NDC 82384-0030 Spf Bestsellers Starter Kit

Avobenzone, Homosalate, Octisalate, Octocrylene

NDC Product Code 82384-0030

NDC 82384-0030-1

Package Description: 1 KIT in 1 KIT * 15 mL in 1 BOTTLE (82384-0032-1) * 30 mL in 1 BOTTLE (82384-0033-1) * 15 mL in 1 TUBE (82384-0031-1)

NDC Product Information

Spf Bestsellers Starter Kit with NDC 82384-0030 is a a human over the counter drug product labeled by System Beauty, Llc. The generic name of Spf Bestsellers Starter Kit is avobenzone, homosalate, octisalate, octocrylene. The product's dosage form is kit and is administered via topical form.

Dosage Form: Kit - A packaged collection of related material.

Product Type: Human Otc Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • POLYESTER-7 (UNII: 0841698D2F)
  • NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
  • ZINC SULFATE (UNII: 89DS0H96TB)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • ISODODECANE (UNII: A8289P68Y2)
  • PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
  • SHEA BUTTER (UNII: K49155WL9Y)
  • INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
  • DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)
  • DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • MANNITOL (UNII: 3OWL53L36A)
  • POLYMETHYLSILSESQUIOXANE (11 MICRONS) (UNII: Z570VEV8XK)
  • ISOHEXADECANE (UNII: 918X1OUF1E)
  • MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • LECITHIN, SUNFLOWER (UNII: 834K0WOS5G)
  • DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
  • DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
  • NIACINAMIDE (UNII: 25X51I8RD4)
  • ETHYLHEXYL HYDROXYSTEARATE (UNII: B7I80BVV5E)
  • BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
  • HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
  • CAPRYLYL GLYCOL (UNII: 00YIU5438U)
  • MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
  • LIMONIUM GERBERI WHOLE (UNII: 2J5K7YCF9F)
  • LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)
  • PANTOTHENIC ACID (UNII: 19F5HK2737)
  • TOCOPHEROL (UNII: R0ZB2556P8)
  • SUNFLOWER OIL (UNII: 3W1JG795YI)
  • PROPANEDIOL (UNII: 5965N8W85T)
  • ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
  • POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)
  • CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
  • ISODODECANE (UNII: A8289P68Y2)
  • ARGININE (UNII: 94ZLA3W45F)
  • CETYL PHOSPHATE (UNII: VT07D6X67O)
  • COCO-CAPRYLATE (UNII: 4828G836N6)
  • 1,2-HEXANEDIOL (UNII: TR046Y3K1G)
  • WATER (UNII: 059QF0KO0R)
  • BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
  • ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • COCOA (UNII: D9108TZ9KG)
  • FERULIC ACID (UNII: AVM951ZWST)
  • DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
  • TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)
  • BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
  • MICA (UNII: V8A1AW0880)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
  • LAURYL LACTATE (UNII: G5SU0BFK7O)
  • CHLORPHENESIN (UNII: I670DAL4SZ)
  • HYALURONATE SODIUM (UNII: YSE9PPT4TH)
  • FERRIC OXIDE RED (UNII: 1K09F3G675)
  • ISODODECANE (UNII: A8289P68Y2)
  • ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)
  • WATER (UNII: 059QF0KO0R)
  • DIISOPROPYL SEBACATE (UNII: J8T3X564IH)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • LAURYL LACTATE (UNII: G5SU0BFK7O)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: System Beauty, Llc
Labeler Code: 82384
FDA Application Number: part352 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: OTC MONOGRAPH FINAL - A product marketed pursuant to a final Over-the-Counter (OTC) Drug Monograph. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-17-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Spf Bestsellers Starter Kit Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Unseen Sunscreen Active Ingredient

Active Ingredients PurposeAvobenzone 3% SunscreenHomosalate 8% SunscreenOctocrylene 4% SunscreenOctisalate 5% Sunscreen

Glowscreen Spf 40

Active Ingredients Purpose
Avobenzone 3% Sunscreen

Octisalate 5% Sunscreen

Octocylene 10% Sunscreen

Play Everyday Sunscreen Spf 50 With Sunflower Extract Active Ingredients

Active Ingredients PurposeAvobenzone 3% SunscreenHomosalate 10% SunscreenOctisalate 5% SunscreenOctocrylene 7.5% Sunscreen

Otc - Purpose

UsesHelps Prevent SunburnIf used as directed with other sun protection measures (see Directions), decreases the risk of Skin cancer and early skin aging caused by the sun

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Indications & Usage

Stop use and ask a doctor if rash occurs.

Warnings

For External use onlyDo not use on damaged or broken skin
When using this product, Keep out of eyes. Rinse with water to remove

Unseen Sunscreen Spf 40 Directions

  • Directionsapply generously and evenly 15 minutes before sun exposurereapply:after 40 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun 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 sunglassesChildren under 6 months: ask a doctor

Glowscreen Spf 40 Directions

  • Directions Apply generously and evenly 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 10a.m. – 2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor

Play Everyday Sunscreen Spf 50 With Sunflower Extract Directions

  • DirectionsApply liberally 15 minutes before sun exposureReapply:after 80 minutes of swimming or sweatingimmediately after towel dryingat least every 2 hoursSun 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 broad spectrum SPF 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 sunglassesChildren under 6 months: Ask a doctor

Unseen Sunscreen Inactive Ingredients

Inactive IngredientsIsododecane, Dimethicone Crosspolymer, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Polymethylsilsesquioxane, Isohexadecane, Dicrapylyl Carbonate, Meadowfoam Estolide, Caprylic/Capric Triglyceride, Polyester-7, Neopentyl Glycol Diheptanoate, Lithothamnion Calcareum Extract,Butyrospermum Parkii (Shea) Butter, Jojoba Esters, Mannitol, Boswellia Serrata Resin Extract, Lecithin, Microcrystalline Cellulose, Diatomaceous Earth, Zinc Sulfate, Silica, Tocopherol

Glowscreen Spf 40 Inactive Ingredients

Inactive Ingredients
Water, Propanediol, Butyloctyl Salicylate, Glycerin, C12-15 Alkyl Benzoate, Polymethylsilsesquioxane, Niacinamide, Glyceryl Stearate Citrate, Bismuth Oxychloride, Mica, Titanium Dioxide, Lauryl Lactate, Isododecane, Isodecyl Neopentanoate, Glyceryl Stearate, Diisopropyl Sebacate, Cetyl Phosphate, Caprylic/Capric Triglyceride, Coco-Caprylate, Ethylhexyl Hydroxystearate, Butylene Glycol, Arginine, Hydroxyacetophenone, Caprylyl Glycol, 1,2-Hexanediol, Iron Oxides, Sodium Hyaluronate, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trisodium Ethylenediamine Disuccinate, Phospholipids, Limonium Gerberi Extract, Leuconostoc/Radish Root Ferment Filtrate, Theobroma Cacao (Cocoa) Seed Extract, Pantothenic Acid, Tocopherol, Helianthus Annuus (sunflower) Seed Oil, Ferulic Acid

Play Everyday Lotion Spf 50 With Sunflower Extract

Inactive IngredientsWater, Acrylates Copolymer, Diisopropyl Sebacate, Glycerin, Isodecyl Neopentanoate, Isododecane, Lauryl Lactate, Cetyl Alcohol, Potassium Cetyl Phosphate, Brassica Camprestris/Aleurites Fordi Copolymer, Oryza Sativa (Rice) Bran Extract, Cetearyl Olivate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Hydroxyacetophenone, Sorbitan Olivate, Diethylhexyl Syringylidenemalonate, Aniba Rosaeodora (Rosewood) Wood Oil, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Oil, ​ Citrus Limon (Lemon) Peel Oil, Ethylhexylglycerin, Eucalyptus Globulus Leaf Oil, Ocimum Bascilicum (Basil) Flower/Leaf Extract, Pelargonium Graveolens Flower Oil, Pogostemon Cablin Oil, Pentylene Glycol, 1,2-hexanediol, Caprylyl Glycol, Xanthan Gum, Helianthus Annuus (Sunflower) Extract, Behenic Acid, Cetyl Behenate, Isostearyl Isostearate, Trisodium Ethylenediamene Disuccinate, Tocopherol, Allantoin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Caprylic/Capric Triglyceride,Panthenol, Pentasodium Triphosphate, Citric Acid

Spf Bestsellers Starter Kit

SPF BESTSELLERS STARTER KITDiscover healthier, happier skin with bestselling SPF for face & body.Unseen Sunscreen SPF 400.5 fl. oz. / 15 mlGlowscreen SPF 400.5fl. oz. / 15 mlPlay Everyday Lotion SPF 50 with Sunflower Extract1 fl. oz. / 30 ml

* Please review the disclaimer below.