| NDC | 67345-0001-0, 67345-0002-0, 67345-0003-0, 67345-0004-0 |
| Set ID | b9d80f01-620a-4b00-8b00-746f2f7c467b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Purminerals |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Medicinal Ingredient/Active Ingredient
- Purpose
- Uses
- Warnings
-
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
-
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
- PRINCIPAL DISPLAY PANEL - 50 g Tube Carton - Light
- PRINCIPAL DISPLAY PANEL - 50 g Tube Carton - Medium
- PRINCIPAL DISPLAY PANEL - 50 g Tube Carton - Tan
- 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 creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67345-0001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 5 g in 100 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 5 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:67345-0001-0 1 in 1 CARTON 03/01/2012 1 50 g 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 NOT FINAL part352 03/01/2012 PURMINERALS 4-IN-1 MINERAL TINTED MOISTURIZER BROAD SPECTRUM SPF 20 (MEDIUM)
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67345-0002 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 5 g in 100 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 5 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:67345-0002-0 1 in 1 CARTON 03/01/2012 1 50 g 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 NOT FINAL part352 03/01/2012 PURMINERALS 4-IN-1 MINERAL TINTED MOISTURIZER BROAD SPECTRUM SPF 20 (TAN)
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67345-0003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 5 g in 100 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 5 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:67345-0003-0 1 in 1 CARTON 03/01/2012 1 50 g 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 NOT FINAL part352 03/01/2012 PURMINERALS 4-IN-1 MINERAL TINTED MOISTURIZER BROAD SPECTRUM SPF 20 (DARK)
titanium dioxide and zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67345-0004 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 5 g in 100 g Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 5 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:67345-0004-0 1 in 1 CARTON 03/01/2012 1 50 g 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 NOT FINAL part352 03/01/2012 Labeler - Purminerals (114450443)
