100 % MINERAL SPF MINI SET- zinc oxide, titanium dioxide kit

100 % Mineral SPF Mini Set by

Drug Labeling and Warnings

100 % Mineral SPF Mini Set by is a Otc medication manufactured, distributed, or labeled by System Beauty, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

PURPOSE

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

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

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes

DOSAGE & ADMINISTRATION

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 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)

Zincscreen 100% Mineral SPF 40

Zincscreen 100% Mineral Lotion

SPF 40

Broad Spectrum SunscreenSPF 40 PA+++

0.34 fl oz./ 10ml

Mineral Mattescreen SPF 40

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

Bright-eyed

100% Mineral Eye Cream

SPF 40

Broad Spectrum Sunscreen SPF 40 PA +++

0.17 fl.oz. / 5 ml

Mineral Sheerscreen SPF 30

Mineral Sheerscreen

SPF 30

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

0.34 fl. oz.

INGREDIENTS AND APPEARANCE

100 % MINERAL SPF MINI SET 
zinc oxide, titanium dioxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82384-0020

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82384-0020-1	1 in 1 KIT; Type 0: Not a Combination Product	07/30/2021

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	10 mL  in 35
Part 2	1 TUBE	10 mL  in 35
Part 3	1 TUBE	10 mL  in 35
Part 4	1 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 Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82384-0021-1	10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/30/2021

Part 2 of 4

MINERAL MATTESCREEN SPF 40 
titanium dioxide, zinc oxide cream

Product Information
Item Code (Source)	NDC: 82384-0022
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	17.4 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82384-0022-1	10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/30/2021

Part 3 of 4

ZINCSCREEN 100% MINERAL SPF 40 
zinc oxide lotion

Product Information
Item Code (Source)	NDC: 82384-0023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	13 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82384-0023-1	10 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/30/2021

Part 4 of 4

BRIGHT- EYED 100% MINERAL EYE CREAM 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 82384-0024
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82384-0024-1	5 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/30/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/30/2021

Labeler - System Beauty, LLC (809198398)