NDC 0363-0940 Walgreens Broad Spectrum Spf 30 Dry Touch Sunscreen

Avobenzone, Homosalate, Octinoxate, Octisalate, Oxybenzone

NDC Product Code 0363-0940

NDC CODE: 0363-0940

Proprietary Name: Walgreens Broad Spectrum Spf 30 Dry Touch Sunscreen 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, Octinoxate, Octisalate, Oxybenzone 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

  • 0363 - Walgreen Company
    • 0363-0940 - Walgreens Broad Spectrum Spf 30 Dry Touch Sunscreen

NDC 0363-0940-66

Package Description: 100 mL in 1 TUBE

NDC Product Information

Walgreens Broad Spectrum Spf 30 Dry Touch Sunscreen with NDC 0363-0940 is a a human over the counter drug product labeled by Walgreen Company. The generic name of Walgreens Broad Spectrum Spf 30 Dry Touch Sunscreen is avobenzone, homosalate, octinoxate, octisalate, oxybenzone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Walgreen Company

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.

Walgreens Broad Spectrum Spf 30 Dry Touch Sunscreen 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.

  • AVOBENZONE 20 mg/mL
  • HOMOSALATE 70 mg/mL
  • OCTINOXATE 75 mg/mL
  • OCTISALATE 50 mg/mL
  • OXYBENZONE 30 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.

  • WATER (UNII: 059QF0KO0R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
  • HEXADECYL POVIDONE (UNII: AG75W62QYU)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)
  • OAT (UNII: Z6J799EAJK)
  • SQUALANE (UNII: GW89575KF9)
  • ASCORBYL PALMITATE (UNII: QN83US2B0N)
  • VITAMIN A (UNII: 81G40H8B0T)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • CETYL DIMETHICONE 45 (UNII: IK315POC44)
  • LEVOMENOL (UNII: 24WE03BX2T)
  • GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • POLYSORBATE 60 (UNII: CAL22UVI4M)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • BENZYL ALCOHOL (UNII: LKG8494WBH)
  • ISOPROPYLPARABEN (UNII: A6EOX47QK0)
  • ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
  • BUTYLPARABEN (UNII: 3QPI1U3FV8)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)

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: Walgreen Company
Labeler Code: 0363
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: 11-12-2015 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 - 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.

Walgreens Broad Spectrum Spf 30 Dry Touch Sunscreen Product Label Images

Walgreens Broad Spectrum Spf 30 Dry Touch Sunscreen 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

Avobnezone 2.0%, Homosalate 7.0%, Octinoxate 7.5%, Octisalate 5.0%, Oxybenzone 3.0%

Purpose

Sunscreen

Uses

  • Helps 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

For external use only

Otc - Do Not Use

Do not use • on damaged or broken skin

Otc - When Using

When using this product • keep out of eyes. Rinse with water to remove.

Otc - Ask Doctor

Stop use and ask a doctor if • 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.

Directions

  • Apply liberally 15 minutes before sun exposurereapply:    • after 80 minutes of swimming or sweating    • immediately after towel drying    • at least every 2 hours    • children under 6 months: ask a doctorSun 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 or higher and other sun protection measures including:    • limit time in the sun, especially from 10 a.m.-2 p.m.    • wear long-sleeve shirts, pants, hats, and sunglasses

Other Information

  • Protect this product from excessive heat and direct sunmay stain or damage some fabrics, materials or surfaces

Inactive Ingredients

Water, silica, adipic acid/diethylene glycol/glycerin crosspolymer, VP/hexadecene copolymer, glycerin, dimethicone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, avena sativa (oat) kernel extract, squalane, ascorbyl palmitate, retinyl palmitate, tocopheryl acetate, BHT, cetyl dimethicone bisabolol, dipotassium glycyrrhizate, glyceryl stearate, PEG-100 stearate, polysorbate 60, tetrasodium EDTA, butylene glycol, trimethylsiloxysilicate, xanthan gum, benzyl alcohol, isopropylparaben, isobutylparaben, butylparaben, phenoxyethanol, fragrance

* Please review the disclaimer below.