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

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 9, 2021

If you are a consumer or patient please visit this version.

  • 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)

    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

  • INGREDIENTS AND APPEARANCE
    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)