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| Product NDC Code | 10596-805 | ||||
|---|---|---|---|---|---|
| Drug Name | Hello sunday the shimmer one mineral glow spf 45 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | STICK | ||||
| Application Number | M020 | ||||
| Labeler Name | Kao USA Inc. | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients ZINC OXIDE 21.73%
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 Twist the shimmer stick up slightly so that the stick is above the base, remove the plastic dust cap, and twist the shimmer stick back down for optimal usage. Swipe generously on dry face & body, then blend in for a subtle glow. Use over any other Hello Sunday SPF product and as the last step in your skincare routine (under or over makeup) 15 minutes before sun exposure. Reapply SPF protection 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 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. 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.Ingredients C12-15 ALKYL BENZOATE, CAPRYLIC/CAPRIC TRIGLYCERIDE, ISOSTEARYL ISOSTEARATE, HELIANTHUS ANNUUS (SUNFLOWER) SEED WAX, OCTYLDODECANOL, BUTYLOCTYL SALICYLATE, TRIBEHENIN, DIISOSTEARYL MALATE, MICA, SILICA, POLYHYDROXYSTEARIC ACID, STEARALKONIUM BENTONITE, CALCIUM ALUMINUM BOROSILICATE, SODIUM HYALURONATE, GLYCINE SOJA (SOYBEAN) OIL, TETRAHEXYLDECYL ASCORBATE, ORYZA SATIVA (RICE) GERM EXTRACT, ORYZA SATIVA (RICE) EXTRACT, ETHYLHEXYL PALMITATE, MALIC ACID, TOCOPHEROL, PHYSALIS ANGULATA EXTRACT, ISOSTEARIC ACID, LECITHIN, POLYGLYCERYL-3 POLYRICINOLEATE, CAPRYLYL GLYCOL, BENZOTRIAZOLYL DODECYL P-CRESOL, PROPYLENE CARBONATE, POLYGLYCERYL-3 DIISOSTEARATE, TIN OXIDE, TRIHYDROXYSTEARIN, GLUCOMANNAN, TITANIUM DIOXIDE (CI 77891), IRON OXIDES (CI 77491)
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 ageing 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.Hello Sunday The Shimmer One Mineral Glow SPF 45 Zinc Oxide ISOSTEARYL ISOSTEARATE HYALURONATE SODIUM RICE GERM HELIANTHUS ANNUUS SEED WAX TRIHYDROXYSTEARIN TETRAHEXYLDECYL ASCORBATE OCTYLDODECANOL BUTYLOCTYL SALICYLATE TRIBEHENIN DIISOSTEARYL MALATE TOCOPHEROL MICA ALKYL (C12-15) BENZOATE SILICON DIOXIDE POLYHYDROXYSTEARIC ACID (2300 MW) CALCIUM ALUMINUM BOROSILICATE ETHYLHEXYL PALMITATE MALIC ACID KONJAC MANNAN PHYSALIS ANGULATA WHOLE CAPRYLYL GLYCOL ZINC OXIDE ZINC OXIDE ISOSTEARIC ACID POLYGLYCERYL-3 DIISOSTEARATE LECITHIN, SOYBEAN MEDIUM-CHAIN TRIGLYCERIDES SOYBEAN OIL STANNOUS OXIDE TITANIUM DIOXIDE FERRIC OXIDE RED BENZOTRIAZOLYL DODECYL P-CRESOL PROPYLENE CARBONATE POLYGLYCERYL-3 PENTARICINOLEATE
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.Product Packaging 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
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 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 Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water to remove. Keep out of reach of children. If 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