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Product NDC Code | 81781-101 | ||||
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Drug Name | Daily face sunscreen broad spectrum spf 30 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | part352 | ||||
Labeler Name | Lilyana Naturals LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Zinc oxide 10% w/w
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 and evenly 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 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 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 Aloe Leaf Juice, Butyloctyl Salicylate, C15-19 Alkane, Isocetyl Stearoyl Stearate, Silica, Undecane, Tridecane, Tribehenin, Jojoba Seed Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Sunflower Seed Oil, Glyceryl Stearate, Tocopheryl Acetate, Grape Seed Oil, Leuconostoc/Radish Root Ferment Filtrate, Glycerin, Lactobacillus, Coconut Fruit Extract, Kakadu Plum Fruit Extract, Hyaluronic Acid, Panthenol, Acacia Gum (Gum arabic), Xanthan Gum, Allantoin
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.DAILY FACE SUNSCREEN Broad Spectrum SPF 30 Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF BUTYLOCTYL SALICYLATE C15-19 ALKANE ISOCETYL STEAROYL STEARATE SILICON DIOXIDE UNDECANE TRIDECANE TRIBEHENIN JOJOBA OIL CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) SUNFLOWER OIL GLYCERYL MONOSTEARATE .ALPHA.-TOCOPHEROL ACETATE GRAPE SEED OIL LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE GLYCERIN LACTOBACILLUS ACIDOPHILUS COCONUT KAKADU PLUM HYALURONIC ACID PANTHENOL ACACIA XANTHAN GUM ALLANTOIN
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.Packaging SUNSCREEN
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
CLEAN.VEGAN. • 90% Natural & Naturally-Derived Ingredients • Naturally Preserved with Radish Root CLEAN BEAUTY. SMART FORMULATIONS. AMAZING RESULTS. Lot No. : Expiry Date : @lilyana_naturals [email protected] www.lilyananaturals.com Product expires 12 months after first opening. Distributed by LilyAna Naturals LLC, PO Box 661, Collinsville, MS 39325
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.Questions? +1-800-619-7961 You may also report serious side effects to this phone number. Mon-Fri 9:00 AM - 5:00 PM
Storage and handling
Information about safe storage and handling of the drug product.Other information protect the product in this container 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 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