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Product NDC Code | 76147-233 | ||||
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Drug Name | Strivectin advanced spf full screen vanishing tint |
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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 | LOTION | ||||
Application Number | M020 | ||||
Labeler Name | StriVectin Operating Company, Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.ACTIVE INGREDIENTS ZINC OXIDE 16%
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), Dimethicone, Butyloctyl Salicylate, Glycerin, Diisobutyl Adipate, Glyceryl Stearate, Ethylhexyl Methoxycrylene, PEG-100 Stearate, Fragrance (Parfum), Potassium Cetyl Phosphate, Myristyl Nicotinate, Hydrogenated Palm Glycerides, Cocos Nucifera (Coconut) Oil, VP/Hexadecene Copolymer, Triceteareth-4 Phosphate, Glycine Soja (Soybean) Oil, Brassica Campestris (Rapeseed) Seed Oil, Polysilicone-11, Caprylyl Glycol, Tocopherol, Argania Spinosa (Argan) Kernel Oil, Bis(Cyano Butylacetate) Anthracenediylidene, Butyrospermum Parkii (Shea) Butter, Elaeis Guineensis (Palm) Butter, Triethoxycaprylylsilane, Phenoxyethanol, Polyglyceryl-3 Diisostearate, Quercus Suber Bark Extract, Xanthan Gum, Glycyrrhiza Glabra (Licorice) Root Extract, Hexylene Glycol, Oryza Sativa (Rice) Extract, Oryza Sativa (Rice) Germ Extract, Disodium EDTA, Oak Root Extract, Simmondsia Chinensis (Jojoba) Seed Oil, Althaea Officinalis Root Extract, Oryza Sativa (Rice) Bran Extract, Retinyl Palmitate, 7-Dehydrocholesterol, Ascorbyl Palmitate, Bisabolol, Citric Acid, Curcuma Longa (Turmeric) Root Extract, Limonene, Citral, Linalool, Iron Oxides (CI 77491), Iron Oxides (CI 77492), Iron Oxides (CI 77499)
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 Advanced SPF Full Screen Vanishing Tint ZINC OXIDE WATER DIMETHICONE BUTYLOCTYL SALICYLATE GLYCERIN DIISOBUTYL ADIPATE ETHYLHEXYL METHOXYCRYLENE GLYCERYL STEARATE/PEG-100 STEARATE POTASSIUM CETYL PHOSPHATE MYRISTYL NICOTINATE HYDROGENATED PALM GLYCERIDES COCONUT OIL VINYLPYRROLIDONE/HEXADECENE COPOLYMER TRICETEARETH-4 PHOSPHATE SOYBEAN OIL CANOLA OIL DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CAPRYLYL GLYCOL TOCOPHEROL ARGAN OIL CYANOMETHYLACETATE SHEA BUTTER ELAEIS GUINEENSIS FRUIT BUTTER TRIETHOXYCAPRYLYLSILANE PHENOXYETHANOL POLYGLYCERYL-3 DIISOSTEARATE QUERCUS SUBER BARK XANTHAN GUM GLYCYRRHIZA GLABRA HEXYLENE GLYCOL ORYZA SATIVA WHOLE EDETATE DISODIUM QUERCUS PETRAEA WHOLE JOJOBA OIL ALTHAEA OFFICINALIS ROOT VITAMIN A PALMITATE 7-DEHYDROCHOLESTEROL ASCORBYL PALMITATE .ALPHA.-BISABOLOL, (+)- ANHYDROUS CITRIC ACID CURCUMA LONGA WHOLE LIMONENE, (+)- CITRAL FERRIC OXIDE RED FERROSOFERRIC OXIDE FERRIC OXIDE YELLOW 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.01b UC_Adv SPF Full Screen_Tinted
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.
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