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Product NDC Code | 42893-033 | ||||
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Drug Name | Chantecaille just skin tinted moisturizer sunscreen broad spectrum spf 15 tan |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M020 | ||||
Labeler Name | Chantecaille Beaute Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient TITANIUM DIOXIDE 9.6075% Purpose 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 2 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, METHYL TRIMETHICONE, NEOPENTYL GLYCOL DIETHYLHEXANOATE, BUTYLENE GLYCOL, MICA, GLYCERIN, DIMETHICONE, DIPHENYLSILOXY PHENYL TRIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PENTYLENE GLYCOL, MAGNESIUM SULFATE, DISTEARDIMONIUM HECTORITE, DIMETHICONE/PEG-10/15 CROSSPOLYMER, POLYGLYCERYL-2 DIISOSTEARATE, CAESALPINIA SPINOSA FRUIT EXTRACT, STEARIC ACID, ALUMINUM HYDROXIDE, ALUMINA, KAPPAPHYCUS ALVAREZII EXTRACT, TOCOPHEROL, ISOSTEARIC ACID, SPIRODELA POLYRHIZA EXTRACT, ALCOHOL, ROSA DAMASCENA FLOWER WATER, LEONTOPODIUM ALPINUM FLOWER/LEAF EXTRACT, BUDDLEJA DAVIDII EXTRACT, THYMUS VULGARIS (THYME) FLOWER/LEAF EXTRACT, CAMELLIA SINENSIS LEAF EXTRACT, LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT, GLYCINE SOJA (SOYBEAN) PROTEIN, SODIUM DEXTRAN SULFATE, SUPEROXIDE DISMUTASE, ETHYLHEXYLGLYCERIN, PHENOXYETHANOL, SODIUM BENZOATE, POTASSIUM SORBATE, IRON OXIDES (CI 77491/CI 77492/Cl 77499)
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.Uses Helps prevent sunburn If used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun
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.Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 Tan TITANIUM DIOXIDE WATER METHYL TRIMETHICONE NEOPENTYL GLYCOL DIETHYLHEXANOATE BUTYLENE GLYCOL MICA GLYCERIN DIMETHICONE DIPHENYLSILOXY PHENYL TRIMETHICONE PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE PENTYLENE GLYCOL MAGNESIUM SULFATE, UNSPECIFIED FORM DISTEARDIMONIUM HECTORITE DIMETHICONE/PEG-10/15 CROSSPOLYMER POLYGLYCERYL-2 DIISOSTEARATE STEARIC ACID ALUMINUM HYDROXIDE ALUMINUM OXIDE KAPPAPHYCUS ALVAREZII TOCOPHEROL ISOSTEARIC ACID ALCOHOL ROSA X DAMASCENA FLOWER OIL LEONTOPODIUM NIVALE SUBSP. ALPINUM FLOWERING TOP THYME GREEN TEA LEAF LONICERA JAPONICA FLOWER SOYBEAN SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) ETHYLHEXYLGLYCERIN PHENOXYETHANOL SODIUM BENZOATE POTASSIUM SORBATE FERRIC OXIDE RED 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.Package Labelling: Outer Label.jpg Inner Label.jpg
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
Other Information Protect the product in this container from excessive heat and direct sun Do not use if carton is open or if seal underneath tube cap is missing or broken
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 swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-877-673-7080 Chantecaille.com
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.
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 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