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| Product NDC Code | 76446-648 | ||||
|---|---|---|---|---|---|
| Drug Name | Rosease by anna lotan gentle daytime 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 | 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: Octinoxate 7.5% 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 and evenly 15 minutes before sun exposure. Reapply at least every 2 hours. Use water-resistant sunscreen if swimming or sweating. For children under 6 months of age: 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), butyloctyl salicylate, glycerin, dimethicone, styrene/acrylates copolymer, coco-caprylate/caprate, caprylic/capric triglyceride, vp/eicosene copolymer, carthamus tinctorius oleosomes, elettaria cardamomum seed extract, aloe barbadensis leaf juice, tocopheryl acetate, perilla frutescens extract, pyrus malus (apple) fruit extract, rose extract, santalum album extract, camellia sinensis leaf extract, anthemis nobilis flower extract, cananga odorata flower extract, citrus aurantium dulcis (orange) peel extract, cucumis melo (melon) fruit extract, cucumis sativus fruit extract, jasminum officinale flower/leaf extract, lavandula angustifolia (lavender) flower / leaf / stem extract, rubus idaeus (raspberry) fruit extract, polygonum aviculare extract, vitis vinifera fruit cell extract, propanediol, cetearyl alcohol, pentylene glycol, arachidyl alcohol, polyhydroxystearic acid, cocoglucoside, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, behenyl alcohol, xanthan gum, triethoxycaprylylsilane, arachidyl glucoside, phenethyl alcohol, caprylyl glycol.
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.
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.Rosease By Anna Lotan Gentle Daytime Broad Spectrum SPF 30 Octinoxate, Zinc Oxide OCTINOXATE OCTINOXATE ZINC OXIDE ZINC OXIDE WATER BUTYLOCTYL SALICYLATE GLYCERIN DIMETHICONE STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) COCOYL CAPRYLOCAPRATE MEDIUM-CHAIN TRIGLYCERIDES VINYLPYRROLIDONE/EICOSENE COPOLYMER CARTHAMUS TINCTORIUS SEED OLEOSOMES CARDAMOM ALOE VERA LEAF .ALPHA.-TOCOPHEROL ACETATE PERILLA FRUTESCENS LEAF APPLE ROSA CENTIFOLIA FLOWER SANDALWOOD GREEN TEA LEAF CHAMAEMELUM NOBILE FLOWER CANANGA ODORATA FLOWER ORANGE PEEL MUSKMELON CUCUMBER JASMINUM OFFICINALE FLOWER LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP RASPBERRY POLYGONUM AVICULARE TOP VITIS VINIFERA HIGH TANNIN CULTIVAR FRUIT CELL LYSATE PROPANEDIOL CETOSTEARYL ALCOHOL PENTYLENE GLYCOL ARACHIDYL ALCOHOL POLYHYDROXYSTEARIC ACID (2300 MW) COCO GLUCOSIDE HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) DOCOSANOL XANTHAN GUM TRIETHOXYCAPRYLYLSILANE ARACHIDYL GLUCOSIDE PHENYLETHYL ALCOHOL CAPRYLYL GLYCOL
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:
ENRICHED WITH BOTANICAL EXTRACTS EXCELLENT SKIN TOLERANCE FREE RADICAL PROTECTION For All Skin Types 8 DERMATOLOGICALLY TESTED TENDER LOVING CARE NON-IRRITATING THE ROSEASE TOOLKIT Distributed by: Anna Lotan USA Inc. 16 Wheeling Ave. Woburn, MA 01801 www .annalotanusa.com
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