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| Product NDC Code | 83108-010 | ||||||
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| Drug Name | Beautiful skin superfluid broad spectrum spf30 m1 |
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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 | EMULSION | ||||||
| Application Number | M020 | ||||||
| Labeler Name | Rationale Group 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.Active Ingredient Zinc Oxide 16.9% 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.DirectionsMM Apply liberally 15 minutes before sun exposure. Reapply At least every 2 hours Use a water resistant sunscreen if swimming or sweating. 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: Sun Protection Measures. 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 Undecane, Aqua (Water), Coco-Caprylate, Caprylic/Capric Triglyceride, Tridecane, Butyloctyl Salicylate, Lauryl PEG-10 Tris (Trimethylsiloxy) silylethyl Dimethicone, Polyhydroxystearic Acid, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Triacontanyl PVP, Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Pentylene Glycol, Ethylhexyl Methoxycrylene, Sodium Palmitoyl Proline, Propanediol, CI 77891 (Titanium Dioxide), Silica, Butylene Glycol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Boron Nitride, Sodium Chloride, Polyurethane-79, Polyurethane-62, Isopropyl Palmitate, Mica, Bisabolol, 1,2-Hexanediol, Sodium Potassium Aluminum Silicate, Limonene, Panthenol, Lecithin, Tocopherol, C12-15 Alkyl Benzoate, Citrus Aurantium Dulcis (Orange) Oil, Caprylhydroxamic Acid, Trideceth-10, CI 77492 (Iron Oxides), Tin Oxide, Citrus Aurantium Bergamia (Bergamot) Leaf Oil, Juniperus Mexicana Oil, Pelargonium Graveolens Oil, Citrus Aurantium Amara (Bitter Orange) Flower Oil, Eugenia Caryophyllus (Clove) Leaf Oil, Ceteareth-25, Helianthus Annuus (Sunflower) Seed Oil, Melanin, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Grandis (Grapefruit) Peel Oil, Citrus Limon (Lemon) Peel Oil, Litsea Cubeba Fruit Oil, Citral, CI 77491 (Iron Oxides), Glycerin, Cetyl Alcohol, CI 77499 (Iron Oxides), Triethoxycaprylylsilane, Magnesium Aspartate, Zinc Gluconate, Nymphaea Alba Flower Extract, Linalool, Cyclopentasiloxane, Glycine, Behenic Acid, Ceramide NP, Cholesterol, Ceramide NS, Serine, Glutamic Acid, PEG/PPG-18/18 Dimethicone, Aspartic Acid, Leucine, Ethylhexylglycerin, Ceramide AP, Ceramide EOP, Ceramide EOS, Copper Gluconate, Alanine, Lysine, Arginine, Tyrosine, Phenylalanine, Proline, Threonine, Valine, Isoleucine, Caprooyl Phytosphingosine, Caprooyl Sphingosine, Phenoxyethanol, Sodium Hyaluronate, Histidine, Acetyl Hexapeptide-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.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.Beautiful Skin Superfluid Broad Spectrum SPF30 M1 ZINC OXIDE CITRAL UNDECANE WATER COCO-CAPRYLATE MEDIUM-CHAIN TRIGLYCERIDES TRIDECANE BUTYLOCTYL SALICYLATE ARGAN OIL .ALPHA.-TOCOPHEROL ACETATE TRICONTANYL POVIDONE DIPROPYLENE GLYCOL PENTYLENE GLYCOL ETHYLHEXYL METHOXYCRYLENE SODIUM PALMITOYL PROLINE PROPANEDIOL TITANIUM DIOXIDE SILICON DIOXIDE BUTYLENE GLYCOL BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE BORON NITRIDE SODIUM CHLORIDE POLYURETHANE-62 ISOPROPYL PALMITATE MICA LEVOMENOL 1,2-HEXANEDIOL LIMONENE, (+)- PANTHENOL TOCOPHEROL ALKYL (C12-15) BENZOATE ORANGE OIL, COLD PRESSED CAPRYLHYDROXAMIC ACID TRIDECETH-10 FERRIC OXIDE YELLOW STANNIC OXIDE BERGAMOT OIL JUNIPERUS DEPPEANA WOOD OIL GERANIUM OIL, ALGERIAN TYPE CITRUS AURANTIUM FLOWER OIL CLOVE LEAF OIL CETEARETH-25 SUNFLOWER OIL CITRUS MAXIMA FRUIT RIND OIL LEMON OIL, COLD PRESSED LITSEA OIL FERRIC OXIDE RED GLYCERIN CETYL ALCOHOL FERROSOFERRIC OXIDE TRIETHOXYCAPRYLYLSILANE MAGNESIUM ASPARTATE ZINC GLUCONATE NYMPHAEA ALBA FLOWER LINALOOL, (+/-)- CYCLOMETHICONE 5 GLYCINE BEHENIC ACID CERAMIDE NP CHOLESTEROL CERAMIDE NG SERINE GLUTAMIC ACID PEG/PPG-18/18 DIMETHICONE ASPARTIC ACID LEUCINE ETHYLHEXYLGLYCERIN CERAMIDE AP CERAMIDE EOS COPPER GLUCONATE ALANINE LYSINE ARGININE TYROSINE PHENYLALANINE PROLINE THREONINE VALINE ISOLEUCINE CAPROOYL PHYTOSPHINGOSINE N-HEXANOYLSPHINGOSINE PHENOXYETHANOL HYALURONATE SODIUM HISTIDINE ACETYL HEXAPEPTIDE-1 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:30ml Label M1
Package Labeling:3ml Outer Package Inner Package
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 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 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