NDC 75936-302 Shimmershade Broad Spectrum Sunscreen Spf 30 Golden Hour

Octisalate, Zinc Oxide

NDC Product Code 75936-302

NDC Code: 75936-302

Proprietary Name: Shimmershade Broad Spectrum Sunscreen Spf 30 Golden Hour 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: Octisalate, Zinc Oxide 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
  • 75936 - Taylor James Ltd
    • 75936-302 - Shimmershade Broad Spectrum Sunscreen Spf 30 Golden Hour

NDC 75936-302-01

Package Description: 5 g in 1 JAR

NDC Product Information

Shimmershade Broad Spectrum Sunscreen Spf 30 Golden Hour with NDC 75936-302 is a a human over the counter drug product labeled by Taylor James Ltd. The generic name of Shimmershade Broad Spectrum Sunscreen Spf 30 Golden Hour is octisalate, zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Taylor James Ltd

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 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.


Shimmershade Broad Spectrum Sunscreen Spf 30 Golden Hour 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.

  • OCTISALATE 5 g/100g
  • ZINC OXIDE 20 g/100g

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.

  • TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • MICA (UNII: V8A1AW0880)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ISODODECANE (UNII: A8289P68Y2)
  • CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • TRIMETHYLSILOXYSILICATE (M/Q 0.8-1.0) (UNII: 25LXE464L2)
  • VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
  • .DELTA.-TOCOPHEROL (UNII: JU84X1II0N)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
  • POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • MICA (UNII: V8A1AW0880)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)
  • HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
  • ISODODECANE (UNII: A8289P68Y2)
  • CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)

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: Taylor James Ltd
Labeler Code: 75936
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 01-24-2019 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: 12-31-2020 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.

Shimmershade Broad Spectrum Sunscreen Spf 30 Golden Hour Product Label Images

Shimmershade Broad Spectrum Sunscreen Spf 30 Golden Hour 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

Active Ingredients PurposeOctisalate 5% SunscreenZinc Oxide 20% Sunscreen

Otc - Purpose

  • UsesHelps 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

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.

Indications & Usage

Stop use and ask a doctor if rash occurs.

Warnings

WarningsFor external use onlyDo not use on damaged or broken skin.
When using this product keep out of eyes. Rinse with water to remove.

Dosage & Administration

Directionsapply generously and evenly 15 minutes before sun exposure

reapply 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 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

Inactive IngredientsIsododecane, Mica, Titanium Dioxide, Polymethylsilsesquioxane/Silica Crosspolymer, Polyethylene,

Caprylyl Methicone, Iron oxides, C18-38 Alkyl Hydroxystearoyl Stearate, Polyhydroxystearic Acid,

Dimethicone, Trimethylsiloxysilicate, Silica, VP/Eicosene Copolymer, Polyglyceryl-3 Polyricinoleate,

Polyglyceryl-3 Diisostearate,Triethoxycaprylylsilane, Norbornene/tris(trimethylsiloxy)silyl-norbornene

Copolymer, Tin Oxide, Helianthuus Annuus (Sunflower) Seed Oil, Jasminum Officinale (Jasmine) Flower

Extract, Rose Extract, Tocopherol.

* Please review the disclaimer below.

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