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| Product NDC Code | 44717-072 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Premium moisturizing sunscreen broad spectrum spf 15 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | Wasatch Product Development, 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.Active ingredients Avobenzone 2%, Homosalate 5%, Octisalate 2%, Octocrylene 10% 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.Directions shake well before use apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours. children under 6 months of age: ask a doctor. 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 your time in the sun, especially from 10a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, butyloctyl salicylate, hydrated silica, styrene/acrylates copolymer, VP/hexadecene copolymer, polyester-8, dimethicone, caprylyl methicone, ethylhexyl stearate, trideceth-6, glyceryl stearate, PEG-100 stearate, fragrance, sodium polyacrylate, behenyl alcohol, dimethyl capramide, ethylhexylglycerin, trimethylsiloxysilicate, xanthan gum, polyaminopropyl biguanide, tocopheryl acetate, BHT, disodium EDTA, methylisothiazolinone
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.Stop use and ask a doctor if rash occurs
Purpose
Information about the drug product’s indications for 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.
Spl product data elements
Usually a list of ingredients in a drug product.Premium Moisturizing Sunscreen Broad Spectrum SPF 15 Avobenzone, Homosalate, Octisalate, Octocrylene POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) EDETATE DISODIUM ANHYDROUS BUTYLOCTYL SALICYLATE DIMETHYL CAPRAMIDE XANTHAN GUM .ALPHA.-TOCOPHEROL ACETATE TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) BUTYLATED HYDROXYTOLUENE METHYLISOTHIAZOLINONE VINYLPYRROLIDONE/HEXADECENE COPOLYMER OCTOCRYLENE OCTOCRYLENE DIMETHICONE 100 CAPRYLYL TRISILOXANE TRIDECETH-6 GLYCERYL MONOSTEARATE HYDRATED SILICA PEG-100 STEARATE SODIUM POLYACRYLATE (2500000 MW) DOCOSANOL ETHYLHEXYLGLYCERIN POLYAMINOPROPYL BIGUANIDE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE WATER ETHYLHEXYL STEARATE
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.Sun Bum 15 Premium Moisturizing Sunscreen Lotion Broad Spectrum SPF 15 Water Resistant (80 Minutes) Gluten Free and Vegan Antioxidant Enriched (Vitamin E) Dermatologist Tested 6 FL OZ / 177 mL Moist sunscreen lotion SPF 15
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 immediately.
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
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 Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove
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