please review the disclaimer below.