NDC 71070-868 Jacket Spf-50 Broad Spectrum Sunscreen

Zinc Oxide, Homosalate, Octisalate, Octocrylene

NDC Product Code 71070-868

NDC Code: 71070-868

Proprietary Name: Jacket Spf-50 Broad Spectrum 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: Zinc Oxide, 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.


Code Structure
  • 71070 - Balshi Md Dermaceuticals
    • 71070-868 - Jacket Spf-50 Broad Spectrum Sunscreen

NDC 71070-868-04

Package Description: 120 mL in 1 TUBE

NDC Product Information

Jacket Spf-50 Broad Spectrum Sunscreen with NDC 71070-868 is a a human over the counter drug product labeled by Balshi Md Dermaceuticals. The generic name of Jacket Spf-50 Broad Spectrum Sunscreen is zinc oxide, homosalate, octisalate, octocrylene. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Balshi Md Dermaceuticals

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.


Jacket Spf-50 Broad Spectrum 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.

  • ZINC OXIDE 60 mg/mL
  • HOMOSALATE 100 mg/mL
  • OCTISALATE 50 mg/mL
  • OCTOCRYLENE 50 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.

  • BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
  • ALLANTOIN (UNII: 344S277G0Z)
  • ALOE VERA LEAF (UNII: ZY81Z83H0X)
  • WATER (UNII: 059QF0KO0R)
  • ASCORBIC ACID (UNII: PQ6CK8PD0R)
  • GREEN TEA LEAF (UNII: W2ZU1RY8B0)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • CETEARYL OLIVATE (UNII: 58B69Q84JO)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CUCUMBER (UNII: YY7C30VXJT)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • CYCLOMETHICONE 4 (UNII: CZ227117JE)
  • CYMBOPOGON CITRATUS LEAF (UNII: 06JMS448M5)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • LICORICE (UNII: 61ZBX54883)
  • HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • POMEGRANATE (UNII: 56687D1Z4D)
  • SORBITAN OLIVATE (UNII: MDL271E3GR)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)
  • CORN (UNII: 0N8672707O)
  • PROPANEDIOL (UNII: 5965N8W85T)

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: Balshi Md Dermaceuticals
Labeler Code: 71070
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: 04-15-2019 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.

Jacket Spf-50 Broad Spectrum Sunscreen Product Label Images

Jacket Spf-50 Broad Spectrum 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

Zinc Oxide 6.00%Homosalate 10.00%Octisalate 5.00%Octocrylene 5.00%

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.

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 2 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 -2pm *Wear long sleeve shirts, pants, hats and sunglasses *For children under 6 months, consult a physician.

Other Ingredients

Acrylates Copolymer, Allantoin, Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), a-Arbutin, Ascorbic Acid (Vitamin C), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Ceteareth 20, Cetearyl Olivate, Cetyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Cymbopogon Schoenanthus (Lemongrass) Oil, Dimethicone, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Root Extract, Helianthus Annuus (Sunflower) Oil, Magnesium Aluminum Silicate, Phenoxyethanol, Polysorbate 20, Punica Granatum (Pomegranate) Extract, Sorbitan Olivate, Stearyl Alcohol, Tocopheryl Acetate (Vitamin E), Tridecyl Salicylate, Zema (Corn) Propanediol

Other Information

Protect this product from excessive heat and direct sunlight.

* Please review the disclaimer below.

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