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| Product NDC Code | 76147-235 | ||||||||
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| Drug Name | Strivectin multi-action super-c spf 30 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | StriVectin Operating Company, Inc. | ||||||||
| 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 Avobenzone 3.0% Homosalate 7.0% Octisalate 4.5% Octocrylene 10%
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 generously 15 minutes before sun exposure and as needed reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time inthe sun increases your risk of skin cancer andearly skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPFvalue of 15 or higher and other sun protectionmeasures 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.INACTIVE INGREDIENTS Aqua/Water/Eau, Propanediol, Dimethicone, Cetearyl Alcohol, Potassium Cetyl Phosphate, Tetrahexyldecyl Ascorbate, Ergothioneine, Mannitol, Bacillus/Sea Salt, Ferment Filtrate, Myristyl Nicotinate, Citrus Japonica Fruit Extract, Oryza Sativa (Rice) Germ Extract, Morinda Citrifolia Extract, Oryza Sativa (Rice) Extract, Glycerin,Glycerin Soja (Soybean) Oil, Tocopheryl Acetate, Cetearyl Glucoside, Lecithin, Ubiquinone, Butylene Glycol, 1,2 Hexanediol, Decyl Glucoside, Hexylene Gkycik, CaprylylGlycol, Polysilicon-11, Polyglyceritl-3 Diisostearate, Acrylates/C 10-30Alkyl Acrylate Crosspolymer, Sodium Acrylates Copolymer, Caprylhydroamic Acid, Aminomethyl Propanol, Disodium EDTA, Fragrance/Parfum, Phenoxyethanol, Sodium Benzoate, Citric Acid, Limonene, Linalool, Benzyl Benzoate, Geraniol, Citral, Yellow 5 (CI 19140), Red 40 (CI 16035), [ILN 60988]
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 aging 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.StriVectin multi-action Super-C SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE WATER PROPANEDIOL DIMETHICONE STEARYL ALCOHOL CETYL ALCOHOL POTASSIUM CETYL PHOSPHATE TETRAHEXYLDECYL ASCORBATE ERGOTHIONEINE MANNITOL SEA SALT MYRISTYL NICOTINATE CITRUS JAPONICA FRUIT RICE GERM NONI FRUIT RICE OIL GLYCERIN SOYBEAN OIL .ALPHA.-TOCOPHEROL ACETATE CETEARYL GLUCOSIDE LECITHIN, SOYBEAN UBIQUINOL BUTYLENE GLYCOL 1,2-HEXANEDIOL DECYL GLUCOSIDE HEXYLENE GLYCOL CAPRYLYL GLYCOL POLYSILICONE-15 POLYGLYCERYL-3 DIISOSTEARATE ACRYLATES CROSSPOLYMER-6 SODIUM ACRYLATE CAPRYLHYDROXAMIC ACID AMINOMETHYL PROPANEDIOL DISODIUM EDTA-COPPER PHENOXYETHANOL SODIUM BENZOATE CITRIC ACID ACETATE LIMONENE, (+)- LINALOOL, (+)- BENZYL BENZOATE GERANIOL CITRAL FD&C YELLOW NO. 5 FD&C RED NO. 40 AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE
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.Super-C SPF 30 50mL. Super-C SPF 30 50mL. Super-C SPF 30 50mL
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.
Storage and handling
Information about safe storage and handling of the drug product.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. 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