100 % Mineral SPF Mini Set

Manufacturer
System Beauty, LLC
Effective date
2021-12-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:45:36

Key Label Information#

Active Ingredients And Purpose

Zincscreen 100% Mineral Lotion SPF 40 Active

Active Ingredients Purpose Zinc Oxide 13% Sunscreen

Mineral Mattescreen SPF 40 active

Active Ingredients Purpose Titanium Dioxide 1.3% Sunscreen Zinc Oxide 17.4% Sunscreen

Bright-Eyed 100% Mineral Eye Cream active

Active Ingredients Purpose Zinc Oxide 14.4% Sunscreen

Mineral Sheerscreen SPF 30 active

Active Ingredients Purpose Zinc Oxide 17.5% Sunscreen

Uses

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

Warnings

WARNINGS SECTION

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes

Directions And Dosage

DOSAGE & ADMINISTRATION SECTION

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 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglassess Children under 6 months: Ask a doctor.

Other Label Information

Zincscreen 100% Mineral Lotion SPF 40 Inactive ingredients

Inactive Ingredients Water, Tetradecane, Cetearyl Nonanoate, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Isopropyl Myristate, Glycerin, Polyglyceryl-3 Diisostearate, Mica, Propanediol, Disteardimonium Hectorite, Gluconolactone, Polyglyceryl-6 Polyricinoleate, Brassica Campestris/Aleurites Fordi Oil Copolymer, Polyhydrostearic Acid, Sodium Chloride, Magnesium Sulfate, Fructose, Octyldodecyl Oleate, Tocopherol, Cocos Nucifera (Coconut) Fruit Extract, Sodium Benzoate, Iron oxides (CI 77492), Dodecane, Hexadecane, Titanium Dioxide (CI 77891), Withania Somnifera Flower Extract, Iron Oxides (CI 77491), Vaccinium Angustifolia (Blueberry) Fruit Extract, Silica, Calcium Gluconate

Mineral Mattescreen SPF 40 Inactive Ingredients

Inactive Ingredients Dimethicone, Dimethicone Copolymer, 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)

Bright-Eyed Mineral Eye Cream SPF 40 inactive ingredients

Inactive Ingredients Water, Caprylic/Capric Triglyceride, Glycerin, Propanediol, Butyloctyl Salicylate, Glyceryl Stearate Citrate, Lauroyl Lysine, Cetyl Esters, Inulin Lauryl CarbamatePolyhydroxystearic Acid, Cetearyl Alcohol, Potassium Cetyl phosophate, Griffonia Simplicifolia Seed Extract, Titanium Dioxide, Olive Oil Polyglyceryl-6 Esters, Mica, Triethoxycaprylylsilane, Microcrystalline cellulose, Glyceryl Glucoside, Hydroxyacetophenone, Polyurethane-79, Diethylhexyl Syringylidenemalonate, Sodium Stearoyl Lactylate, 1,2-Hexanediol, Caprylyl Glycol, Sodium Citrate, Trisodium Ethylenediamine Disuccinate, Camellia Sinensis Leaf Extract, Lactobacillus Ferment Lysate, Punica Granatum Extract, Sodium Citrate, Sodium Stearoyl Glutamate, Xanthan Gum, Cellulose Gum, Iron Oxides, Hedychium Coronarium Root Extract, Lactobacillus Ferment, Caffeine, Leuconostoc/Radish Root Ferment Filtrate, Tin Oxide.

Mineral Sheerscreen SPF 30 Inactive ingredients

Inactive ingredients Water, Isododecane, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Propanedlol, 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, lsostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylhydroxamic Acid, Citric Acid, Aloe Barbadensis Leaf Juice, Lespedeza Capitata Leaf/Stem Extract, Maltodextrin, Sodium Hyaluronate

Label Images#

100 Mineral SPF Mini Set_Card Insert_FRONT PANEL
100 Mineral SPF Mini Set_Card Insert_FRONT PANEL
100 Mineral SPF Mini Set_Card Insert_BACK PANELjpg
100 Mineral SPF Mini Set_Card Insert_BACK PANELjpg
Zincscreen SPF 40_10ml_TUBE
Zincscreen SPF 40_10ml_TUBE
Mineral Mattescreen SPF 40_10ml_TUBE
Mineral Mattescreen SPF 40_10ml_TUBE
Bright-Eyed SPF 40_5ml_TUBE
Bright-Eyed SPF 40_5ml_TUBE
Mineral Sheerscreen SPF 30_ 10ml_TUBE.
Mineral Sheerscreen SPF 30_ 10ml_TUBE.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82384-0020-12023-01-30C16284748780-1f386c64a-18ed-0266-e053-dadaa90a7c1a100% Mineral SPF Mini Set

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82384-0020-1100 % Mineral SPF Mini Set1 in 1 KITKIT11
82384-0021-1100 % Mineral SPF Mini Set10 mL in 1 TUBECREAM10 mL in 3517.5 g in 100mL1
82384-0022-1100 % Mineral SPF Mini Set10 mL in 1 TUBECREAM10 mL in 3517.4 g in 100mL1
82384-0023-1100 % Mineral SPF Mini Set10 mL in 1 TUBELOTION10 mL in 3513 g in 100mL1
82384-0024-1100 % Mineral SPF Mini Set5 mL in 1 TUBECREAM5 mL in 3514.4 g in 100mL1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82384-0020100 % MINERAL SPF MINI SET (ZINC OXIDE, TITANIUM DIOXIDE) KIT [SYSTEM BEAUTY, LLC]1Legacy NDC, 5 package rows20211212_d2bf436c-eaf1-0fa8-e053-2995a90ab59a.zip
82384-0021100 % MINERAL SPF MINI SET (ZINC OXIDE, TITANIUM DIOXIDE) KIT [SYSTEM BEAUTY, LLC]1Unmatched20211212_d2bf436c-eaf1-0fa8-e053-2995a90ab59a.zip
82384-0022100 % MINERAL SPF MINI SET (ZINC OXIDE, TITANIUM DIOXIDE) KIT [SYSTEM BEAUTY, LLC]1Unmatched20211212_d2bf436c-eaf1-0fa8-e053-2995a90ab59a.zip
82384-0023100 % MINERAL SPF MINI SET (ZINC OXIDE, TITANIUM DIOXIDE) KIT [SYSTEM BEAUTY, LLC]1Unmatched20211212_d2bf436c-eaf1-0fa8-e053-2995a90ab59a.zip
82384-0024100 % MINERAL SPF MINI SET (ZINC OXIDE, TITANIUM DIOXIDE) KIT [SYSTEM BEAUTY, LLC]1Unmatched20211212_d2bf436c-eaf1-0fa8-e053-2995a90ab59a.zip

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82384-002082384-0020-1
82384-002182384-0021-1
82384-002282384-0022-1
82384-002382384-0023-1
82384-002482384-0024-1

Ingredients#

Name, UNII, Kind table
NameUNIIKind
MALTODEXTRIN7CVR7L4A2DIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S)Q7UI015FF9IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ISODODECANEA8289P68Y2IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ZINC OXIDESOI2LOH54ZACTIB
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PROPANEDIOL5965N8W85TIACT
GLYCERINPDC6A3C0OXIACT
SQUALANEGW89575KF9IACT
POLYGLYCERIN-34A0NCJ6RD6IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
XANTHAN GUMTTV12P4NEEIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
HYALURONATE SODIUMYSE9PPT4THIACT
WATER059QF0KO0RIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
TRIOCTYLDODECYL CITRATE35X8CT063RIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
ZINC OXIDESOI2LOH54ZACTIB
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
TITANIUM DIOXIDE15FIX9V2JPACTIB
HEDYCHIUM CORONARIUM ROOT92A6N0IQN9IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
DIMETHICONE92RU3N3Y1OIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
METHYL DIHYDROABIETATE7666FJ0J9FIACT
WATER059QF0KO0RIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
STEARIC ACID4ELV7Z65APIACT
FERRIC OXIDE RED1K09F3G675IACT
ETHYLHEXYL PALMITATE2865993309IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
CETEARYL NONANOATEF6ZWV2F361IACT
SODIUM CHLORIDE451W47IQ8XIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
FRUCTOSE6YSS42VSEVIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HEXADECANEF8Z00SHP6QIACT
ISOPROPYL PALMITATE8CRQ2TH63MIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
CALCIUM GLUCONATESQE6VB453KIACT
SODIUM BENZOATEOJ245FE5EUIACT
ZINC OXIDESOI2LOH54ZACTIB
TETRADECANE03LY784Y58IACT
GLUCONOLACTONEWQ29KQ9POTIACT
LOWBUSH BLUEBERRYG90PX41VP0IACT
POLYGLYCERYL-6 POLYRICINOLEATEYPM0ZOC2HRIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TOCOPHEROLR0ZB2556P8IACT
COCONUT3RT3536DHYIACT
POLYGLYCERYL-3 DIISOSTEARATE46P231IQV8IACT
GLYCERINPDC6A3C0OXIACT
WITHANIA SOMNIFERA FLOWER2HZ95R7082IACT
FERRIC OXIDE RED1K09F3G675IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
DODECANE11A386X1QHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MICAV8A1AW0880IACT
PROPANEDIOL5965N8W85TIACT
DISTEARDIMONIUM HECTORITEX687XDK09LIACT
GRIFFONIA SIMPLICIFOLIA SEEDLUS5142TMYIACT
MICAV8A1AW0880IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMK679OBS311IACT

Complete SPL Sections#

Zincscreen 100% Mineral Lotion SPF 40 Active

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose Zinc Oxide 13% Sunscreen

Mineral Mattescreen SPF 40 active

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose Titanium Dioxide 1.3% Sunscreen Zinc Oxide 17.4% Sunscreen

Bright-Eyed 100% Mineral Eye Cream active

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose Zinc Oxide 14.4% Sunscreen

Mineral Sheerscreen SPF 30 active

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose Zinc Oxide 17.5% Sunscreen

OTC - PURPOSE SECTION

OTC - PURPOSE SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

WARNINGS SECTION

Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

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 10 a.m. - 2 p.m. Wear long-sleeved shirts, pants, hats, and sunglassess Children under 6 months: Ask a doctor.

Zincscreen 100% Mineral Lotion SPF 40 Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Tetradecane, Cetearyl Nonanoate, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Isopropyl Myristate, Glycerin, Polyglyceryl-3 Diisostearate, Mica, Propanediol, Disteardimonium Hectorite, Gluconolactone, Polyglyceryl-6 Polyricinoleate, Brassica Campestris/Aleurites Fordi Oil Copolymer, Polyhydrostearic Acid, Sodium Chloride, Magnesium Sulfate, Fructose, Octyldodecyl Oleate, Tocopherol, Cocos Nucifera (Coconut) Fruit Extract, Sodium Benzoate, Iron oxides (CI 77492), Dodecane, Hexadecane, Titanium Dioxide (CI 77891), Withania Somnifera Flower Extract, Iron Oxides (CI 77491), Vaccinium Angustifolia (Blueberry) Fruit Extract, Silica, Calcium Gluconate

Mineral Mattescreen SPF 40 Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients Dimethicone, Dimethicone Copolymer, 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)

Bright-Eyed Mineral Eye Cream SPF 40 inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients Water, Caprylic/Capric Triglyceride, Glycerin, Propanediol, Butyloctyl Salicylate, Glyceryl Stearate Citrate, Lauroyl Lysine, Cetyl Esters, Inulin Lauryl CarbamatePolyhydroxystearic Acid, Cetearyl Alcohol, Potassium Cetyl phosophate, Griffonia Simplicifolia Seed Extract, Titanium Dioxide, Olive Oil Polyglyceryl-6 Esters, Mica, Triethoxycaprylylsilane, Microcrystalline cellulose, Glyceryl Glucoside, Hydroxyacetophenone, Polyurethane-79, Diethylhexyl Syringylidenemalonate, Sodium Stearoyl Lactylate, 1,2-Hexanediol, Caprylyl Glycol, Sodium Citrate, Trisodium Ethylenediamine Disuccinate, Camellia Sinensis Leaf Extract, Lactobacillus Ferment Lysate, Punica Granatum Extract, Sodium Citrate, Sodium Stearoyl Glutamate, Xanthan Gum, Cellulose Gum, Iron Oxides, Hedychium Coronarium Root Extract, Lactobacillus Ferment, Caffeine, Leuconostoc/Radish Root Ferment Filtrate, Tin Oxide.

Mineral Sheerscreen SPF 30 Inactive ingredients

INACTIVE INGREDIENT SECTION

Inactive ingredients Water, Isododecane, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, Propanedlol, 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, lsostearic Acid, Lecithin, Polyglyceryl-3 Polyricinoleate, Polyhydroxystearic Acid, Caprylhydroxamic Acid, Citric Acid, Aloe Barbadensis Leaf Juice, Lespedeza Capitata Leaf/Stem Extract, Maltodextrin, Sodium Hyaluronate

100% Mineral SPF Mini Set

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

100% Mineral SPF Mini Set Nourish, prep and protect your skin with this sample set, featuring our 100% mineral lineup Mineral Sheerscreen SPF 30 (10 ml) Mineral Mattescreen SPF 40 (10 ml) Zincscreen 100% Mineral Lotion SPF 40 (10 ml) Bright-eyed 100% Mineral Eye Cream (5 ml)

Zincscreen 100% Mineral SPF 40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Zincscreen 100% Mineral Lotion SPF 40 Broad Spectrum SunscreenSPF 40 PA+++ 0.34 fl oz./ 10ml

Mineral Mattescreen SPF 40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral Mattescreen SPF 40 100% Mineral Broad Spectrum Sunscreen SPF 40 PA+++ 0.34 fl. oz. /10 ml

Bright-eyed Mineral Eye Cream SPF 40

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bright-eyed 100% Mineral Eye Cream SPF 40 Broad Spectrum Sunscreen SPF 40 PA +++ 0.17 fl.oz. / 5 ml

Mineral Sheerscreen SPF 30

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mineral Sheerscreen SPF 30 100% Mineral Broad Spectrum Sunscreen SPF 30 PA+++ 0.34 fl. oz.

Source Document#

Source XML