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| Product NDC Code | 83727-295 | ||||
|---|---|---|---|---|---|
| Drug Name | Skin laundry sun defense mineral spf 30 sunscreen broad spectrum spf 30 uva uvb |
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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 | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Skin Laundry Holdings, 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 Zinc Oxide 18.2% 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 ● Apply generously 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 ging. 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: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water (Aqua), Caprylic/Capric Triglyceride, C13-15 Alkane, Pentylene Glycol, C15-19 Alkane, Propanediol, Bis-Diglyceryl Polyacyladipate-2, Gluconolactone, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Cetearyl Alcohol, Inositol, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Coco-Glucoside, Arachidyl Alcohol, Polyglycerin-3, Polyglyceryl-3 Lactate/Laurate, Sodium Benzoate, Tocopherol, Xanthan Gum, Bisabolol, Behenyl Alcohol, Sodium Citrate, Sodium Dilauramidoglutamide Lysine, Sclerotium Gum, Arachidyl Glucoside, Citric Acid, Physalis Alkekengi Calyx Extract, Sodium Phytate, Calcium Gluconate, Beta-Carotene
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.Skin Laundry Sun Defense Mineral SPF 30 Sunscreen Broad Spectrum SPF 30 UVA UVB ZINC OXIDE ARACHIDYL GLUCOSIDE CITRIC ACID MONOHYDRATE ALKEKENGI OFFICINARUM CALYX PHYTATE SODIUM CALCIUM GLUCONATE BETA CAROTENE ZINC OXIDE ZINC CATION POLYGLYCERIN-3 SODIUM BENZOATE TOCOPHEROL XANTHAN GUM LEVOMENOL DOCOSANOL SODIUM CITRATE, UNSPECIFIED FORM SODIUM DILAURAMIDOGLUTAMIDE LYSINE WATER MEDIUM-CHAIN TRIGLYCERIDES C13-15 ALKANE PENTYLENE GLYCOL C15-19 ALKANE PROPANEDIOL BIS-DIGLYCERYL POLYACYLADIPATE-2 GLUCONOLACTONE AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) CETOSTEARYL ALCOHOL INOSITOL ISOSTEARIC ACID COCO GLUCOSIDE ARACHIDYL ALCOHOL BETASIZOFIRAN
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 Labeling: Outer Package2 Inner Package2
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 this container from excessive heat and direct sun
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 product is 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.Question or comments? Product Questions, email [email protected] You may report side effects to FDA at 1-800-FDA-1088
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 product is 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