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Product NDC Code | 75936-510 | ||||
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Drug Name | Mineral sunscreen spf 30 |
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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 | SPRAY | ||||
Application Number | part352 | ||||
Labeler Name | Supergoop, LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Purpose Zinc Oxide 12.0% ..................................... 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 SHAKE WELL to activate. If the mist is clear, keep shaking. Apply liberally 15 minutes before sun exposure Reapply: - after 80 minutes of swimming or sweating - immediately after towel drying - at least every 2 hours whem exposed to sunlight Children un 6 months: 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 time in the sun epsecially from 10 a.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.Aloe Barbadensis Leaf Juice, Bentonite, Butyloctyl Salicylate, Calendula Officinalis Flower Extract, Caprylhydroxamic Acid, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Cetearyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Coco Glucoside, Glycerin, Helianthus Annuus (Sunflower) Seed Oil, Heptyl Undecylenate, Jojoba Esters, Melissa Officinalis Leaf Extract, Methyl Dihydroabietate, Nasturtium Officinale Flower/Leaf Extract, Spiraea Ulmaria Flower Extract, Water
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 is 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.Mineral Sunscreen SPF 30 Zinc Oxide FILIPENDULA ULMARIA ROOT HEPTYL UNDECYLENATE HYDROLYZED JOJOBA ESTERS (ACID FORM) MELISSA OFFICINALIS LEAF METHYL DIHYDROABIETATE NASTURTIUM OFFICINALE FLOWERING TOP FILIPENDULA ULMARIA FLOWER WATER ZINC OXIDE ZINC CATION ALOE VERA LEAF BENTONITE BUTYLOCTYL SALICYLATE CALENDULA OFFICINALIS FLOWER CAPRYLHYDROXAMIC ACID CAPRYLYL GLYCOL GLYCERIN SAFFLOWER OIL CETOSTEARYL ALCOHOL CHAMOMILE COCO GLUCOSIDE SUNFLOWER OIL
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.Supergoop! Play SPF 30 100% Mineral Body Mist with Marigold Extract Broad Spectrum Sunscreen SPF 30 Water Resistant (80 minutes) 6 fl. oz. / 177 mL. Principal Display Panel
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
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 Flammable: Contents under pressure. Do not punture or incinerate. Do not store at temperatures above 120 F. Do not use in the precesne of a flame or spark, or while smoking Do not use on damaged or broken skin When using this product keep out of eyes Rinse with water to remove 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