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Product NDC Code | 83748-001 | ||||
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Drug Name | Sunscreen |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | NATURAL AND ORGANIC FORMULATIONS (PTY) LTD | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.30mL Sunscreen Label Drug Facts Active Ingredient Section
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.30mL Sunscreen Label Drug Facts Directions Section 30mL Sunscreen Label Drug Facts Directions Continued Section
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.30mL Sunscreen Label Drug Facts Inactive Ingredient Section
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.30mL Sunscreen Label Drug Facts Uses Section
Purpose
Information about the drug product’s indications for use.30mL Sunscreen Label Drug Facts Purpose Section
Spl product data elements
Usually a list of ingredients in a drug product.Sunscreen Sunscreen, zinc oxide SHOREA ROBUSTA RESIN DEHYDROACETIC ACID POLYGLYCERYL-3 DIISOSTEARATE ZINC SULFATE ASPALATHUS LINEARIS LEAF SUNFLOWER OIL OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES ASCORBYL PALMITATE TOXICODENDRON VERNICIFLUUM FRUIT RIND WAX MYROTHAMNUS FLABELLIFOLIA LEAF POLYGLYCERYL-3 PENTARICINOLEATE ISOSTEARIC ACID TOXICODENDRON SUCCEDANEUM FRUIT WAX LECITHIN, SOYBEAN MEDIUM-CHAIN TRIGLYCERIDES JOJOBA OIL HELIANTHUS ANNUUS SEED WAX ALOE VERA LEAF FERRIC OXIDE RED TOCOPHEROL HYDROGENATED SOYBEAN LECITHIN GLYCERYL OLEATE FERRIC OXIDE YELLOW ZINC OXIDE ZINC OXIDE ISOAMYL LAURATE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE SHEA BUTTER OLEA EUROPAEA LEAF POLYHYDROXYSTEARIC ACID (2300 MW) FERROSOFERRIC OXIDE BENZYL ALCOHOL WATER
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.30mL Sunscreen label Principal Display Panel 30mL Sunscreen Label PDP
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.30mL Sunscreen Label Drug Facts Children Section
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.30mL Sunscreen Label Drug Facts Warnings Section
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