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| Product NDC Code | 77394-202 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Lather- daily defense mineral spf 50 |
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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 | CREAM | ||||||
| Application Number | part352 | ||||||
| Labeler Name | Lather, 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 21%
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 reapply: after 80 minutes of swimming or sweating immediately after towel drying at least 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 from 10 a.m. - 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.INACTIVE INGREDIENTS Water (aqua), Coco-Caprylate/Caprate, Cetearyl Alcohol, Propanediol, Stearyl Alcohol, Polyhydroxystearic Acid, Mica, Butyrospermum Parkii (Shea) Butter, Cetearyl Olivate, Sorbitan Olivate, Camellia Sinensis (Green Tea) Extract, Olea Europaea (Olive) Leaf Extract, Equisetum Arvense (Horsetail) Extract, Rosmarinus Officinalis (rosemary) Extract, Centella Asiatica (Gotu Kola) Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Glyceryl Caprylate, Glycerin, Xanthan Gum, Tocopheryl Acetate, Citrus Nobilis (Mandarin Orange) Peel Oil, Silica, Caprylhydroxamic Acid, Triethoxycaprylylsilane, Ascorbyl Palmitate, Caprylic/Capric Triglyceride, Ascorbic Acid, Tocopherol, Potassium Sorbate, Sodium Phytate, Citric Acid, 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.LATHER- DAILY DEFENSE MINERAL SPF 50 ZINC OXIDE WATER COCO-CAPRYLATE/CAPRATE CETYL ALCOHOL PROPANEDIOL STEARYL ALCOHOL POLYHYDROXYSTEARIC ACID (2300 MW) MICA BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES CETEARYL OLIVATE SORBITAN OLIVATE CAMELLIA SINENSIS FLOWER OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES EQUISETUM ARVENSE WHOLE ROSMARINUS OFFICINALIS FLOWER CENTELLA ASIATICA AESCULUS HIPPOCASTANUM FLOWER COCOS NUCIFERA WHOLE HELIANTHUS ANNUUS SEED WAX GLYCERYL CAPRYLATE GLYCERIN XANTHAN GUM .ALPHA.-TOCOPHEROL ACETATE CITRUS NOBILIS SILICON DIOXIDE CAPRYLHYDROXAMIC ACID TRIETHOXYCAPRYLYLSILANE ASCORBYL PALMITATE CAPRYLIC/CAPRIC/SUCCINIC TRIGLYCERIDE ASCORBIC ACID TOCOPHEROL POTASSIUM SORBATE PHYTATE SODIUM CITRIC ACID ACETATE BROWN IRON OXIDE 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.01b UC_Daily-Defense-Mineral-SPF50_2oz_BOX_FDA2
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, get medical help or contact a Poison Control Center right away.
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 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. If product is swallowed, get medical help or contact a Poison Control Center right away.
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