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Product NDC Code | 73665-102 | ||||||||
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Drug Name | Kari gran essential spf spf 30 |
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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 | SOLUTION | ||||||||
Application Number | M020 | ||||||||
Labeler Name | KARI GRAN | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENT NON-NANO ZINC OXIDE 18%
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 SHAKE WELL. APPLY AT LEAST 1 PUMP TO FACE. APPLY ADDITIONAL PUMPS TO NECK AND CHEST - AREAS THAT ARE OFTEN IGNORED. APPLY LIBERALLY 15 MINUTES BEFORE SUN EXPOSURE. REAPPLY EVERY 2 HOURS 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 OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES INCLUDING: LIMIT TIME IN THE SUN, ESPECIALLY BETWEEN 10 A.M. AND 2 P.M. WEAR LONG-SLEEVED SHIRTS, PANTS, HATS AND SUNGLASSES CHILDREN UNDER 6 MONTHS: CONSULT A PHYSICIAN
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS UNTINTED: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+ TINTED, LIGHT: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica. TINTED, MEDIUM: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica. TINTED, DARK: Rubus Ideaus (Red Raspberry) Seed Oil++, Prunus Domestica (French Plum) Seed Oil*, Macadamia Ternifolia (Macadamia Nut) Seed Oil*, Aleurites Moluccana (Kukui) Seed Oil++, Persea Gratissima (Avocado) Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Beeswax*, Tocopherol+, Titanium Dioxide, Iron Oxides, Mica, Ultramarines. *certified organic +non-GMO Vitamin E from Sunflower ++ non-GMO
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.KARI GRAN ESSENTIAL SPF SPF 30 ZINC OXIDE TITANIUM DIOXIDE MICA FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW ULTRAMARINE BLUE KUKUI NUT OIL RASPBERRY SEED OIL PLUM SEED OIL MACADAMIA OIL AVOCADO OIL JOJOBA OIL YELLOW WAX TOCOPHEROL FERRIC OXIDE RED ZINC OXIDE ZINC CATION
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.0-UC_Essential SPF-30 0-Image_Essential SPF-30
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, SEEK MEDICAL ATTENTION 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 OR COMMENTS? CALL MONDAY THROUGH FRIDAY, 206-588-1573 (9 A.M. TO 5 P.M. PST)
Storage and handling
Information about safe storage and handling of the drug product.KEEP THIS PRODUCT AWAY FROM EXCESSIVE HEAT AND DIRECT SUNLIGHT
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.
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