NDC 76398-010 Tom Ford Shade And Illuminate Soft Radiance Foundation Broad Spectrum Spf 50

Ensulizole, Octinoxate, Octisalate, And Zinc Oxide

NDC Product Code 76398-010

NDC CODE: 76398-010

Proprietary Name: Tom Ford Shade And Illuminate Soft Radiance Foundation Broad Spectrum Spf 50 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: Ensulizole, Octinoxate, Octisalate, And Zinc Oxide 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • This medication is used to treat and prevent diaper rash and other minor skin irritations (e.g., burns, cuts, scrapes). It works by forming a barrier on the skin to protect it from irritants/moisture.

NDC Code Structure

  • 76398 - Tom Ford Beauty Dist
    • 76398-010 - Tom Ford Shade And Illuminate Soft Radiance Foundation Broad Spectrum Spf 50

NDC 76398-010-01

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

NDC Product Information

Tom Ford Shade And Illuminate Soft Radiance Foundation Broad Spectrum Spf 50 with NDC 76398-010 is a a human over the counter drug product labeled by Tom Ford Beauty Dist. The generic name of Tom Ford Shade And Illuminate Soft Radiance Foundation Broad Spectrum Spf 50 is ensulizole, octinoxate, octisalate, and zinc oxide. The product's dosage form is liquid and is administered via topical form.

Labeler Name: Tom Ford Beauty Dist

Dosage Form: Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.

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.

Tom Ford Shade And Illuminate Soft Radiance Foundation Broad Spectrum Spf 50 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.

  • ENSULIZOLE .0324 g/mL
  • OCTINOXATE .0804 g/mL
  • OCTISALATE .054 g/mL
  • ZINC OXIDE .0456 g/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.

  • WATER (UNII: 059QF0KO0R)
  • DIMETHICONE (UNII: 92RU3N3Y1O)
  • PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: 25G622K2RA)
  • TROMETHAMINE (UNII: 023C2WHX2V)
  • DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)
  • HEXYL LAURATE (UNII: 4CG9F9W01Q)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • HYDROXYETHYL UREA (UNII: MBQ7DDQ7AR)
  • TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)
  • HYLOCEREUS UNDATUS FRUIT (UNII: WUG58TD53X)
  • ACAI OIL (UNII: Z0W6766A2W)
  • CARAPA GUIANENSIS SEED OIL (UNII: Y82418EH2I)
  • LAVENDER OIL (UNII: ZBP1YXW0H8)
  • SAPINDUS MUKOROSSI FRUIT (UNII: 66H9NW427Y)
  • NONI FRUIT (UNII: 7829X3G2X5)
  • POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
  • COPAIFERA OFFICINALIS RESIN (UNII: 1VH544O5AT)
  • GLYCERYL TRIOLEATE (UNII: O05EC62663)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • BETAINE (UNII: 3SCV180C9W)
  • CAFFEINE (UNII: 3G6A5W338E)
  • ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)
  • .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
  • TREHALOSE (UNII: B8WCK70T7I)
  • HYDROGENATED COCO-GLYCERIDES (UNII: XDD37N2GPR)
  • CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
  • LAURETH-7 (UNII: Z95S6G8201)
  • SODIUM CHLORIDE (UNII: 451W47IQ8X)
  • DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
  • METHICONE (20 CST) (UNII: 6777U11MKT)
  • LINOLEIC ACID (UNII: 9KJL21T0QJ)
  • LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
  • STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
  • CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
  • AMMONIUM POLYACRYLOYLDIMETHYL TAURATE (55000 MPA.S) (UNII: F01RIY4371)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
  • PALMITIC ACID (UNII: 2V16EO95H1)
  • STEARIC ACID (UNII: 4ELV7Z65AP)
  • OLEIC ACID (UNII: 2UMI9U37CP)
  • POLYSORBATE 80 (UNII: 6OZP39ZG8H)
  • POLYSORBATE 20 (UNII: 7T1F30V5YH)
  • DOCOSANOL (UNII: 9G1OE216XY)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • LINALOOL, (+/-)- (UNII: D81QY6I88E)
  • EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
  • POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
  • SODIUM DEHYDROACETATE (UNII: 8W46YN971G)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MICA (UNII: V8A1AW0880)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
  • FERROSOFERRIC OXIDE (UNII: XM0M87F357)

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

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Tom Ford Shade And Illuminate Soft Radiance Foundation Broad Spectrum Spf 50 Product Label Images

Tom Ford Shade And Illuminate Soft Radiance Foundation Broad Spectrum Spf 50 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 IngredientsPurposeEnsulizole 2.7%SunscreenOctinoxate 6.7%SunscreenOctisalate 4.5%SunscreenZinc Oxide 3.8%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 • dimethicone • phenyl trimethicone • butylene glycol • glycerin • polymethylsilsesquioxane • lauryl peg-9 polydimethylsiloxyethyl dimethicone • hdi/ppg/polycaprolactone crosspolymer • trimethylsiloxysilicate/dimethiconol crosspolymer • tromethamine • polysilicone-11 • hexyl laurate • cetyl peg/ppg-10/1 dimethicone • neopentyl glycol diheptanoate • hydroxyethyl urea • tremella fuciformis sporocarp extract • hylocereus undatus fruit extract • euterpe oleracea fruit oil • carapa guaianensis seed oil • lavandula angustifolia (lavender) oil • sapindus mukorossi fruit extract • morinda citrifolia fruit extract • polyglyceryl-4 isostearate • copaifera officinalis (balsam copaiba) resin • triolein • caprylic/capric triglyceride • betaine • caffeine • acetyl hexapeptide-8 • tocopheryl acetate • trehalose • hydrogenated coco-glycerides • caesalpinia spinosa gum • trimethylsiloxysilicate • polyhydroxystearic acid • lecithin • glyceryl stearate • triethoxycaprylylsilane • laureth-7 • sodium chloride • disteardimonium hectorite • methicone • linoleic acid • phospholipids • stearyl alcohol • cetearyl alcohol • ammonium polyacryloyldimethyl taurate • sodium hyaluronate • tocopherol • triethyl citrate • palmitic acid • dimethicone/divinyldimethicone silsesquioxane crosspolymer • phytosteryl canola glycerides • stearic acid • oleic acid • polysorbate 80 • polysorbate 20 • behenyl alcohol • silica • linalool • disodium edta • bht • potassium sorbate • 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

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