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| Product NDC Code | 71499-045 | ||||
|---|---|---|---|---|---|
| Drug Name | Ole henriksen banana bright mineral sunscreen spf 30 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | KENDO 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 INGREDIENTS ZINC OXIDE 16.32%
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 15 MINUTES BEFORE SUN EXPOSURE. USE A WATER RESISTANT SUNSCREEN IF SWIMMING OR SWEATING. REAPPLY AT LEAST EVERY 2 HOURS. 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 SUNCREEN 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS WATER, MEDIUM-CHAIN TRIGLYCERIDES, BUTYLOCTYL SALICYLATE, PROPANEDIOL, NIACINAMIDE, ALOE VERA LEAF, 1,2-HEXANEDIOL, SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, SQUALANE, TETRAHEXYLDECYL ASCORBATE, ORANGE, ORANGE PEEL, LIMOSILACTOBACILLUS FERMENTUM, PANTHENOL, TOCOPHEROL, GLUCONOLACTONE, GLYCERIN, JOJOBA ESTERS, SUNFLOWER OIL, GLYCERYL MONOSTEARATE, CETYL ALCOHOL, CALCIUM GLUCONATE, GLYCOL STEARATE, LECITHIN, SORBITAN MONOOLEATE, STARCH, HYDROXYACETOPHENONE, ISOSTEARIC ACID, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, ISOHEXADECANE, XANTHAN GUM, CANOLA OIL, POLYSORBATE 80, POTASSIUM SORBATE, SODIUM BENZOATE, CITRIC ACID, OCTYLDODECANOL, LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE, CITRAL, LIMONENE, LINALOOL, TITANIUM DIOXIDE, IRON OXIDES
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.OLE HENRIKSEN BANANA BRIGHT MINERAL SUNSCREEN SPF 30 ZINC OXIDE MEDIUM-CHAIN TRIGLYCERIDES STARCH, TAPIOCA OCTYLDODECANOL POLYGLYCERYL-3 PENTARICINOLEATE POLYHYDROXYSTEARIC ACID (2300 MW) POLYSORBATE 80 TITANIUM DIOXIDE BUTYLOCTYL SALICYLATE PROPANEDIOL 1,2-HEXANEDIOL SODIUM ACRYLATE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER (4000000 MW) TETRAHEXYLDECYL ASCORBATE SQUALANE ORANGE ORANGE PEEL LIMOSILACTOBACILLUS FERMENTUM PANTHENOL GLUCONOLACTONE ALOE VERA LEAF GLYCERIN SORBITAN MONOOLEATE HYDROGENATED JOJOBA OIL, RANDOMIZED SUNFLOWER OIL GLYCERYL MONOSTEARATE CANOLA OIL XANTHAN GUM CITRIC ACID MONOHYDRATE CETYL ALCOHOL SODIUM BENZOATE GLYCOL STEARATE HYDROXYACETOPHENONE FERROUS OXIDE ISOHEXADECANE LECITHIN, SOYBEAN LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE POTASSIUM SORBATE TOCOPHEROL BENZYL SALICYLATE CITRAL NIACINAMIDE LIMONENE, (+)- LINALOOL, (+/-)- WATER ZINC OXIDE ZINC 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.01b UC_Banana Bright Mineral Sunscreen_50mL
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 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? OLEHENRIKSEN.COM
Storage and handling
Information about safe storage and handling of the drug product.OTHER INFORMATION PROTECT THIS PRODUCT 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. STOP USE AND ASK A DOCTOR IF RASH OCCURS. WHEN USING THIS PRODUCT KEEP OUT OF EYES. RINSE WITH WATER TO REMOVE.
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