NDC 82188-222 I Know Very Necessary Broad Spectrum Spf-40 Moisturizing Cream

Avobenzone, Octisalate, Octocrylene

NDC Product Code 82188-222

NDC CODE: 82188-222

Proprietary Name: I Know Very Necessary Broad Spectrum Spf-40 Moisturizing Cream 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, 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

  • 82188 - Thirty7 Llc
    • 82188-222 - I Know Very Necessary Broad Spectrum Spf-40 Moisturizing Cream

NDC 82188-222-00

Package Description: 1 JAR in 1 CARTON > 50 mL in 1 JAR

NDC Product Information

I Know Very Necessary Broad Spectrum Spf-40 Moisturizing Cream with NDC 82188-222 is a a human over the counter drug product labeled by Thirty7 Llc. The generic name of I Know Very Necessary Broad Spectrum Spf-40 Moisturizing Cream is avobenzone, octisalate, octocrylene. 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.

I Know Very Necessary Broad Spectrum Spf-40 Moisturizing Cream 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)
  • WATER (UNII: 059QF0KO0R)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • TRICAPRILIN (UNII: 6P92858988)
  • CHAMOMILE (UNII: FGL3685T2X)
  • COCOYL CAPRYLOCAPRATE (UNII: 8D9H4QU99H)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • MANGO (UNII: I629I3NR86)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • ALMOND (UNII: 3Z252A2K9G)
  • PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • SESAME OIL UNSAPONIFIABLES (UNII: K9GA601CEG)
  • SQUALANE (UNII: GW89575KF9)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
  • GRAPE SEED OIL (UNII: 930MLC8XGG)

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: Thirty7 Llc
Labeler Code: 82188
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.

I Know Very Necessary Broad Spectrum Spf-40 Moisturizing Cream Product Label Images

I Know Very Necessary Broad Spectrum Spf-40 Moisturizing Cream 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 3.00 %


Octisalate 5.00%


Octocrylene 10.00 %

Purpose

Sunscreen

Uses:

  • Helps prevent sunburn.higher SPF gives more sunburn protectionIf 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 not intended for ingestion

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 Doctor If

  • Rash or irritation develops and lasts.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

If Pregnant Or Breast-Feeding,

Ask a health professional before use

Other Information:

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

Questions?

1-888-985-2237

Directions:

  • Apply liberally 15 minutes before sun exposureChildren under 6 months of age: ask a doctor.Reapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease therisk, regularly use a sunscreen with broad spectrum SPF 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.

Inactive Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Extract, Capric/Caprylic Triglyceride, Chamomilla Recutita (Chamomile) Extract, Coco-Caprylate/Caprate, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Hyaluronic Acid, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Macadamia Ternifolia Nut Oil, Mangifera Indica (Mango) Butter, Parfum (Fragrance),  Phenoxyethanol, Polyhydroxystearic Acid, Polysorbate-20, Prunus Amygdalus Dulcis (Almond) Oil, Punica Granatum (Pomegranate) Extract, Retinyl Palmitate (Vitamin A), Rosa Canina (Rose) Hips Oil, Rosmarinus Officinalis (Rose) Hips Oil, Sesamum Indicum (Sesame) Oil, Squalane, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Vitis Vinifera (Grape) Seed Oil

* Please review the disclaimer below.