100 % MINERAL SPF MINI SET- zinc oxide, titanium dioxide 
System Beauty, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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100% Mineral SPF Mini Set

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

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

Stop use and ask a doctor if rash occurs

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes

Directions

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

100% Mineral SPF Mini Set

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)

front card insert

card insert back

Zincscreen 100% Mineral SPF 40

Zincscreen 100% Mineral Lotion

SPF 40

Broad Spectrum SunscreenSPF 40 PA+++

0.34 fl oz./ 10ml

zincscreen tube

Mineral Mattescreen SPF 40

Mineral Mattescreen

SPF 40

100% Mineral

Broad Spectrum Sunscreen

SPF 40 PA+++

0.34 fl. oz. /10 ml

mineral mattescreen tube

Bright-eyed Mineral Eye Cream SPF 40

Bright-eyed

100% Mineral Eye Cream

SPF 40

Broad Spectrum Sunscreen SPF 40 PA +++

0.17 fl.oz. / 5 ml

Bright eyed SPF 40

Mineral Sheerscreen SPF 30

Mineral Sheerscreen

SPF 30

100% Mineral Broad Spectrum Sunscreen SPF 30 PA+++

0.34 fl. oz.

mineral Sheerscreen tube

100 % MINERAL SPF MINI SET 
zinc oxide, titanium dioxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82384-0020
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82384-0020-11 in 1 KIT; Type 0: Not a Combination Product07/30/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 10 mL  in 35 
Part 21 TUBE 10 mL  in 35 
Part 31 TUBE 10 mL  in 35 
Part 41 TUBE 5 mL  in 35 
Part 1 of 4
MINERAL SHEERSCREEN SPF 30 
zinc oxide cream
Product Information
Item Code (Source)NDC:82384-0021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN (UNII: 7CVR7L4A2D)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ISODODECANE (UNII: A8289P68Y2)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ISOSTEARIC ACID (UNII: X33R8U0062)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
PROPANEDIOL (UNII: 5965N8W85T)  
GLYCERIN (UNII: PDC6A3C0OX)  
SQUALANE (UNII: GW89575KF9)  
POLYGLYCERIN-3 (UNII: 4A0NCJ6RD6)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
XANTHAN GUM (UNII: TTV12P4NEE)  
POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
WATER (UNII: 059QF0KO0R)  
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
TRIOCTYLDODECYL CITRATE (UNII: 35X8CT063R)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82384-0021-110 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/30/2021
Part 2 of 4
MINERAL MATTESCREEN SPF 40 
titanium dioxide, zinc oxide cream
Product Information
Item Code (Source)NDC:82384-0022
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE17.4 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE1.3 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F)  
WATER (UNII: 059QF0KO0R)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82384-0022-110 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/30/2021
Part 3 of 4
ZINCSCREEN 100% MINERAL SPF 40 
zinc oxide lotion
Product Information
Item Code (Source)NDC:82384-0023
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE13 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
WATER (UNII: 059QF0KO0R)  
CETEARYL NONANOATE (UNII: F6ZWV2F361)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
MAGNESIUM SULFATE ANHYDROUS (UNII: ML30MJ2U7I)  
FRUCTOSE (UNII: 6YSS42VSEV)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
HEXADECANE (UNII: F8Z00SHP6Q)  
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
CALCIUM GLUCONATE (UNII: SQE6VB453K)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
TETRADECANE (UNII: 03LY784Y58)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
LOWBUSH BLUEBERRY (UNII: G90PX41VP0)  
POLYGLYCERYL-6 POLYRICINOLEATE (UNII: YPM0ZOC2HR)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
TOCOPHEROL (UNII: R0ZB2556P8)  
COCONUT (UNII: 3RT3536DHY)  
POLYGLYCERYL-3 DIISOSTEARATE (UNII: 46P231IQV8)  
GLYCERIN (UNII: PDC6A3C0OX)  
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
DODECANE (UNII: 11A386X1QH)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MICA (UNII: V8A1AW0880)  
PROPANEDIOL (UNII: 5965N8W85T)  
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82384-0023-110 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/30/2021
Part 4 of 4
BRIGHT- EYED 100% MINERAL EYE CREAM 
zinc oxide cream
Product Information
Item Code (Source)NDC:82384-0024
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14.4 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GRIFFONIA SIMPLICIFOLIA SEED (UNII: LUS5142TMY)  
MICA (UNII: V8A1AW0880)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
PROPANEDIOL (UNII: 5965N8W85T)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM STEAROYL LACTYLATE (UNII: IN99IT31LN)  
CAFFEINE (UNII: 3G6A5W338E)  
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)  
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
STANNIC OXIDE (UNII: KM7N50LOS6)  
GLYCERYL STEARATE CITRATE (UNII: WH8T92A065)  
LAUROYL LYSINE (UNII: 113171Q70B)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
OLIVE OIL POLYGLYCERYL-6 ESTERS (UNII: 4KDO9AFM9I)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82384-0024-15 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/30/2021
Labeler - System Beauty, LLC (809198398)

Revised: 12/2021
Document Id: d2bf43bc-9742-0fb0-e053-2995a90a556e
Set id: d2bf436c-eaf1-0fa8-e053-2995a90ab59a
Version: 1
Effective Time: 20211209
 
System Beauty, LLC