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| Product NDC Code | 50021-600 | ||||
|---|---|---|---|---|---|
| Drug Name | Spf 40 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part352 | ||||
| Labeler Name | Empack Spraytech 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 ingredient (w/w) Zinc Oxide 20.5%
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 Adults, adolescents, and children over 6 months of age • Apply liberally and evenly 15 minutes before sun exposure • Reapply: • at least 2 hours • after 40 minutes of swimming or sweating • immediately after towel drying • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the 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. and • wear long-sleeved shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aloe Barbadensis Leaf Juice, Ammonium Acryloyldimethyltaurate/VP Copolymer, Aqua/Water/Eau, Bambusa Arundinacea Stem Extract, Camellia Sinensis Leaf Extract, Caprylic/Capric Triglyceride, Dilauryl Citrate, Ethylhexylglycerin, Ginkgo Biloba Leaf Extract, Gluconolactone, Glycerin, Hydrogenated Methyl Abietate, Isopropyl Palmitate, Lauryl Glucoside, Leuconostoc/Radish Root Ferment Filtrate, Lonicera Caprifolium (Honeysuckle) Flower Extract, Lonicera Japonica (Honeysuckle) Flower Extract, Methylcellulose, Octyldodecyl Citrate Crosspolymer, Phenoxyethanol, Polyglyceryl-4 Laurate, Polyhydroxystearic Acid, Populus Tremuloides Bark Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Sodium Lauryl Glucose Carboxylate, Sodium Phytate, Sodium Stearoyl Glutamate, Sorbitan Laurate, Tocopherol, Xanthan Gum
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.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.SPF 40 ZINC OXIDE DILAURYL CITRATE GINKGO POLYHYDROXYSTEARIC ACID (2300 MW) METHYLCELLULOSE, UNSPECIFIED PHYTATE SODIUM GLUCONOLACTONE GLYCERIN OCTYLDODECYL CITRATE CROSSPOLYMER HYDROGENATED METHYL ABIETATE LAURYL GLUCOSIDE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE LONICERA JAPONICA FLOWER ALOE VERA LEAF AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER ETHYLHEXYLGLYCERIN ISOPROPYL PALMITATE LONICERA CAPRIFOLIUM FLOWER PHENOXYETHANOL SODIUM LAURYL GLYCOL CARBOXYLATE SORBITAN MONOLAURATE TOCOPHEROL XANTHAN GUM POLYGLYCERYL-3 LAURATE POPULUS TREMULOIDES BARK WATER BAMBUSA ARUNDINACEA STEM GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES JOJOBA OIL SODIUM STEAROYL GLUTAMATE 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.SPF 40 Tilley Ensurables BROAD SPECTRUM UVA / UVB PROTECTION MINERAL SUNSCREEN WATER / SWEAT RESISTANT (40 MIN) Net Wt. 5 oz. (142 g) Refer to attachment, Label - Tilley SPF 40 for label artwork. Label - Tilley SPF 40
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 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. Topical. If swallowed, call a poison control centre or get medical help right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect the product in this container from excessive heat and direct sun. May stain surfaces and fabrics.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-ENDURES or visit www.tilley.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 avoid contact with eyes. If contact occurs, rinse thoroughly with water.
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.
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