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Traceless touch foundation broad spectrum spf 45 refill cushion compact - Medication Information

Product NDC Code 76398-009
Drug Name

Traceless touch foundation broad spectrum spf 45 refill cushion compact

Type Brand
Active Ingredients
Titanium dioxide 7.6 g/100g
Zinc oxide 5.1 g/100g
Route TOPICAL
Dosage Form CREAM
Application Number M020
Labeler Name TOM FORD BEAUTY DIST
Packages
Package NDC Code Description
76398-009-01 1 jar in 1 carton (76398-009-01) / 12 g in 1 jar
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active ingredients Titanium Dioxide 7.6% Zinc Oxide 5.1%

Dosage and administration

Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.
Directions For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two hours use a water resistant sunscreen if swimming or sweating 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 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 of age: ask a doctor

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients water\aqua\eau • dimethicone • butyloctyl salicylate • octyldodecyl neopentanoate • butylene glycol • isononyl isononanoate • lauryl peg-9 polydimethylsiloxyethyl dimethicone • diethylhexyl succinate • phenyl trimethicone • methyl trimethicone • silica • dimethicone silylate • tocopheryl acetate • magnesium sulfate • dipentaerythrityl tri-polyhydroxystearate • porphyra yezoensis (algae) extract • silk powder\serica\poudre de soie • morinda citrifolia fruit extract • sapindus mukorossi fruit extract • litchi chinensis seed extract • thermus thermophillus ferment • caffeine • glycerin • lavandula angustifolia (lavender) oil • citrullus vulgaris (watermelon) fruit extract • lens esculenta (lentil) fruit extract • laminaria saccharina extract • pyrus malus (apple) fruit extract • acetyl hexapeptide-8 • palmaria palmata extract • sodium lactate • ascorbyl glucoside • tourmaline • caprylyl methicone • cetyl peg/ppg-10/1 dimethicone • caesalpinia spinosa gum • hydrolyzed wheat protein/pvp crosspolymer • caprylyl glycol • sodium pca • dimethicone/peg-10/15 crosspolymer • polyhydroxystearic acid • sodium hyaluronate • dimethicone crosspolymer-3 • triethoxycaprylylsilane • laureth-4 • alumina • dipropylene glycol • dextrin • pentylene glycol • citric acid • linalool • sodium benzoate • chlorphenesin • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499)] <iln44824>

Indications and usage

A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.
Use helps prevent sunburn

Purpose

Information about the drug product’s indications for use.
Purpose Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
TRACELESS TOUCH FOUNDATION BROAD SPECTRUM SPF 45 REFILL CUSHION COMPACT titanium dioxide and zinc oxide WATER DIMETHICONE BUTYLOCTYL SALICYLATE OCTYLDODECYL NEOPENTANOATE BUTYLENE GLYCOL ISONONYL ISONONANOATE LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE DIETHYLHEXYL SUCCINATE PHENYL TRIMETHICONE METHYL TRIMETHICONE SILICON DIOXIDE .ALPHA.-TOCOPHEROL ACETATE MAGNESIUM SULFATE, UNSPECIFIED FORM DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATE PHYMATOLITHON CALCAREUM NONI FRUIT SAPINDUS MUKOROSSI FRUIT LITCHI CHINENSIS SEED THERMUS THERMOPHILUS LYSATE CAFFEINE GLYCERIN LAVENDER OIL WATERMELON LENS CULINARIS FRUIT SACCHARINA LATISSIMA APPLE ACETYL HEXAPEPTIDE-8 PALMARIA PALMATA SODIUM LACTATE ASCORBYL GLUCOSIDE CAPRYLYL TRISILOXANE CAESALPINIA SPINOSA RESIN CAPRYLYL GLYCOL SODIUM PYRROLIDONE CARBOXYLATE HYALURONATE SODIUM TRIETHOXYCAPRYLYLSILANE LAURETH-4 ALUMINUM OXIDE DIPROPYLENE GLYCOL PENTYLENE GLYCOL CITRIC ACID MONOHYDRATE LINALOOL, (+/-)- SODIUM BENZOATE CHLORPHENESIN PHENOXYETHANOL MICA FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE

Package label principal display panel

The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.
PRINCIPAL DISPLAY PANEL - 12 g Jar Carton TOM FORD TRACELESS TOUCH FOUNDATION BROAD SPECTRUM SPF 45 REFILL SATIN-MATTE CUSHION COMPACT NET WT. .42 OZ./12 g e PRINCIPAL DISPLAY PANEL - 12 g Jar Carton

Spl unclassified section

Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.
Drug Facts

Do not use

Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.
Do not use on damaged or broken skin

Keep out of reach of children

Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Stop use

Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.
Stop use and ask a doctor if rash occurs

When using

Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.
When using this product keep out of eyes. Rinse with water to remove.

Storage and handling

Information about safe storage and handling of the drug product.
Other information protect the product in this container from excessive heat and direct sun

Warnings

Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.
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.

Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API