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Product NDC Code | 70157-369 | ||||||
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Drug Name | Sunceutical spf 50 mineral face cream |
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Type | Brand | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | CREAM | ||||||
Application Number | M020 | ||||||
Labeler Name | Baxter Laboratories Pty. Ltd. | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Purpose Zinc Oxide 20%...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 Children under 6 months of age: Ask a doctor 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. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Water, Coco-Caprylate/Caprate, Isohexadecane, Caprylic/Capric Triglyceride, Coco-Caprylate, Polyglyceryl-2 Dipolyhydroxystearate, Isoamyl Laurate, Pentylene Glycol, Isododecane, Polyglyceryl-3 Polyricinoleate, Glyceryl Polymethacrylate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Magnesium Sulfate, Niacinamide, Polyhyroxystearic Acid, Saccharide Isomerate, Isostearic Acid, Fragrance, Disteardimonium Hectorite, Hydroxyacetophenone, Propylene Glycol, Pongamia Pinnata Seed Extract, Propylene Carbonate, Iron oxides, Limonene, Citric Acid, Sodium Citrate, Linalool, Palmitoyl Tripeptide-1
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.Stop use and ask a doctor if rash occurs
Purpose
Information about the drug product’s indications for 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
Spl product data elements
Usually a list of ingredients in a drug product.Sunceutical SPF 50 Mineral Face Cream Zinc Oxide ZINC OXIDE ZINC OXIDE WATER HYDROXYACETOPHENONE CAPRYLIC/CAPRIC TRIGLYCERIDE ISOAMYL LAURATE COCO-CAPRYLATE PENTYLENE GLYCOL DISTEARDIMONIUM HECTORITE ISODODECANE GLYCERYL POLYMETHACRYLATE (300000 MPA.S) ISOHEXADECANE POLYGLYCERYL-2 DIPOLYHYDROXYSTEARATE MAGNESIUM SULFATE LINALOOL PALMITOYL TRIPEPTIDE-1 POLYGLYCERYL-3 DIISOSTEARATE POLYGLYCERYL-3 PENTARICINOLEATE CITRIC ACID SODIUM CITRATE PROPYLENE GLYCOL SORBITAN OLIVATE NIACINAMIDE ISOSTEARIC ACID LIMONENE, (+)- POLYHYDROXYSTEARIC ACID (2300 MW) SACCHARIDE ISOMERATE PONGAMIA PINNATA SEED PROPYLENE CARBONATE COCO-CAPRYLATE/CAPRATE IRON OXIDES
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.Emma Lewisham Sunceutical SPF 50 Mineral Face Cream Zinc Oxide Mineral Sun-Active Broad Spectrum SPF 50 Sunscreen 50mL/ 1.7 FL. OZ. Mineral Face cream main 12 2024 sunceutical SPF 50 Mineral Face Cream refill
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information Protect the product in this container 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.
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