NDC 70859-052 Nuhydrashield 30 Spf-30 Sunscreen

Octisalate, Octocrylene, Avobenzone

NDC Product Code 70859-052

NDC Code: 70859-052

Proprietary Name: Nuhydrashield 30 Spf-30 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: Octisalate, Octocrylene, Avobenzone 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

  • 70859 - Nucare Pharmaceuticals,inc.
    • 70859-052 - Nuhydrashield 30 Spf-30 Sunscreen

NDC 70859-052-01

Package Description: 120 mL in 1 TUBE

NDC Product Information

Nuhydrashield 30 Spf-30 Sunscreen with NDC 70859-052 is a a human over the counter drug product labeled by Nucare Pharmaceuticals,inc.. The generic name of Nuhydrashield 30 Spf-30 Sunscreen is octisalate, octocrylene, avobenzone. The product's dosage form is cream and is administered via topical form.

Labeler Name: Nucare Pharmaceuticals,inc.

Dosage Form: Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.

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.

Nuhydrashield 30 Spf-30 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.

  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 50 mg/mL
  • AVOBENZONE 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.

  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ARGAN OIL (UNII: 4V59G5UW9X)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
  • COCONUT OIL (UNII: Q9L0O73W7L)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CYCLOMETHICONE 4 (UNII: CZ227117JE)
  • CARROT (UNII: L56Z1JK48B)
  • HYALURONIC ACID (UNII: S270N0TRQY)
  • ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)
  • LAURETH-7 (UNII: Z95S6G8201)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POMEGRANATE (UNII: 56687D1Z4D)
  • VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
  • SACCHARIDE ISOMERATE (UNII: W8K377W98I)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
  • TROLAMINE (UNII: 9O3K93S3TK)

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: Nucare Pharmaceuticals,inc.
Labeler Code: 70859
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: 09-10-2019 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: 12-31-2020 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’.

* Please review the disclaimer below.

Nuhydrashield 30 Spf-30 Sunscreen Product Label Images

Nuhydrashield 30 Spf-30 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

Octisalate 5.00%


Octocrylene 5.00%


Avobenzone 3.00%

Purpose

Sunscreen

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 Consult Physician

  • If irritation or rash develops.

Keep Out Of Reach Of Children.

  • If product is swallowed, get medical attention or contact poison control center immediately.

Directions:

  • Apply liberally 15-minutes before sun exposure.Reapply:- At least every two-hours.
  • - Immediately after swimming, sweating or towel drying.
  • SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other
  • Sun protection measures including:
  • - Limit time in the sun, especially between 10am and 2pm.
  • - Wear long sleeve shirts, pants, hats and sunglasses.
  • - For children under 6-months, consult a physician.

Other Ingredients:

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Butyrospermum Parkii (Shea) Butter, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Glucoside, Cocos Nucifera (Coconut) Oil, Cyclopentasiloxane, Cyclotetrasiloxane, Daucus Carota Sativa (Carrot) Extract, Hyaluronic Acid, Isostearyl Palmitate, Laureth-7, Parfum (fragrance), Phenoxyethanol,


Polyacrylamide, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, Sodium PCA, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Triethanolamine.

Other Information:

  • Protect this product from excessive heat and direct sunlight.

* Please review the disclaimer below.