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| Product NDC Code | 55560-5003 | ||||
|---|---|---|---|---|---|
| Drug Name | Spf30 sheer touch tinted sunscreen medium - dark |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | part347 | ||||
| Labeler Name | Andalou naturals | ||||
| 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 Zinc Oxide (21.5%)
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 Apply liberally 15minutes before sun exposure reapply: after swimming, sweating, immediately after towel drying every 2 hours Sun protection measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. To decrease this risk regularly use a sunscreen with broad spectrum protection value of SPF15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am to 2pm wear long sleeved shirts, pants, hat 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 Aqua/Water/Eau, Isoamyl Laurate, Caprylic/Capric Triglyceride, Sorbitan Stearate, Cetearyl Alcohol, Hydroxypropyl Starch Phosphate, Phenethyl Alcohol, Caprylyl Glycol, Glyceryl Isostearate, Xanthan Gum, Polyhydroxystearic Acid, Cetearyl Glucoside, Sucrose Cocoate, Rosa Canina Fruit Oil, Carthamus Tinctorius (Safflower) Seed Oil, Glycerin, Cucumis Sativus (Cucumber) Fruit Extract, Camellia Sinensis Leaf Extract, Potassium Sorbate, Fragrance (Parfum), CI 77492, CI 77491, CI 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 early skin ageing 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.SPF30 SHEER TOUCH TINTED SUNSCREEN LIGHT - MEDIUM ZINC OXIDE ZINC OXIDE ZINC OXIDE WATER ISOAMYL LAURATE MEDIUM-CHAIN TRIGLYCERIDES SORBITAN MONOSTEARATE CETOSTEARYL ALCOHOL PHENYLETHYL ALCOHOL CAPRYLYL GLYCOL GLYCERYL ISOSTEARATE XANTHAN GUM CETEARYL GLUCOSIDE SUCROSE COCOATE ROSA CANINA FRUIT OIL SAFFLOWER OIL GLYCERIN CUCUMBER GREEN TEA LEAF POTASSIUM SORBATE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE SPF30 SHEER TOUCH TINTED SUNSCREEN MEDIUM - DARK ZINC OXIDE ZINC OXIDE ZINC OXIDE WATER ISOAMYL LAURATE MEDIUM-CHAIN TRIGLYCERIDES SORBITAN MONOSTEARATE CETOSTEARYL ALCOHOL PHENYLETHYL ALCOHOL CAPRYLYL GLYCOL GLYCERYL ISOSTEARATE XANTHAN GUM CETEARYL GLUCOSIDE SUCROSE COCOATE ROSA CANINA FRUIT OIL SAFFLOWER OIL GLYCERIN CUCUMBER GREEN TEA LEAF POTASSIUM SORBATE FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC 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 - 60 mL Tube Carton - LIGHT - MEDIUM sukin ® AUSTRALIAN • NATURAL SUNCARE • REEF SAFE • REEF SAFE SPF30 SHEER TOUCH TINTED SUNSCREEN UVA & UVB BROAD SPECTRUM LIGHT - MEDIUM NO OXYBENZONE 60mL/2.03 fl oz PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - LIGHT - MEDIUM
PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - MEDIUM - DARK sukin ® AUSTRALIAN • NATURAL SUNCARE • REEF SAFE • REEF SAFE SPF30 SHEER TOUCH TINTED SUNSCREEN UVA & UVB BROAD SPECTRUM MEDIUM - DARK NO OXYBENZONE 60mL/2.03 fl oz PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton - MEDIUM - DARK
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 eyes. Rinse with water to remove
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 centre 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? Call: AUS: 1300 858 898 CANADA: 1-888-464-6775
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 a rash occurs
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect this product from excessive heat and direct sun may stain some fabrics.
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 Keep out of eyes. Rinse with water to remove Stop use and ask a doctor if a rash occurs Keep out of reach of children. If swallowed, get medical help or contact a poison control centre 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