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| Product NDC Code | 51417-0002 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Clean screen mineral spf30 mattifying face sunscreen broad spectrum |
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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 | M020 | ||||||
| Labeler Name | REN Ltd | ||||||
| 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 22% 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 Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating 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 value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2p.m. Wear long-sleeved 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 Aqua (Water), Caprylic/Capric Triglyceride, Aloe Barbadensis Leaf Juice, Glycerin, Caprylyl Caprylate/Caprate, Propanediol, Arachidyl Alcohol, Cetearyl Alcohol, Coco-Glucoside, Oryza Sativa Starch, Pongamia Glabra Seed Oil, Microcrystalline Cellulose, Behenyl Alcohol, Phenoxyethanol, Arachidyl Glucoside, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Passiflora Edulis Fruit Extract, Ethylhexylglycerin, Glyceryl Oleate, Vaccinium Macrocarpon (Cranberry) Seed Oil, Xanthan Gum, Cellulose Gum, Sodium Chloride, HippophaeRhamnoides Oil, Citrus Nobilis (Mandarin Orange) Peel Oil, Anthemis Nobilis Flower Oil, Cinnamomum Camphora Linalloliferum Wood Oil, Pelargonium Graveolens Flower Oil, Glucose, Parfum* (Fragrance), Helianthus Annuus (Sunflower) Seed Oil, Tocopherol, Rosmarinus Officinalis (Rosmary) Leaf Extract, Hydrogenated Palm Glycerides Citrate, Citric Acid, Sodium Hydroxide, Citronellol, Geraniol, Limonene, Linalool *100% Natural Fragrance - Parfum 100% Naturel
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 ), decreases the risk of sin cancer and early skin aging caused by the sun. Directions
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.Clean Screen Mineral SPF30 Mattifying Face Sunscreen Broad Spectrum ZINC OXIDE WATER MEDIUM-CHAIN TRIGLYCERIDES ALOE VERA LEAF GLYCERIN CAPRYLYL CAPRYLATE/CAPRATE PROPANEDIOL ARACHIDYL ALCOHOL CETOSTEARYL ALCOHOL COCO GLUCOSIDE STARCH, RICE KARUM SEED OIL MICROCRYSTALLINE CELLULOSE DOCOSANOL PHENOXYETHANOL ARACHIDYL GLUCOSIDE ISOSTEARIC ACID ETHYLHEXYLGLYCERIN GLYCERYL OLEATE CRANBERRY SEED OIL XANTHAN GUM CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM SODIUM CHLORIDE MANDARIN OIL CHAMAEMELUM NOBILE FLOWER OIL PELARGONIUM GRAVEOLENS FLOWER OIL ANHYDROUS DEXTROSE SUNFLOWER OIL TOCOPHEROL CITRIC ACID MONOHYDRATE SODIUM HYDROXIDE LINALOOL, (+/-)- 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: (51417-0002-5) 3 4
Package Labeling: (51417-0002-1) 1 2
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 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? please contact 732-553-1185 from 8:30-17:30 EST
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 ask a doctor if Rash 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.
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 swallowed, get medical help or contact 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