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| Product NDC Code | 75786-230 | ||||
|---|---|---|---|---|---|
| Drug Name | All good kids mineral sunscreen butter stick spf 50 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | OINTMENT | ||||
| Application Number | M020 | ||||
| Labeler Name | Elemental Herbs, Inc. | ||||
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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.Medicinal ingredient/Ingrédient médicinal: Zinc Oxide/Oxyde de zinc 25 %
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 Apply liberally/generously (and evenly) 15 minutes before sun exposure For use on children less than 6 months of age, consult a health care practitioner Reapply At least every 2 hours After 80 minutes of swimming or sweating Immediately after towel drying Mode d'emploi Appliquer généreusement (et uniformément) 15 minutes avant l'exposition au soleil Pour les enfants agés de moins de 6 mois, consulter un praticien de soins de santé Appliquer denouveau: au moins toutes les 2 heures aprés 80 minutes de baignade ou aprés avoir transpiré Immediatement apres s'etre séché a la serviette. 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 sun glasses. Mesures de protection contre le soleil Passer du temps au soleil augmente le risque de cancer de la peau et de vieillissement prématuré de la peau. Afin de diminuer ce risque, il convient d'utiliser réeguliérement un écran solaire avec un F.P.S. a 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 10 et 14 heures porter des chemises a manches longues, des pantalons, un chapeau et des lunettes de soleil.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Non-medicinal ingredients Calendula Officinalis (Calendula) Flower*, Cera Alba (Beeswax)* , Chamomilla Recutita Matricaria (Chamomile) Flower Extract*, Cocos Nucifera (Coconut) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Non-GMO Tocopherol (Vitamin E.) Ingrédients non m édicinaux Extrait de fleur de Calendula officinalis (calendule)*, cire d'abeille*,extrait de fleur de Chamomilla recutita matricaria (camomille)*, huile de coco*, huile de graines de Simmondsia chinensis (jojoba)*, tocophérol (Vitamine E). * CERTIFIED ORGANIC TO USDA/NOP STANDARDS * CERTIFIÉ BIOLOGIQUE SELON LES NORMES USDA/NOP
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.Recommended 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. Water/Sweat Resistant 80 minutes. Usages recommandés Aide a prévenir les coups de soleil. Si le produit est utilisé selon les instructions et avec d'autres mesures de protection contre le oleil [voir le Mode d'emploi], le risque de cancer de la peau et de viellissement prématuré de la peau causé par le soleil est réduit. Résistant l'eau/à la transpiration (80 minutes).
Purpose
Information about the drug product’s indications for use.Purpose/Utilité Sunscreen/Écran Solai
Spl product data elements
Usually a list of ingredients in a drug product.All Good kids mineral sunscreen butter stick SPF 50 Zinc Oxide MATRICARIA CHAMOMILLA LEAF COCONUT OIL TOCOPHEROL CALENDULA OFFICINALIS FLOWER WHITE WAX JOJOBA OIL 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 Tube Label
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.ALL GOOD kid's mineral sunscreen butter stick écran solaire minérale pour enfants bâtonnet de beurre NPN80076068 spf|fps50 NET WT/POIDS NET 2.75 OZ | 78 G NATURAL HEALTH PRODUCT | PRODUIT DE SANTE NATUREL BROAD SPECTRUM SPF50 | FPS50 À LARGE SPECTRE WATER/SWEAT RESISTANT (80 MIN) | RÉSISTANT À L'EAU/À LA TRANSPIRATION (80 MIN) CORAL REEF FRIENDLY | AMI DES RÉCIFS CORALLIENS NON-NANO BIODEGRADABLE NON NANO BIODEGRADABLE ALLGOODPRODUCTS.COM MADE IN USA FROM GLOBALLY-SOURCED INGREDIENTS | FABRIQUÉ AUX ÉTATS-UNIS À PARTIR D'INGREDIENTS DE SOURCE GLOBALE Imported by/Importé par: Quality Import Solutions Inc., Burlington, ON, L7L 6A3
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 la peau endommagée ou avec des lésions
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. Tenir hors de portée des enfants En cas d'ingestion, consulter un médecin ou appeler un centre antipoison immédiatement.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Skin Cancer/Skin Aging Alert Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging. Avertissement sur le cancer de la peau/le vieillissement de la peau Passer du temps au soleil augmente le risque de concer de la peau et de vieillissement prématuré de la peau. Ce produit s'est avéré pouvoir uniquement contribuer a prévenir les coups de soleil et non le cancer de la peau ou le viellissement cutané prématuré.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Question All Good, PO Box 203, Morro Bay, CA 93443
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.If rash occurs, discontinue use and consult a health care practitioner. En présence d'une éruption cutanée, cesser l'utilisation et consulter un praticien de soins de santé
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. Eviter tout contact avec les yeux. Rincer a l'eau le cas échéant
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.Risk Information For external use only Mention de risques Pour usage externe seulement Do not use on damaged or broken skin. Ne pas utiliser sur la peau endommagée ou avec des lésions If rash occurs, discontinue use and consult a health care practitioner. En présence d'une éruption cutanée, cesser l'utilisation et consulter un praticien de soins de santé When using this product keep out of eyes. Rinse with water to remove. Eviter tout contact avec les yeux. Rincer a l'eau le cas échéant Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Tenir hors de portée des enfants En cas d'ingestion, consulter un médecin ou appeler un centre antipoison immédiatement.
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