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Product NDC Code | 82931-001 | ||||||||
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Drug Name | Sand and sky tinted glow primer spf30 |
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Type | Brand | ||||||||
Active Ingredients |
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Route | TOPICAL | ||||||||
Dosage Form | LOTION | ||||||||
Application Number | part352 | ||||||||
Labeler Name | Supernova USA Inc. | ||||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose Avobenzone 3.0% Sunscreen Homosalate 8.0% Sunscreen Octisalate 4.0% Sunscreen Octocrylene 2.0% 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 daily as the last step in your morning routine on your face, neck and decolletage. Apply liberally and evenly 20 minutes before sun exposure. Layer with additional sunscreen that is water-resistant especially when going outdoor and to the beach. Reapply every 2 hours. 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. - 2. p.m. Wear a long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Aqua / Water / Eau, Aloe Barbadensis Leaf Juice, Cyclopentasiloxane, Isostearyl Neopentanoate, Glycerin, Cyclohexasiloxane, Ceteareth-20, Chondrus Crispus Extract, Cetearyl Alcohol, Prunus Armeniaca Kernel Oil, Panthenyl Triacetate, Hydrolyzed Hyaluronic Acid, Tocopherol, Glycine Soja Oil, Panthenol, Serine, Allantoin, Sodium Hyaluronate Crosspolymer, Sorbitol, Urea, Caprylyl Glycol, Ammonium Acryloyldimethyltaurate / VP Copolymer, Xanthan Gum, PEG-40 Stearate, Triacontanyl PVP, Silica, Cetyl Dimethicone, Ethyl Linoleate, Caprylhydroxamic Acid, Pentylene Glycol, Oleyl Alcohol, Disodium EDTA, Lactic Acid, Fragrance / Parfum, Sodium Lactate, Sodium Chloride, Ethylhexylglycerin, CI 77491, CI 77492, Limonene, Linalool.
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.Active Ingredients Purpose Avobenzone 3.0% Sunscreen Homosalate 8.0% Sunscreen Octisalate 4.0% Sunscreen Octocrylene 2.0% Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.SAND AND SKY TINTED GLOW PRIMER SPF30 Avobenzone, Homosalate, Octisalate, Octocrylene AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE WATER ALOE VERA LEAF CYCLOMETHICONE 5 ISOSTEARYL NEOPENTANOATE GLYCERIN CYCLOMETHICONE 6 POLYOXYL 20 CETOSTEARYL ETHER CHONDRUS CRISPUS CARRAGEENAN CETOSTEARYL ALCOHOL APRICOT KERNEL OIL PANTHENOL TRIACETATE, (+)- HYALURONIC ACID TOCOPHEROL SOYBEAN OIL PANTHENOL SERINE ALLANTOIN HYALURONATE SODIUM SORBITOL UREA CAPRYLYL GLYCOL AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER XANTHAN GUM PEG-40 STEARATE TRICONTANYL POVIDONE SILICON DIOXIDE CETYL DIMETHICONE 25 ETHYL LINOLEATE CAPRYLHYDROXAMIC ACID PENTYLENE GLYCOL OLEYL ALCOHOL EDETATE DISODIUM ANHYDROUS LACTIC ACID, UNSPECIFIED FORM SODIUM LACTATE SODIUM CHLORIDE ETHYLHEXYLGLYCERIN FERRIC OXIDE RED FERRIC OXIDE YELLOW LIMONENE, (+)- LINALOOL, (+/-)- Light pink lotion
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.PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton SAND & SKY Tinted Glow Primer SPF30 Base De Teint Éclat SPF30 Lightweight UVA + UVB Broad Spectrum SPF30 Universal Tint Net 60 mL / 2.03 fl. oz. US SAND & SKY
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.Store below 30°C / 86°F and avoid direct sunlight. 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. When using this product keep out of eyes. Rinse with water to remove.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information Protect the product from excessive heat and direct sun
Questions? Contact (626) 616-5811
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.
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