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| Product NDC Code | 11559-057 | ||||
|---|---|---|---|---|---|
| Drug Name | Re-nutriv ultra radiance makeup broad spectrum spf 20 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIQUID | ||||
| Application Number | M020 | ||||
| Labeler Name | ESTEE LAUDER INC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Purpose Octinoxate 2.2% Sunscreen Titanium Dioxide 1.4% Sunscreen
| Octinoxate 2.2% | Sunscreen |
| Titanium Dioxide 1.4% | 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 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 • methyl trimethicone • dimethicone • butylene glycol • isocetyl alcohol • peg/ppg-18/18 dimethicone • rhodochrosite extract • caprylic/capric triglyceride • isohexadecane • sorbitan sesquioleate • magnesium sulfate • wheat germ glycerides • tribehenin • olivine extract • laminaria digitata extract • sodium hyaluronate • trifluoroacetyl tripeptide-2 • palmitoyl tripeptide-1 • pearl powder • gold • ruby powder • sapphire powder • nephrite powder • citrullus vulgaris (watermelon) fruit extract • pyrus malus (apple) fruit extract • lens esculenta (lentil) fruit extract • algae extract • oryza sativa (rice) bran extract • gentiana lutea (gentian) root extract • ascorbyl palmitate • ergothioneine • simmondsia chinensis (jojoba) seed oil • tocopheryl acetate • hydrolyzed wheat protein • linoleic acid • laureth-7 • triethyl citrate • stearic acid • ethylhexylglycerin • polymethylsilsesquioxane • cholesterol • hydrogenated lecithin • glycerin • ethylhexyl palmitate • propylene carbonate • polyphenylsilsesquioxane • polysilicone-11 • sodium lactate • triethoxycaprylylsilane • tocopherol • sodium pca • sorbitan isostearate • sorbitan stearate • magnesium ascorbyl phosphate • aluminum hydroxide • methicone • xanthan gum • cetyl peg/ppg-10/1 dimethicone • lauryl peg-9 polydimethylsiloxyethyl dimethicone • disteardimonium hectorite • dextran • boron nitride • sodium metabisulfite • fragrance (parfum) • bht • pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate • sorbic acid • sodium benzoate • potassium sorbate • chloroxylenol • phenoxyethanol • [+/- mica • titanium dioxide (ci 77891) • iron oxides (ci 77492) • iron oxides (ci 77491) • iron oxides (ci 77499)] <iln46282>
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 2.2% Sunscreen Titanium Dioxide 1.4% Sunscreen
| Octinoxate 2.2% | Sunscreen |
| Titanium Dioxide 1.4% | Sunscreen |
Spl product data elements
Usually a list of ingredients in a drug product.RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20 OCTINOXATE and TITANIUM DIOXIDE WATER PHENYL TRIMETHICONE METHYL TRIMETHICONE DIMETHICONE BUTYLENE GLYCOL ISOCETYL ALCOHOL PEG/PPG-18/18 DIMETHICONE MEDIUM-CHAIN TRIGLYCERIDES ISOHEXADECANE SORBITAN SESQUIOLEATE MAGNESIUM SULFATE, UNSPECIFIED FORM WHEAT GERM OIL TRIBEHENIN LAMINARIA DIGITATA HYALURONATE SODIUM PALMITOYL TRIPEPTIDE-1 PEARL (HYRIOPSIS CUMINGII) GOLD WATERMELON APPLE LENS CULINARIS FRUIT RICE BRAN GENTIANA LUTEA ROOT ASCORBYL PALMITATE ERGOTHIONEINE JOJOBA OIL .ALPHA.-TOCOPHEROL ACETATE HYDROLYZED WHEAT PROTEIN (ENZYMATIC; 3000 MW) LINOLEIC ACID LAURETH-7 TRIETHYL CITRATE STEARIC ACID ETHYLHEXYLGLYCERIN POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) CHOLESTEROL HYDROGENATED SOYBEAN LECITHIN GLYCERIN ETHYLHEXYL PALMITATE PROPYLENE CARBONATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) SODIUM LACTATE TRIETHOXYCAPRYLYLSILANE TOCOPHEROL SODIUM PYRROLIDONE CARBOXYLATE SORBITAN ISOSTEARATE SORBITAN MONOSTEARATE MAGNESIUM ASCORBYL PHOSPHATE ALUMINUM HYDROXIDE METHICONE (20 CST) XANTHAN GUM LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE DISTEARDIMONIUM HECTORITE BORON NITRIDE SODIUM METABISULFITE BUTYLATED HYDROXYTOLUENE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) SORBIC ACID SODIUM BENZOATE POTASSIUM SORBATE CHLOROXYLENOL PHENOXYETHANOL MICA FERRIC OXIDE YELLOW FERRIC OXIDE RED 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 - 30 ml Tube Carton Re-Nutriv ESTĒE LAUDER Ultra Radiance Liquid Makeup Broad Spectrum SPF 20 1 FL. OZ. LIQ. 30 ml e Principal Display Panel
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