NDC 58414-0020 Neostrata Sheer Hydration Sunscreen Broad Spectrum Spf 40

Octinoxate, Octisalate, And Avobenzone

NDC Product Code 58414-0020

NDC Code: 58414-0020

Proprietary Name: Neostrata Sheer Hydration Sunscreen Broad Spectrum Spf 40 Additional informationCallout TooltipWhat 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: Octinoxate, Octisalate, And Avobenzone Additional informationCallout TooltipWhat 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.


Code Structure
  • 58414 - Neostrata Company Inc.
    • 58414-0020 - Neostrata Sheer Hydration

NDC 58414-0020-1

Package Description: 1 BOTTLE, PUMP in 1 CARTON > 50 mL in 1 BOTTLE, PUMP

NDC Product Information

Neostrata Sheer Hydration Sunscreen Broad Spectrum Spf 40 with NDC 58414-0020 is a a human over the counter drug product labeled by Neostrata Company Inc.. The generic name of Neostrata Sheer Hydration Sunscreen Broad Spectrum Spf 40 is octinoxate, octisalate, and avobenzone. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Neostrata Company Inc.

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 Additional informationCallout TooltipWhat 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.


Neostrata Sheer Hydration Sunscreen Broad Spectrum Spf 40 Active Ingredient(s)

Additional informationCallout TooltipWhat is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • OCTINOXATE 75 mg/mL
  • OCTISALATE 50 mg/mL
  • AVOBENZONE 30 mg/mL

Inactive Ingredient(s)

Additional informationCallout TooltipAbout 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)
  • N-ACETYLGLUCOSAMINE (UNII: V956696549)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • PEG-100 STEARATE (UNII: YD01N1999R)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • AZADIRACHTA INDICA LEAF (UNII: HKY915780T)
  • ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3)
  • VITIS VINIFERA SEED (UNII: C34U15ICXA)
  • HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • PEG-75 STEARATE (UNII: OT38R0N74H)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • EDETATE DISODIUM (UNII: 7FLD91C86K)
  • CETETH-20 (UNII: I835H2IHHX)
  • STEARETH-20 (UNII: L0Q8IK9E08)
  • AMMONIA (UNII: 5138Q19F1X)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • SODIUM BISULFITE (UNII: TZX5469Z6I)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • DIMETHICONE/DIENE DIMETHICONE CROSSPOLYMER (UNII: RSA9I561OK)

Administration Route(s)

Additional informationCallout TooltipWhat 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

Additional informationCallout TooltipWhat is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Neostrata Company Inc.
Labeler Code: 58414
FDA Application Number: part352 Additional informationCallout TooltipWhat 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. Additional informationCallout TooltipWhat 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: 02-01-2019 Additional informationCallout TooltipWhat 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: 12-31-2019 Additional informationCallout TooltipWhat 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 Additional informationCallout TooltipWhat 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.

Neostrata Sheer Hydration Sunscreen Broad Spectrum Spf 40 Product Label Images

Neostrata Sheer Hydration Sunscreen Broad Spectrum 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

Other

Drug Facts

Active Ingredients (W/W)

Avobenzone 3%, Octinoxate 7.5%, Octisalate 5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburnBroad Spectrum SPF 40If 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 - Stop Use

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 exposureUse a water resistant sunscreen if swimming or sweatingReapply sunscreen at least every 2 hoursSun 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 sunglassesChildren under 6 months: Ask a doctor

Other Information

  • Store at 15°C-30°C (59°F-86°F)Protect this product from excessive heat and direct sun

Inactive Ingredients

Aqua/Water/Eau, Acetyl Glucosamine, Butyloctyl Salicylate, Cyclopentasiloxane, Dimethicone, C12-15 Alkyl Benzoate, Glycerin, Butylene Glycol, Glyceryl Stearate, Octyldodecyl Neopentanoate, Cetyl Alcohol, PEG-100 Stearate, Cetearyl Alcohol, Vitis Vinifera (Grape) Seed Extract, Melia Azadirachta Leaf Extract, Lecithin, Arctium Lappa Root Extract, DL-Alpha Tocopheryl Acetate, Dimethicone Crosspolymer, Propylene Glycol, PEG-75 Stearate, Steareth-20, Xanthan Gum, Ceteth-20, Ammonium Hydroxide, Carbomer, Disodium EDTA, Caprylyl Glycol, Phenoxyethanol, Chlorphenesin, Sodium Bisulfite.

Questions?

1-800-628-9904

* Please review the disclaimer below.

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