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| Product NDC Code | 83836-013 | ||||
|---|---|---|---|---|---|
| Drug Name | Rain skincare mineral facial sunscreen |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | CREAM | ||||
| Application Number | M020 | ||||
| Labeler Name | Rain Africa Innovations (Pty) 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.Ingredients Aqua (Water), Zinc Oxide , Caprylic/Capric Triglyceride, Glycerin, Aloe Ferox Leaf Extract, Polyhydroxystearic Acid, Polysorbate 20, Silica, Glyceryl Stearate Citrate, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Benzyl Alcohol, Daucus Carota Sativa (Carrot) Seed Oil, Glyceryl Caprylate, Bentonite, C13-15 Alkane, Coco-Caprylate/Caprate, Squalane, Glyceryl Stearate, Cetyl Alcohol, Levulinic Acid, Sodium Levulinate, Cellulose Gum, Tocopherol, Xanthan Gum, Hydrolyzed Jojoba Esters, Dehydroacetic Acid, Sodium Hyaluronate, Citric Acid, Potassium Sorbate, Sodium Benzoate, Limonene, Linalool.
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.Apply a generous amount at least 15 minutes before sun exposure; reapply at least every 2 hours.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Aqua (Water), Zinc Oxide, Caprylic/Capric Triglyceride, Glycerin, Aloe Ferox Leaf Extract, Polyhydroxystearic Acid, Polysorbate 20, Silica, Glyceryl Stearate Citrate, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Benzyl Alcohol, Daucus Carota Sativa (Carrot) Seed Oil, Glyceryl Caprylate, Bentonite, C13-15 Alkane, Coco-Caprylate/Caprate, Squalane, Glyceryl Stearate, Cetyl Alcohol, Levulinic Acid, Sodium Levulinate, Cellulose Gum, Tocopherol, Xanthan Gum, Hydrolyzed Jojoba Esters, Dehydroacetic Acid, Sodium Hyaluronate, Citric Acid, Potassium Sorbate, Sodium Benzoate, Limonene, Linalool 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. Helps prevent sunburn
Purpose
Information about the drug product’s indications for use.Helps prevent sunburn
Spl product data elements
Usually a list of ingredients in a drug product.Rain Skincare Mineral Facial Sunscreen Zinc Oxide GLYCERYL STEARATE CITRATE BENZYL ALCOHOL CARROT SEED OIL CETOSTEARYL ALCOHOL WATER GLYCERYL CAPRYLATE COCO-CAPRYLATE/CAPRATE GLYCERYL STEARATE SE HYDROLYZED JOJOBA ESTERS (ACID FORM) DEHYDROACETIC ACID MEDIUM-CHAIN TRIGLYCERIDES GLYCERIN SODIUM BENZOATE CETYL ALCOHOL TOCOPHEROL SILICON DIOXIDE ALOE FEROX LEAF POLYHYDROXYSTEARIC ACID (2300 MW) ZINC OXIDE ZINC OXIDE POLYSORBATE 20 SORBITAN OLIVATE CARBOXYMETHYLCELLULOSE SODIUM C13-15 ALKANE HYALURONATE SODIUM XANTHAN GUM LEVULINIC ACID CETEARYL OLIVATE BENTONITE SQUALANE SODIUM LEVULINATE CITRIC ACID MONOHYDRATE POTASSIUM SORBATE
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.Mineral Facial Sunscreen SPF 40 High Protection Broad Spectrum UVB/UVA Mineral Facial Sunscreen
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.For children under 6 months of age: consult a doctor. Stop use and consult a doctor if rash occurs.
Instructions for use
Information about safe handling and use of the drug product.Directions: Apply a generous amount at least 15 minutes before sun exposure; reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. Apply a generous amount at least 15 minutes before sun exposure; reapply at least every 2 hours.
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
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin ageing. 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.-2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses
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 a doctor if rash occurs.
Storage and handling
Information about safe storage and handling of the drug product.Store below 25℃ away from 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: Keep out of reach of children For children under 6 months of age: consult a doctor. If swallowed, get medical help or contact a Poison Control Center right away. Do not use on damaged or broken skin. Keep out of eyes. Rinse with water to remove. Stop use and consult a doctor if rash occurs. Keep out of reach of children Stop use and consult a doctor if rash occurs. For children under 6 months of age: consult a doctor. Stop use and consult 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