NDC 42627-438 Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla Spf 15

Octonoxate, Octisalate, Titanium Dioxide

NDC Product Code 42627-438

NDC CODE: 42627-438

Proprietary Name: Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla Spf 15 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: Octonoxate, Octisalate, Titanium Dioxide 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

  • 42627 - Kingdon Animalia, Llc Dba Hourglass Cosmetics
    • 42627-438 - Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla

NDC 42627-438-01

Package Description: 1 TUBE in 1 CARTON > 50 mL in 1 TUBE

NDC Product Information

Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla Spf 15 with NDC 42627-438 is a a human over the counter drug product labeled by Kingdon Animalia, Llc Dba Hourglass Cosmetics. The generic name of Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla Spf 15 is octonoxate, octisalate, titanium dioxide. The product's dosage form is cream and is administered via topical form.

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.

Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla Spf 15 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.


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)
  • PENTAERYTHRITYL TETRAISOSTEARATE (UNII: 9D7IK5483F)
  • CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
  • HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • CALCIUM CARBONATE (UNII: H0G9379FGK)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) (UNII: V2W71V8T0X)
  • GLYCERYL MONOBEHENATE (UNII: A626UU0W2A)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)
  • MICROCRYSTALLINE WAX (UNII: XOF597Q3KY)
  • SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)
  • GOSSYPIUM HERBACEUM WHOLE (UNII: 9DK7DJK0D6)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • ETHYL ACRYLATE (UNII: 71E6178C9T)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • LYCIUM BARBARUM FRUIT (UNII: 930626MWDL)
  • PROPYLENE CARBONATE (UNII: 8D08K3S51E)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

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: Kingdon Animalia, Llc Dba Hourglass Cosmetics
Labeler Code: 42627
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 FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. 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: 06-30-2021 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: 12-31-2022 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".

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Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla Spf 15 Product Label Images

Illusion Hyaluronic Skin Tint Oil Free Sunscreen Broad Spectrum Vanilla Spf 15 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

Octinoxate  7%Octisalate 4%Titanium Dioxide 4%

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 ask a doctor if rash occurs

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 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 measure includinglimit 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

Inactive Ingredients

Water, Pentaerythrityl Tetraisostearate, Cyclopentasiloxane, Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Calcium Carbonate, Glycerin, Cetyl PEG/PPG-10/1 Dimethicone, Glyceryl Behenate, Hexyl Laurate, Polyglyceryl-4 Isostearate, Polyglyceryl-3 Polyricinoleate, Microcrystalline Wax, Synthetic Beeswax, Gossypium Herbaceum (Cotton), PEG-10 Dimethicone, Magnesium Sulfate, Sodium Chloride, Quaternium-90 Bentonite, Dimethicone, Phenoxyethanol, Polyethylacrylate, Stearic Acid, Ethylhexylglycerin, Alumina, Sodium Benzoate, Lycium Barbarum Fruit Extract, Propylene Carbonate, Potassium Sorbate, Silica Dimethyl Silylate, Silica, Triethoxycaprylylsilane, Butylene Glycol, BHT, Sodium Hyaluronate.May Contain (+/-): Mica (CI 77019), Iron Oxide Yellow (CI 77492), Red Iron Oxide (CI 77491), Black Iron Oxides

Other Information

Protect this product from excessive heat and direct sun

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