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| Product NDC Code | 76446-300 | ||||
|---|---|---|---|---|---|
| Drug Name | Anna lotan lightly tinted mineral day cream broad spectrum spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Anna Lotan Ltd | ||||
| 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 Ingredients Titanium Dioxide 7.75% Zinc Oxide 10.0%
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 to all skin exposed to the sun • apply liberally 15 minutes before sun exposure • reapply at least every 2 hours • use water resistant sunscreen if swimming or sweating • for children under 6 months: Ask a doctor • 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 sun from 10 a.m.- 2 p.m. • wear long-sleeved shirts, pants, hats and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water (aqua), caprylic/capric triglyceride, butyloctyl salicylate, glycerin, dimethicone, styrene/acrylates copolymer, coco-caprylate/caprate, aluminum stearate, carthamus tinctorius oleosomes, polyhydroxystearic acid, aloe barbadensis leaf juice, polygonum aviculare extract, tocopheryl acetate, perilla frutescens extract, vitis vinifera fruit cell extract, lepidium sativum sprout extract, squalane, cetearyl alcohol, isononyl isononanoate, coco-glucoside, pentylene glycol, behenyl alcohol, xanthan gum, triethoxycaprylylsilane, arachidyl glucoside, simmondsia chinensis (jojoba) seed oil, stearic acid, sucrose stearate, phenethyl alcohol, tetrahexyldecyl ascorbate, glyceryl caprylate, ethylene/propylene/styrene copolymer, sorbitan oleate, polyglyceryl-2 caprate, propanediol, alumina, arachidyl alcohol, iron oxides (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 protective 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.Anna Lotan Lightly Tinted Mineral Day Cream Broad Spectrum SPF 30 Titanium Dioxide, Zinc Oxide TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES BUTYLOCTYL SALICYLATE GLYCERIN DIMETHICONE STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) COCOYL CAPRYLOCAPRATE ALUMINUM STEARATE CARTHAMUS TINCTORIUS SEED OLEOSOMES POLYHYDROXYSTEARIC ACID (2300 MW) ALOE VERA LEAF POLYGONUM AVICULARE TOP .ALPHA.-TOCOPHEROL ACETATE PERILLA FRUTESCENS LEAF VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE GARDEN CRESS SPROUT SQUALANE CETOSTEARYL ALCOHOL ISONONYL ISONONANOATE COCO GLUCOSIDE PENTYLENE GLYCOL DOCOSANOL XANTHAN GUM TRIETHOXYCAPRYLYLSILANE ARACHIDYL GLUCOSIDE JOJOBA OIL STEARIC ACID SUCROSE STEARATE PHENYLETHYL ALCOHOL TETRAHEXYLDECYL ASCORBATE GLYCERYL MONOCAPRYLATE SORBITAN MONOOLEATE POLYGLYCERYL-2 CAPRATE PROPANEDIOL ALUMINUM OXIDE ARACHIDYL ALCOHOL 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.Packaging 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.Drug Facts
For all skin types This lightly tinted daytime moisturizer provides broad spectrum protection based on minerals alone excluding chemical absorbers. The formula is enriched with skin friendly, sustainable emollients which are easily absorbed by the skin while minimizing the white appearance common to mineral based sunscreens. A wide range of free radical scavengers provides the antioxidant protection which is vital during exposure to UV light. Vitamin E supported by a stable ester form of Vitamin C protects the skin’s own lipids as well as the seed oils in the formula. Extracts of Garden Cress sprouts and Grapes contribute their antioxidants to the water based part of the composition. Distributed by: Anna Lotan USA Inc. 16 Wheeling Ave, Woburn, MA 01801 www.annalotanusa.com [email protected]
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or Comments? (781) 281-0954
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
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.
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