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| Product NDC Code | 54111-166 | ||||
|---|---|---|---|---|---|
| Drug Name | Nudescreen lip primer spf 30 - natural tint |
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| Type | Brand | ||||
| Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LIPSTICK | ||||
| Application Number | part352 | ||||
| Labeler Name | Bentley Laboratories, LLC | ||||
| 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.Drug Facts / Info-Médicament Active ingredient (w/w) / Ingrédient actif (p/p) Zinc Oxide 15%
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 / Mode d’emploi • Adults and children over 6 months. • Apply generously and evenly 15 minutes before sun exposure. • Reapply at least every 2 hours. • Reapply after eating or drinking/ • Adultes et enfants de plus de 6 mois • Appliquer abondamment/généreusement (et uniformément) 15 minutes avant l’exposition au soleil • Appliquer de nouveau au moins toutes les 2 heures • Appliquer de nouveau après avoir mangé ou bu • 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. / 11 a.m. – 3 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses • Test on a small area of skin before first use. If irritation occurs (within 24 hours), use a different product • Use a water-resistant sunscreen if swimming or sweating • Children under 6 months of age: ask a doctor / Mesures de protection solaire: Passer du temps au soleil augmente le risque de cancer de la peau et du vieillissement prématuré de la peau. Afin de diminuer ce risque, il convient d’utiliser régulièrement un écran solaire avec un F.P.S. à large spectre d’au moins 15 et d’appliquer d’autres mesures de protection contre le soleil, telles que: limiter le temps passé au soleil, notamment entre 10h - 14h / 11h - 15h • Porter des chemises à manches longues, des pantalons, un chapeau et des lunettes de soleil. • Avant d’utiliser, appliquer sur une petite surface de la peau. Si une irritation se produit (dans un délai de 24 heures), utiliser une autre produit que celui-ci. • Utiliser un écran solaire résistant à l’eau lors d’une activité aquatique ou s’il y a transpiration. • Enfants de moins de 6 mois: consulter un médecin
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients / Ingrédients inactifs Aqua/Water/Eau, Coconut Alkanes, Caprylic/Capric Triglyceride, Propanediol, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, Coco-Caprylate/Caprate, Methyl Dihydroabietate, Spirulina Platensis Extract, C13-15 Alkane, Sodium Chloride, Octyldodecanol, Distarch Phosphate, Isostearic Acid, Polyhydroxystearic Acid, Iron Oxides (CI 77492), Quaternium-90 Bentonite, 1,2-Hexanediol, Benzyl Alcohol, Hydroxyacetophenone, Zinc Stearate, Ethyl Ferulate, Iron Oxides (CI 77491), Butylene Glycol, Triethyl Citrate, Mica, Iron Oxides (CI 77499), Passiflora Edulis Fruit Extract, Titanium Dioxide (CI 77891),Sorbitan Oleate, Camellia Sinensis Leaf Extract
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 / Usages • Sun Protection Factor 30 • Sunscreen • Helps prevent sunburn • Broad Spectrum (SPF 30) • UVA/UVB Protection • 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. / • Facteur de protection solaire 30 • Crème solaire • Aide à prévenir les coups de soleil • F.P.S. 30 à Large spectre • Protection UVA/UVB • Si le produit est utilisé selon les instructions et avec d’autres mesures de protection contre le soleil [voir les Mode d’emploi] , le risque de cancer de la peau et de vieillissement prématuré de la peau causé par le soleil est réduit.
Purpose
Information about the drug product’s indications for use.Purpose / Utilite Sun Protectant
Spl product data elements
Usually a list of ingredients in a drug product.NUDESCREEN LIP PRIMER SPF 30 - NATURAL TINT ZINC OXIDE ZINC OXIDE ZINC CATION WATER COCONUT ALKANES MEDIUM-CHAIN TRIGLYCERIDES PROPANEDIOL POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE COCO-CAPRYLATE/CAPRATE METHYL DIHYDROABIETATE ARTHROSPIRA PLATENSIS C13-15 ALKANE SODIUM CHLORIDE OCTYLDODECANOL DISTARCH PHOSPHATE, CORN ISOSTEARIC ACID POLYHYDROXYSTEARIC ACID (2300 MW) FERRIC OXIDE YELLOW QUATERNIUM-90 BENTONITE 1,2-HEXANEDIOL BENZYL ALCOHOL HYDROXYACETOPHENONE ZINC STEARATE ETHYL FERULATE FERRIC OXIDE RED BUTYLENE GLYCOL TRIETHYL CITRATE MICA FERROSOFERRIC OXIDE PASSIFLORA EDULIS FRUIT TITANIUM DIOXIDE SORBITAN MONOOLEATE GREEN TEA LEAF
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 Package - NUDESTIX™ NUDESCREEN LIP PRIMER SPF 30 NUDE STIX™ NUDESCREEN LIP PRIMER SPF NATURAL TINT 10 mL / 0.34 FL OZ US MADE IN USA WITH GLOBALLY SOURCED COMPONENTS IMPORTED BY NUDESTIX INC. res 166-50
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/ Ne pas utiliser sur une peau abîmée ou ouverte
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, call a poison control centre or get medical help right away. / Tenir hors de portée des enfants . En cas d’ingestion, appeler immédiatement un centre antipoison ou obtenir une assistance médicale.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information/ Autres renseignements Protect the product in this container from excessive heat and direct sun. / Protégez le produit dans ce récipient de la chaleur excessive et du soleil direct.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? www.nudestix.com Made in USA with globally sourced components / fabriqué aux etats-unis avec des composants sourcés dans le monde
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 / Mises en garde For external use only / Pour usage externe seulement When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water. / Lorsque vous utilisez ce produit é viter tout contact avec les yeux. Le cas échéant, bien rincer avec de l’eau. Stop use and consult a health care practitioner if rash occurs. / Arrêter l’utilisation et consultez un professionnel de la santé en cas d’éruption cutanée
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