NDC 76398-008 Tom Ford Flawless Glow Foundation Broad Spectrum Spf 30

Octinoxate, Titanium Dioxide, And Zinc Oxide

NDC Product Code 76398-008

NDC Code: 76398-008

Proprietary Name: Tom Ford Flawless Glow Foundation Broad Spectrum Spf 30 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
    • 76398-008 - Tom Ford Flawless Glow Foundation Broad Spectrum Spf 30

NDC 76398-008-01

Package Description: 1 BOTTLE in 1 CARTON > 30 mL in 1 BOTTLE

NDC Product Information

Tom Ford Flawless Glow Foundation Broad Spectrum Spf 30 with NDC 76398-008 is a a human over the counter drug product labeled by Tom Ford Beauty Dist. The generic name of Tom Ford Flawless Glow Foundation Broad Spectrum Spf 30 is octinoxate, titanium dioxide, and zinc oxide. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Tom Ford Beauty Dist

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 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 Flawless Glow Foundation Broad Spectrum Spf 30 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 .056 g/100mL
  • TITANIUM DIOXIDE .035 g/100mL
  • ZINC OXIDE .024 g/100mL

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)
  • METHYL TRIMETHICONE (UNII: S73ZQI0GXM)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • ETHYLHEXYL PALMITATE (UNII: 2865993309)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • CAFFEINE (UNII: 3G6A5W338E)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
  • CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)
  • SODIUM LACTATE (UNII: TU7HW0W0QT)
  • SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • ZINC STEARATE (UNII: H92E6QA4FV)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • LAURETH-7 (UNII: Z95S6G8201)
  • WATERMELON (UNII: 231473QB6R)
  • LENTIL (UNII: 6O38V6B52O)
  • SOYBEAN (UNII: L7HT8F1ZOD)
  • APPLE (UNII: B423VGH5S9)
  • TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • HEXYLENE GLYCOL (UNII: KEH0A3F75J)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • DIPROPYLENE GLYCOL (UNII: E107L85C40)
  • MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)
  • SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM BENZOATE (UNII: OJ245FE5EU)
  • SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MICA (UNII: V8A1AW0880)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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: 02-15-2019 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 Flawless Glow Foundation Broad Spectrum Spf 30 Product Label Images

Tom Ford Flawless Glow Foundation Broad Spectrum Spf 30 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

Otc - Purpose

Active IngredientsPurposeOctinoxate 5.0%SunscreenTitanium Dioxide 3.1%SunscreenZinc Oxide 2.2%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 and evenly 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 • methyl trimethicone • phenyl trimethicone • silica • butyloctyl salicylate • dimethicone • neopentyl glycol diheptanoate • c12-15 alkyl benzoate • butylene glycol • lauryl peg-9 polydimethylsiloxyethyl dimethicone • ethylhexyl palmitate • glycerin • trimethylsiloxysilicate/dimethiconol crosspolymer • polysilicone-11 • sapindus mukorossi fruit extract • caffeine • lavandula angustifolia (lavender) oil • thermus thermophillus ferment • caesalpinia spinosa gum • morinda citrifolia fruit extract • sodium hyaluronate • dimethicone/peg-10/15 crosspolymer • peg-10 dimethicone • sodium lactate • sodium pca • polyglutamic acid • lecithin • litchi chinensis seed extract • laminaria saccharina extract • methicone • triethyl citrate • tocopheryl acetate • zinc stearate • caprylyl glycol • trimethylsiloxysilicate • disteardimonium hectorite • laureth-7 • citrullus vulgaris (watermelon) fruit extract • lens esculenta (lentil) fruit extract • glycine soja (soybean) protein • pyrus malus (apple) fruit extract • tetrahexyldecyl ascorbate • triethoxycaprylylsilane • hexylene glycol • xanthan gum • calcium chloride • sodium chloride • dipropylene glycol • dextrin • dimethicone silylate • magnesium aluminum silicate • linalool • silica dimethyl silylate • sodium citrate • disodium edta • bht • potassium sorbate • sodium benzoate • sodium dehydroacetate • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499)]

Other Information

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

* Please review the disclaimer below.

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