NDC 75936-354 Defense Refresh (re)setting Mist Spf 40

Avobenzone, Homosalate , Octisalate, Octocrylene

NDC Product Code 75936-354

NDC CODE: 75936-354

Proprietary Name: Defense Refresh (re)setting Mist Spf 40 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

  • 75936 - Taylor James, Llc
    • 75936-354 - Defense Refresh (re)setting Mist Spf 40

NDC 75936-354-01

Package Description: 30 mL in 1 BOTTLE, SPRAY

NDC Product Information

Defense Refresh (re)setting Mist Spf 40 with NDC 75936-354 is a a human over the counter drug product labeled by Taylor James, Llc. The generic name of Defense Refresh (re)setting Mist Spf 40 is avobenzone, homosalate , octisalate, octocrylene. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Taylor James, Llc

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.

Defense Refresh (re)setting Mist Spf 40 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 9.8 g/100mL
  • AVOBENZONE 2.9 g/100mL
  • OCTISALATE 4.9 g/100mL
  • OCTOCRYLENE 9.5 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.

  • ALCOHOL (UNII: 3K9958V90M)
  • NYLON-12 (UNII: 446U8J075B)

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: Taylor James, Llc
Labeler Code: 75936
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: 01-20-2021 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’.

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Defense Refresh (re)setting Mist Spf 40 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

Avobenzone 2.9%..............SunscreenHomosalate 9.8%.............SunscreenOctisalate 4.9%..................SunscreenOctocrylene 9.5%...............Sunscreen

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

Otc - Keep Out Of Reach Of Children

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

Indications & Usage

Stop use and ask a doctor if rash occurs.


For external use only. Do not useon damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.

Dosage & Administration

· Shake well then apply generously and evenly 15 minutes before sun exposure.· reapply:· after 40 minutes of swimming or sweating· immediately after towel drying· at least every 2 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 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: Ask a doctor

Inactive Ingredient

Alcohol Denat., Bisabolol, Brassica Campestris/Aleurites Fordi Oil Copolymer, Butyloctyl Salicylate, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Dicaprylyl Carbonate, Diethylhexyl Syringylidenemalonate, Diheptyl Succinate, Diisooctyl Succinate, Ethyl Ferulate, Isododecane, Lauroyl Lysine, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Nylon-12, PVP, Rosmarinus Officinalis (Rosemary) Leaf Oil, Silica Caprylyl Silylate

Other Safety Information

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

* Please review the disclaimer below.