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| Product NDC Code | 83387-399 | ||||
|---|---|---|---|---|---|
| Drug Name | Mineral sunscreen 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 | LIQUID | ||||
| Application Number | M020 | ||||
| Labeler Name | NEWCO LLC | ||||
| 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 Ingredient Titanium Dioxide 6.00% Zinc Oxide 6.00% Purpose Sunscreen
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 and as needed. • Children under 6 months of age: Ask a doctor. • After 80 minutes of swimming or sweating. • Immediately after towel drying. • At least every 2 hours. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with 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-sleeved shirts, pants, hats, and sunglasses. Reapply: Sun Protection Measures:
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Other Ingredients: *Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), *Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl/Capryl Glucoside, *Carthamus Tinctorius (Safflower) Oil, Ethylhexylglycerin, *Glycerin, Glyceryl Stearate Citrate, *Helianthus Annuus (Sunflower) Oil, Lecithin, Phenoxyethanol, Polyhydroxystearic Acid, *Punica Granatum (Pomegranate) Extract, Stearic Acid, Tetrasodium Glutamate Diacetate, *Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum. *Denotes organic ingredients
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. • Higher SPF gives more sunburn protection. • Retains SPF after 80 minutes of swimming or sweating. • 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.Mineral Sunscreen SPF-30 TITANIUM DIOXIDE, ZINC OXIDE ALOE VERA LEAF WATER GREEN TEA LEAF MEDIUM-CHAIN TRIGLYCERIDES CAPRYLYL/CAPRYL OLIGOGLUCOSIDE SAFFLOWER ETHYLHEXYLGLYCERIN GLYCERIN GLYCERYL STEARATE CITRATE HELIANTHUS ANNUUS FLOWERING TOP PHENOXYETHANOL PUNICA GRANATUM ROOT BARK STEARIC ACID TETRASODIUM GLUTAMATE DIACETATE COCOA TOCOPHEROL XANTHAN GUM TITANIUM DIOXIDE TITANIUM DIOXIDE 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.Package Labeling: Bottle
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
Other Information • Protect the product in this container from excessive heat and direct sun.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use: On damaged or broken skin.
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.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and consult your doctor if a rash or irritation occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product: • Keep out of eyes. • Rinse with water to remove.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
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 consult your doctor if a rash or irritation occurs. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If pregnant or breast-feeding, ask a health professional before use.
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