Label: PURMINERALS 4-IN-1 MINERAL TINTED MOISTURIZER BROAD SPECTRUM SPF 20 (LIGHT)- titanium dioxide and zinc oxide cream
PURMINERALS 4-IN-1 MINERAL TINTED MOISTURIZER BROAD SPECTRUM SPF 20 (MEDIUM)- titanium dioxide and zinc oxide cream
PURMINERALS 4-IN-1 MINERAL TINTED MOISTURIZER BROAD SPECTRUM SPF 20 (TAN)- titanium dioxide and zinc oxide cream
PURMINERALS 4-IN-1 MINERAL TINTED MOISTURIZER BROAD SPECTRUM SPF 20 (DARK)- titanium dioxide and zinc oxide cream

  • NDC Code(s): 67345-0001-1, 67345-0002-1, 67345-0003-1, 67345-0004-1
  • Packager: Purminerals
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 January 24, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Medicinal Ingredient/Active Ingredient

    Titanium Dioxide 5.0% w/w, Zinc Oxide 5.0% w/w

  • Purpose

    Sunscreen

  • Uses

    Helps prevent sunburn.

  • Warnings

    For external use only

    • Do not use on damaged or broken skin

    • Stop use and ask a doctor if rash occurs

    • When using this product, keep out of eyes. Rinse with water to remove

    • Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.
  • Directions

    Apply liberally 15 minutes before sun exposure

    • Use a water resistant sunscreen if swimming or sweating
    • Reapply at least every 2 hours
    • Children under 6 months: ask a doctor

    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 sunglasses.
  • Other

    Protect this product from excessive heat and direct sun

    • In the unlikely event of an adverse reaction, please contact 1.866.PUR.0022.
  • Non-Medicinal Ingredients/ Inactive Ingredients

    Aqua, Cyclopentasiloxane, Butylene Glycol, Octyldodecyl Neopentanoate, PEG/PPG-18/18 Dimethicone, Dimethicone, Magnesium Chloride, Potassium Chloride, Sodium Chloride, Zinc Chloride, Lysine, Butyrospermum Parkii (Shea) Butter, Panax Ginseng Root Extract, Ginkgo Biloba Leaf Extract, Anthemis Nobilis Flower Extract, Camellia Oleifera Leaf Extract, Aloe Barbadensis Leaf Extract, Phytantriol, Magnesium Ascorbyl Phosphate, Retinyl Palmitate, Tocopheryl Acetate, Tocopherol, Tetrahexyldecyl Ascorbate, Aluminum Hydroxide, Stearic Acid, Lactic Acid, Triethoxycaprylylsilane, Boron Nitride, Glycerin, Palmitic Acid, Dextrin Palmitate, Sodium Starch Octenylsuccinate, Retinol, Ceramide AP, Sodium Hyaluronate, Sodium Dehydroacetate, Disodium EDTA, Phenoxyethanol, Caprylyl Glycol, Hexylene Glycol, May Contain: Mica, Iron Oxides (CI 77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891)

  • SPL UNCLASSIFIED SECTION

    Distributed by pürminerals® Atlanta, GA 30327

  • PRINCIPAL DISPLAY PANEL - 50 g Tube Carton - Light

    PÜR™

    4-in-1
    Tinted Moisturizer

    Broad Spectrum SPF 20

    Titanium Dioxide 5.0% w/w | Zinc Oxide 5.0% w/w
    NPN 80028981
    NET WT. 1 .7 OZ / 50 g

    Principal Display Panel - 50 g Tube Carton - Light
  • PRINCIPAL DISPLAY PANEL - 50 g Tube Carton - Medium

    PÜR™

    4-in-1
    Tinted Moisturizer

    Broad Spectrum SPF 20

    Titanium Dioxide 5.0% w/w | Zinc Oxide 5.0% w/w
    NPN 80028981
    NET WT. 1 .7 OZ / 50 g

    Principal Display Panel - 50 g Tube Carton - Medium
  • PRINCIPAL DISPLAY PANEL - 50 g Tube Carton - Tan

    PÜR™

    4-in-1
    Tinted Moisturizer

    Broad Spectrum SPF 20

    Titanium Dioxide 5.0% w/w | Zinc Oxide 5.0% w/w
    NPN 80028981
    NET WT. 1 .7 OZ / 50 g

    Principal Display Panel - 50 g Tube Carton - Tan
  • PRINCIPAL DISPLAY PANEL - 50 g Tube Carton - Dark

    PÜR™

    4-in-1
    Tinted Moisturizer

    Broad Spectrum SPF 20

    Titanium Dioxide 5.0% w/w | Zinc Oxide 5.0% w/w
    NPN 80028981
    NET WT. 1 .7 OZ / 50 g

    Principal Display Panel - 50 g Tube Carton - Dark
  • INGREDIENTS AND APPEARANCE
    PURMINERALS 4-IN-1 MINERAL TINTED MOISTURIZER BROAD SPECTRUM SPF 20 (LIGHT) 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67345-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide5 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    WATER (UNII: 059QF0KO0R)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GINKGO (UNII: 19FUJ2C58T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    LYSINE (UNII: K3Z4F929H6)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    RETINOL (UNII: G2SH0XKK91)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67345-0001-11 in 1 CARTON03/01/2012
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35203/01/2012
    PURMINERALS 4-IN-1 MINERAL TINTED MOISTURIZER BROAD SPECTRUM SPF 20 (MEDIUM) 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67345-0002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide5 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    WATER (UNII: 059QF0KO0R)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GINKGO (UNII: 19FUJ2C58T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    LYSINE (UNII: K3Z4F929H6)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    RETINOL (UNII: G2SH0XKK91)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67345-0002-11 in 1 CARTON03/01/2012
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35203/01/2012
    PURMINERALS 4-IN-1 MINERAL TINTED MOISTURIZER BROAD SPECTRUM SPF 20 (TAN) 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67345-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide5 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    WATER (UNII: 059QF0KO0R)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GINKGO (UNII: 19FUJ2C58T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    LYSINE (UNII: K3Z4F929H6)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    RETINOL (UNII: G2SH0XKK91)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67345-0003-11 in 1 CARTON03/01/2012
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35203/01/2012
    PURMINERALS 4-IN-1 MINERAL TINTED MOISTURIZER BROAD SPECTRUM SPF 20 (DARK) 
    titanium dioxide and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67345-0004
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide5 g  in 100 g
    Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    WATER (UNII: 059QF0KO0R)  
    BORON NITRIDE (UNII: 2U4T60A6YD)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GINKGO (UNII: 19FUJ2C58T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT)  
    LYSINE (UNII: K3Z4F929H6)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    ASIAN GINSENG (UNII: CUQ3A77YXI)  
    PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PHYTANTRIOL (UNII: 8LVI07A72W)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    RETINOL (UNII: G2SH0XKK91)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM DEHYDROACETATE (UNII: 8W46YN971G)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ZINC CHLORIDE (UNII: 86Q357L16B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MICA (UNII: V8A1AW0880)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67345-0004-11 in 1 CARTON03/01/2012
    150 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart35203/01/2012
    Labeler - Purminerals (114450443)
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