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Mineral spf starter kit - Medication Information

Product NDC Code 75936-610
Drug Name

Mineral spf starter kit

Type Brand
Dosage Form KIT
Application Number M020
Labeler Name Supergoop, LLC
Packages
Package NDC Code Description
75936-610-01 1 kit in 1 kit (75936-610-01) * 15 ml in 1 tube (75936-612-01) * 30 ml in 1 tube (75936-613-01) * 15 ml in 1 tube (75936-611-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Mineral Sheerscreen SPF 30 Active Ingredients Zinc Oxide 17.5% Sunscreen Mineral Mattescreen SPF 40 Active Ingredient Titanium Dioxide 1.3% Sunscreen Zinc Oxide 17.4% Sunscreen Play Mineral Lotion SPF 30 Active Ingredients 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.
Mineral Sheerscreen SPF 30 Apply generously and evenly as the last step in your skincare routine, before makeup and 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor Mineral Mattescreen SPF 40 Directions Apply generously and evenly as the last step in your skincare routine, before makeup and 15 minutes before sun exposure. Reapply at least every 2 hours. Use a water resistant sunscreen if swimming or sweating. 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 10 a.m.- 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor Play 100% Mineral Lotion SPF 30 Directions • apply generously and evenly 15 minutes before sun exposure • reapply: • after 80 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 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.
Mineral Sheerscreen SPF 30 Inactive Ingredients: Water, Isododecane, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Propanediol, Glycerin, Squalane, Trioctyldodecyl Citrate, Polyglycerin-3, Polyglyceryl-3 Lactate/Laurate, Polysilicone-11, Cetearyl Alcohol, Glyceryl Stearate, Sodium Stearoyl Glutamate, Butylene Glycol, Xanthan Gum, Polyacrylate Crosspolymer-6, Isostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylhydroxamic Acid, Citric Acid, Aloe Barbadensis Leaf Juice, Lespedeza Capitata Leaf/Stem Extract, Maltodextrin, Sodium Hyaluronate Mineral Mattescreen SPF 40 Inactive Ingredients: Dimethicone, Dimethicone Crosspolymer, Caprylic/Capric Triglyceride, Methyl Dihydroabietate, Polyhydroxystearic Acid, C9-12 Alkane, Glycerin, Iron Oxides (CI 77492), Ethylhexylglycerin, Water (Aqua), Coco-Caprylate/Caprate, Silica, Stearic Acid, Iron Oxides (CI 77491), Iron Oxides (CI 77499), Hedychium Coronarium Root Extract, Lactobacillus/Arundinaria Gigantea Leaf Ferment Filtrate, Leuconostoc/Radish Root Ferment Filtrate, Titanium Dioxide (CI 77891) Play 100% Mineral Lotion SPF 30 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-Glucoside, 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), decrease 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 SPF Starter Kit Titanium Dioxide, Zinc Oxide Mineral Sheerscreen SPF 30 Zinc Oxide WATER SQUALANE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) HYALURONATE SODIUM CETOSTEARYL ALCOHOL XANTHAN GUM CAPRYLHYDROXAMIC ACID ALOE VERA LEAF GLYCERIN MALTODEXTRIN POLYHYDROXYSTEARIC ACID (2300 MW) POLYGLYCERYL-3 PENTARICINOLEATE LESPEDEZA CAPITATA FLOWERING TOP PROPANEDIOL POLYGLYCERIN-3 POLYGLYCERYL-3 LAURATE MEDIUM-CHAIN TRIGLYCERIDES BUTYLOCTYL SALICYLATE LECITHIN, SUNFLOWER ISOSTEARIC ACID CITRIC ACID MONOHYDRATE ISODODECANE SODIUM STEAROYL GLUTAMATE BUTYLENE GLYCOL GLYCERYL MONOSTEARATE ZINC OXIDE ZINC OXIDE SODIUM CHLORIDE AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) TRIOCTYLDODECYL CITRATE Mineral Mattescreen SPF 40 Titanium Dioxide, Zinc Oxide STEARIC ACID FERRIC OXIDE YELLOW FERRIC OXIDE RED GLYCERIN COCO-CAPRYLATE/CAPRATE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE C9-11 ALKANE/CYCLOALKANE WATER ARUNDINARIA GIGANTEA WHOLE DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) DIMETHICONE POLYHYDROXYSTEARIC ACID (2300 MW) ETHYLHEXYLGLYCERIN MEDIUM-CHAIN TRIGLYCERIDES METHYL DIHYDROABIETATE TOCOPHEROL FERROSOFERRIC OXIDE HEDYCHIUM CORONARIUM ROOT LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE Mineral Broad Spectrum Sunscreen Zinc Oxide SODIUM CHLORIDE COCO GLUCOSIDE ERYTHRITOL GLYCERIN SODIUM STEAROYL GLUTAMATE CITRIC ACID MONOHYDRATE DOCOSANOL ARACHIDYL ALCOHOL ARACHIDYL GLUCOSIDE LEVOMENOL CAPRYLHYDROXAMIC ACID TOCOPHEROL DIHEPTYL SUCCINATE POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) POLYHYDROXYSTEARIC ACID (2300 MW) PROPANEDIOL POLYESTER-7 ZINC OXIDE ZINC OXIDE POTASSIUM HYDROLYZED JOJOBA ESTERS ETHYL FERULATE HAEMATOCOCCUS PLUVIALIS NEOPENTYL GLYCOL DIHEPTANOATE MICROCRYSTALLINE CELLULOSE SODIUM GLUCONATE CETOSTEARYL ALCOHOL C13-15 ALKANE WATER CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) CAPRYLYL GLYCOL CETYL ALCOHOL LAURYL LAURATE METHYL DIHYDROABIETATE ASTROCARYUM VULGARE KERNEL OIL BUTYLOCTYL SALICYLATE MEDIUM-CHAIN TRIGLYCERIDES CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED

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! 100% Mineral SPF Starter Kit Protect sensitive skin with 100% mineral SPF favorites for face & body belly band

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.

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