| NDC | 51060-114-01, 51060-115-01, 51060-116-01 |
| Set ID | 1cbc82c7-59c2-418e-b187-238ca7c154b8 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Tarte, Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
-
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.
- Warnings
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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.
- Optional: apply to all skin exposed to the sun.
-
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 information
-
Inactive ingredients
Water, cyclopentasiloxane, PEG/PPG-18/18 dimethicone, octyldodecyl neopentanoate, glycerin, dimethicone, aluminum hydroxide, stearic acid, phenoxyethanol, mica, boron nitride, sodium dehydroacetate, caprylyl glycol, sodium chloride, phytantriol, kaolin, magnesium ascorbyl phosphate, palmitic acid, dextrin palmitate, sodium hyaluronate, hexylene glycol, retinyl palmitate, tocopheryl acetate, tocopherol, tetrahexyldecyl ascorbate, methicone, butylene glycol, triethoxycaprylylsilane, calcium sodium phosphosilicate, saccharum officinarum (sugar cane) extract, pyrus malus (apple) fruit extract, citrus limon (lemon) fruit extract, citrus aurantium dulcis (orange) fruit extract, camellia oleifera leaf extract, panax ginseng root extract, ginkgo biloba leaf extract, anthemis nobilis flower extract, iron oxides.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - light
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - light-medium
- PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton - medium
-
INGREDIENTS AND APPEARANCE
TARTEGUARD 20 TINTED MOISTURIZER LIGHT
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-114 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 50 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794) octyldodecyl neopentanoate (UNII: X8725R883T) glycerin (UNII: PDC6A3C0OX) dimethicone (UNII: 92RU3N3Y1O) aluminum hydroxide (UNII: 5QB0T2IUN0) stearic acid (UNII: 4ELV7Z65AP) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) boron nitride (UNII: 2U4T60A6YD) sodium dehydroacetate (UNII: 8W46YN971G) caprylyl glycol (UNII: 00YIU5438U) sodium chloride (UNII: 451W47IQ8X) phytantriol (UNII: 8LVI07A72W) kaolin (UNII: 24H4NWX5CO) magnesium ascorbyl phosphate (UNII: 0R822556M5) palmitic acid (UNII: 2V16EO95H1) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) vitamin A palmitate (UNII: 1D1K0N0VVC) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) methicone (20 cst) (UNII: 6777U11MKT) butylene glycol (UNII: 3XUS85K0RA) triethoxycaprylylsilane (UNII: LDC331P08E) sugarcane (UNII: 81H2R5AOH3) apple (UNII: B423VGH5S9) lemon (UNII: 24RS0A988O) orange (UNII: 5EVU04N5QU) camellia oleifera leaf (UNII: 5077EL0C60) asian ginseng (UNII: CUQ3A77YXI) ginkgo (UNII: 19FUJ2C58T) chamaemelum nobile flower (UNII: O2T154T6OG) ferric oxide red (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51060-114-01 1 in 1 CARTON 04/01/2017 1 50 mL in 1 BOTTLE; 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 04/01/2017 TARTEGUARD 20 TINTED MOISTURIZER LIGHT-MEDIUM
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-115 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 50 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794) octyldodecyl neopentanoate (UNII: X8725R883T) glycerin (UNII: PDC6A3C0OX) dimethicone (UNII: 92RU3N3Y1O) aluminum hydroxide (UNII: 5QB0T2IUN0) stearic acid (UNII: 4ELV7Z65AP) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) boron nitride (UNII: 2U4T60A6YD) sodium dehydroacetate (UNII: 8W46YN971G) caprylyl glycol (UNII: 00YIU5438U) sodium chloride (UNII: 451W47IQ8X) phytantriol (UNII: 8LVI07A72W) kaolin (UNII: 24H4NWX5CO) magnesium ascorbyl phosphate (UNII: 0R822556M5) palmitic acid (UNII: 2V16EO95H1) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) vitamin A palmitate (UNII: 1D1K0N0VVC) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) methicone (20 cst) (UNII: 6777U11MKT) butylene glycol (UNII: 3XUS85K0RA) triethoxycaprylylsilane (UNII: LDC331P08E) sugarcane (UNII: 81H2R5AOH3) apple (UNII: B423VGH5S9) lemon (UNII: 24RS0A988O) orange (UNII: 5EVU04N5QU) camellia oleifera leaf (UNII: 5077EL0C60) asian ginseng (UNII: CUQ3A77YXI) ginkgo (UNII: 19FUJ2C58T) chamaemelum nobile flower (UNII: O2T154T6OG) ferric oxide red (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51060-115-01 1 in 1 CARTON 04/01/2017 1 50 mL in 1 BOTTLE; 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 04/01/2017 TARTEGUARD 20 TINTED MOISTURIZER MEDIUM
titanium dioxide and zinc oxide liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51060-116 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP) Titanium Dioxide 50 mg in 1 mL Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength water (UNII: 059QF0KO0R) cyclomethicone 5 (UNII: 0THT5PCI0R) peg/ppg-18/18 dimethicone (UNII: 9H0AO7T794) octyldodecyl neopentanoate (UNII: X8725R883T) glycerin (UNII: PDC6A3C0OX) dimethicone (UNII: 92RU3N3Y1O) aluminum hydroxide (UNII: 5QB0T2IUN0) stearic acid (UNII: 4ELV7Z65AP) phenoxyethanol (UNII: HIE492ZZ3T) mica (UNII: V8A1AW0880) boron nitride (UNII: 2U4T60A6YD) sodium dehydroacetate (UNII: 8W46YN971G) caprylyl glycol (UNII: 00YIU5438U) sodium chloride (UNII: 451W47IQ8X) phytantriol (UNII: 8LVI07A72W) kaolin (UNII: 24H4NWX5CO) magnesium ascorbyl phosphate (UNII: 0R822556M5) palmitic acid (UNII: 2V16EO95H1) hyaluronate sodium (UNII: YSE9PPT4TH) hexylene glycol (UNII: KEH0A3F75J) vitamin A palmitate (UNII: 1D1K0N0VVC) .alpha.-tocopherol acetate (UNII: 9E8X80D2L0) tocopherol (UNII: R0ZB2556P8) tetrahexyldecyl ascorbate (UNII: 9LBV3F07AZ) methicone (20 cst) (UNII: 6777U11MKT) butylene glycol (UNII: 3XUS85K0RA) triethoxycaprylylsilane (UNII: LDC331P08E) sugarcane (UNII: 81H2R5AOH3) apple (UNII: B423VGH5S9) lemon (UNII: 24RS0A988O) orange (UNII: 5EVU04N5QU) camellia oleifera leaf (UNII: 5077EL0C60) asian ginseng (UNII: CUQ3A77YXI) ginkgo (UNII: 19FUJ2C58T) chamaemelum nobile flower (UNII: O2T154T6OG) ferric oxide red (UNII: 1K09F3G675) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51060-116-01 1 in 1 CARTON 04/01/2017 1 50 mL in 1 BOTTLE; 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 04/01/2017 Labeler - Tarte, Inc (027905186)
