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Tom ford soleil glow tinted moisturizer broad spectrum spf 15 - Medication Information

Product NDC Code 76398-012
Drug Name

Tom ford soleil glow tinted moisturizer broad spectrum spf 15

Type Brand
Active Ingredients
Octinoxate 75 mg/ml
Titanium dioxide 29 mg/ml
Route TOPICAL
Dosage Form LIQUID
Application Number M020
Labeler Name TOM FORD BEAUTY DIST
Packages
Package NDC Code Description
76398-012-01 1 tube in 1 carton (76398-012-01) / 50 ml in 1 tube
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredients Purpose Octinoxate 7.5% Sunscreen Titanium Dioxide 2.9% Sunscreen
Active IngredientsPurpose
Octinoxate 7.5%Sunscreen
Titanium Dioxide 2.9%Sunscreen

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 and evenly 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 • phenyl trimethicone • butylene glycol • pentaerythrityl tetraethylhexanoate • simmondsia chinensis (jojoba) seed oil • petrolatum • biosaccharide gum - 1 • steareth-21 • glyceryl stearate • tocopheryl acetate • sodium hyaluronate • ethylhexylglycerin • peg-12 dimethicone • isohexadecane • magnesium aluminum silicate • xanthan gum • lecithin • aluminum hydroxide • citric acid • steareth-2 • polymethyl methacrylate • cetyl alcohol • potassium stearate • acrylamide/sodium acryloyldimethyltaurate copolymer • polysorbate 80 • caprylyl glycol • lavandula angustifolia (lavender) oil • linalool • tocopherol • phenoxyethanol • bht • sorbic acid • disodium edta • [+/-titanium dioxide (ci 77891) • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499)] <iln47202>

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.
Active Ingredients Purpose Octinoxate 7.5% Sunscreen Titanium Dioxide 2.9% Sunscreen
Active IngredientsPurpose
Octinoxate 7.5%Sunscreen
Titanium Dioxide 2.9%Sunscreen

Spl product data elements

Usually a list of ingredients in a drug product.
TOM FORD SOLEIL GLOW TINTED MOISTURIZER BROAD SPECTRUM SPF 15 OCTINOXATE and TITANIUM DIOXIDE WATER PHENYL TRIMETHICONE BUTYLENE GLYCOL PENTAERYTHRITYL TETRAETHYLHEXANOATE JOJOBA OIL PETROLATUM BIOSACCHARIDE GUM-1 STEARETH-21 GLYCERYL MONOSTEARATE .ALPHA.-TOCOPHEROL ACETATE HYALURONATE SODIUM ETHYLHEXYLGLYCERIN PEG-12 DIMETHICONE (300 CST) ISOHEXADECANE MAGNESIUM ALUMINUM SILICATE XANTHAN GUM ALUMINUM HYDROXIDE CITRIC ACID MONOHYDRATE STEARETH-2 POLY(METHYL METHACRYLATE; 450000 MW) CETYL ALCOHOL POTASSIUM STEARATE POLYSORBATE 80 CAPRYLYL GLYCOL LAVENDER OIL LINALOOL, (+/-)- TOCOPHEROL PHENOXYETHANOL BUTYLATED HYDROXYTOLUENE SORBIC ACID EDETATE DISODIUM ANHYDROUS FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE

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 - 50 ml Tube Carton TOM FORD SOLEIL GLOW TINTED MOISTURIZER BROAD SPECTRUM SPF 15 1.7 FL. OZ./OZ. LIQ./50 ml e PRINCIPAL DISPLAY PANEL - 50 ml Tube 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