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| Product NDC Code | 69219-108 | ||||||||||||
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| Drug Name | Extreme protect spf 40 all shades |
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| Type | Brand | ||||||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||||||
| Dosage Form | CREAM | ||||||||||||
| Application Number | M020 | ||||||||||||
| Labeler Name | Science of Skincare, LLC. | ||||||||||||
| 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.Zinc Oxide: 15.3% Titanium Dioxide: 1.3%
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.Apply liberally 15 minutes before sun exposure. Reapply: After 40 minutes of swimming or sweating Immediately after towel drying At least 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 value of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10am - 2pm. wear long-sleeve shirts, pants, hats, and sunglasses.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water/Aqua/Eau, Zinc Oxide, C12-15 Alkyl Benzoate, Glycerin, Caprylic Capric Triglycerides, Tocopherol, Sorbitan Stearate, Panthenyl Triacetate, Titanium Dioxide, Pentylene Glycol, Ethyl Linoleate, Polyhydroxystearic Acid, Tribehenin, Polyurethane-62, Ethylhexylglycerin, Polyglyceryl-4 Isostearate, Hexyl Laurate, Cetyl PEG/PPG-10/1 Dimethicone, Butylene Glycol, Oleyl Alcohol, Xanthan Gum, Aluminum Stearate, Propylene Glycol, Asiaticoside, Asiatic Acid, Madecassic Acid, Alumina, Olea Europaea (Olive) Leaf Extract, Sorbitol/Sebacic Acid Copolymer Behenate, Magnesium Aluminum Silicate, Trideceth-6, Phenoxyethanol, Aloe Barbadensis Leaf Juice, Isostearic Acid, Disodium EDTA, Polyquaternium-7, +/- CI 77491, CI 77492, CI 77499 *May contain one or more of these ingredients
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.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.Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Extreme Protect SPF 40 All Shades Zinc Oxide, Titanium Dioxide TITANIUM DIOXIDE TITANIUM DIOXIDE ETHYLHEXYLGLYCERIN ALOE VERA LEAF POLYURETHANE-34 (40 MPA, TENSILE STRENGTH OF FILM AT BREAK) WATER CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) XANTHAN GUM PHENOXYETHANOL ISOSTEARIC ACID EDETATE DISODIUM FERRIC OXIDE RED POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) GLYCERIN MAGNESIUM ALUMINUM SILICATE OLEYL ALCOHOL MADECASSIC ACID DIMETHICONE 100 FERRIC OXIDE YELLOW CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) FERROSOFERRIC OXIDE PANTHENOL TRIACETATE, (+)- ETHYL LINOLEATE ASIATICOSIDE ALKYL (C12-15) BENZOATE MEDIUM-CHAIN TRIGLYCERIDES TOCOPHEROL SORBITAN MONOSTEARATE HEXYL LAURATE BUTYLENE GLYCOL PENTYLENE GLYCOL POLYGLYCERYL-4 ISOSTEARATE ALUMINUM STEARATE ALUMINUM OXIDE TRIDECETH-6 ZINC OXIDE ZINC OXIDE PROPYLENE GLYCOL ASIATIC ACID TRIBEHENIN OLEA EUROPAEA LEAF POLYHYDROXYSTEARIC ACID (2300 MW)
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.69219-108-21 5g 10 pack 69219-108-01 Bronze 100g bottle 69219-108-11 Beige Box 69219-108-01 Beige 100g bottle 69219-108-01 NT 100g bottle 69219-108-02 5g single 69219-108-11 NT Box 69219-108-11 Bronze 100g box 69219-108-03 69219-108-31
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 product is 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.Protect this product from excessive heat and direct sun.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Call Customer Care at (888) 804 - 4447
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.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