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| Product NDC Code | 75936-363 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | 100% mineral broad spectrum sunscreen spf 30 |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | LOTION | ||||||
| Application Number | part352 | ||||||
| Labeler Name | Supergoop 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 Purpose Zinc Oxide 16% 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 generously and evenly 15 minutes before sun exposure reapply after80 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 sub and other sun protection measures 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: Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Arachidyl Alcohol, Arachidyl Glucoside, Astrocaryum Vulgare Kernel Oil, Behenyl Alcohol, Bisabolol, Butyloctyl Salicylate, C13-14 Alkane, Caprylhydroxamic Acid, Caprylic/Capric Triglyceride, Capryloyl Glycerin/Sebacic Acid Copolymer, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid, Coco-Glucosde, Diheptyl Succinate, Erythritol, Ethyl Ferulate, Glycerin, Haematococcus Pluvialis Extract, Jojoba Esters, Lauryl Laurate, Methyl dihydroabietate, Microcrystalline Cellulose, Neopentyl Glycol Diheptanoate, Polyester-7, Polyester-8, Polyhydroxystearic Acid, Propanediol, Sea Water, Sodium Gluconate, Sodium Stearoyl Glutamate, Tocopherol, 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 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 skincancer and early skin aging caused by the sun
Spl product data elements
Usually a list of ingredients in a drug product.100% Mineral Broad Spectrum Sunscreen SPF 30 Titanium Dioxide, Zinc Oxide ARACHIDYL ALCOHOL DOCOSANOL BUTYLOCTYL SALICYLATE SODIUM GLUCONATE COCO GLUCOSIDE ETHYL FERULATE HAEMATOCOCCUS PLUVIALIS METHYL DIHYDROABIETATE MICROCRYSTALLINE CELLULOSE NEOPENTYL GLYCOL DIHEPTANOATE POLYESTER-7 POLYHYDROXYSTEARIC ACID (2300 MW) SODIUM STEAROYL GLUTAMATE PROPANEDIOL SODIUM CHLORIDE CITRIC ACID MONOHYDRATE WATER TOCOPHEROL CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) DIHEPTYL SUCCINATE CETYL ALCOHOL GLYCERIN POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) MEDIUM-CHAIN TRIGLYCERIDES ASTROCARYUM VULGARE KERNEL OIL CAPRYLHYDROXAMIC ACID LEVOMENOL ERYTHRITOL LAURYL LAURATE CAPRYLYL GLYCOL CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED CETOSTEARYL ALCOHOL ARACHIDYL GLUCOSIDE ZINC OXIDE ZINC OXIDE
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 Lotion With Green Algae Broad Spectrum Sunscreen SPF 30 Water Resistant (80 minutes) 3.4 fl. oz. / 100 ml. 100% mineral Lotion SPF 30 tube
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 Do not use on damaged or broken skin When using this product keep out of eyes Rinse with water to remove. If product is swallowed, get medical help or contact a Poison Control 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