NDC 76398-007 Tom Ford Soleil Glow Tone Up Foundation Broad Spectrum Spf 45

Octinoxate, Titanium Dioxide, And Zinc Oxide

NDC Product Code 76398-007

NDC Code: 76398-007

Proprietary Name: Tom Ford Soleil Glow Tone Up Foundation Broad Spectrum Spf 45 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, Titanium Dioxide, And 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
  • 76398 - Tom Ford Beauty Dist
    • 76398-007 - Tom Ford Soleil Glow Tone Up Foundation Broad Spectrum Spf 45

NDC 76398-007-01

Package Description: 1 JAR in 1 CARTON > 12 g in 1 JAR

NDC Product Information

Tom Ford Soleil Glow Tone Up Foundation Broad Spectrum Spf 45 with NDC 76398-007 is a a human over the counter drug product labeled by Tom Ford Beauty Dist. The generic name of Tom Ford Soleil Glow Tone Up Foundation Broad Spectrum Spf 45 is octinoxate, titanium dioxide, and zinc oxide. The product's dosage form is cream and is administered via topical form.

Labeler Name: Tom Ford Beauty Dist

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.


Tom Ford Soleil Glow Tone Up Foundation Broad Spectrum Spf 45 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 4 g/100g
  • TITANIUM DIOXIDE 6.1 g/100g
  • ZINC OXIDE 3.8 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.

  • WATER (UNII: 059QF0KO0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
  • METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
  • DIETHYLHEXYL SUCCINATE (UNII: 69W9UMG3P8)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • LAURETH-4 (UNII: 6HQ855798J)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
  • DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE (UNII: D21K655H52)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LENTIL (UNII: 6O38V6B52O)
  • APPLE (UNII: B423VGH5S9)
  • THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
  • WATERMELON (UNII: 231473QB6R)
  • WHEY (UNII: 8617Z5FMF6)
  • CHLORELLA VULGARIS (UNII: RYQ4R60M02)
  • ERGOTHIONEINE (UNII: BDZ3DQM98W)
  • PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
  • ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • SUCROSE (UNII: C151H8M554)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • CAFFEINE (UNII: 3G6A5W338E)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • SOYBEAN (UNII: L7HT8F1ZOD)
  • CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
  • STANNIC OXIDE (UNII: KM7N50LOS6)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • ALUMINUM OXIDE (UNII: LMI26O6933)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)
  • BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)

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: Tom Ford Beauty Dist
Labeler Code: 76398
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: 02-10-2019 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.

Tom Ford Soleil Glow Tone Up Foundation Broad Spectrum Spf 45 Product Label Images

Tom Ford Soleil Glow Tone Up Foundation Broad Spectrum Spf 45 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

Octinoxate 4.0%Titanium Dioxide 6.1%Zinc Oxide 3.8%

Purpose

Sunscreen

Use

Helps prevent sunburn

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

  • For sunscreen use:apply liberally 15 minutes before sun exposurereapply at least every two hoursuse a water resistant sunscreen if swimming or sweatingSun 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 measures including:limit time in the sun, especially from 10 a.m. – 2 p.m.wear long-sleeved shirts, pants, hats and sunglasseschildren under 6 months of age: ask a doctor

Inactive Ingredients

Water\aqua\eau • dimethicone • octyldodecyl neopentanoate • butyloctyl salicylate • isononyl isononanoate • methyl trimethicone • diethylhexyl succinate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • laureth-4 • cetyl peg/ppg-10/1 dimethicone • butylene glycol • magnesium sulfate • dipentaerythrityl tri-polyhydroxystearate • sigesbeckia orientalis (st. paul's wort) extract • glycerin • lens esculenta (lentil) fruit extract • pyrus malus (apple) fruit extract • thermus thermophillus ferment • algae extract • citrullus vulgaris (watermelon) fruit extract • narcissus tazetta bulb extract • saccharomyces lysate extract • laminaria digitata extract • morinda citrifolia fruit extract • whey protein\lactis protein\proteine du petit-lait • chlorella vulgaris extract • ergothioneine • palmitoyl hexapeptide-12 • polygonum cuspidatum root extract • sapindus mukorossi fruit extract • pearl powder • acetyl hexapeptide-8 • lavandula angustifolia (lavender) oil • dimethicone silylate • tocopheryl acetate • dimethicone/peg-10/15 crosspolymer • sucrose • hydrolyzed wheat protein/pvp crosspolymer • caprylyl glycol • caffeine • glyceryl polymethacrylate • triethoxycaprylylsilane • methicone • dimethicone crosspolymer-3 • sodium hyaluronate • tetrahexyldecyl ascorbate • disteardimonium hectorite • peg-8 • sodium lactate • dipropylene glycol • sodium pca • glycine soja (soybean) protein • artemia extract • caesalpinia spinosa gum • tin oxide • silica • calcium chloride • alumina • disodium edta • linalool • potassium sorbate • phenoxyethanol • [+/- mica • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499) • bismuth oxychloride (ci 77163) • titanium dioxide (ci 77891)]

Other Information

Protect the product in this container from excessive heat and direct sun

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