foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 13N fair neutral, foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 22N light neutral, foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 27N light-m
Generic: TITANIUM DIOXIDE AND ZINC OXIDE
Basic Information
Manufacturer
Tarte, Inc.
Product Type
HUMAN OTC DRUG
Route of Administration
TOPICAL
FDA Set ID
f5d54e9d-4963-419a-a091-bdbd1decd2b8
Purpose
Active Ingredients Purpose Titanium Dioxide 7.47% Sunscreen Zinc Oxide 4.75% Sunscreen
Indications & Usage
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.
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
Warnings For external use only.
Stop use and ask doctor if rash occurs.
Do not use on damaged or broken skin.
When using this product keep out of eyes.
Rinse with water to remove.
Keep out of the reach of children .
If swallowed, get medical help or contact a Poison Control Center right away.
Stop use and ask doctor if rash occurs.
Do not use on damaged or broken skin.
When using this product keep out of eyes.
Rinse with water to remove.
Keep out of the reach of children .
If swallowed, get medical help or contact a Poison Control Center right away.
Technical Data
{
"spl_product_data_elements": [
"foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 13N fair neutral TITANIUM DIOXIDE AND ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER PHENYL TRIMETHICONE BUTYLENE GLYCOL DIMETHICONE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE BUTYLOCTYL SALICYLATE CYCLOMETHICONE 6 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) BIS-DIGLYCERYL POLYACYLADIPATE-2 ALUMINUM HYDROXIDE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER BABASSU OIL SODIUM CHLORIDE STEARIC ACID POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CALCIUM STEARATE DISTEARDIMONIUM HECTORITE TRIETHOXYCAPRYLYLSILANE SODIUM BENZOATE POTASSIUM SORBATE TOCOPHEROL POLYHYDROXYSTEARIC ACID (2300 MW) SUNFLOWER OIL ETHYLHEXYL PALMITATE ISOPROPYL MYRISTATE ISOSTEARIC ACID LECITHIN, SOYBEAN EDETATE DISODIUM ANHYDROUS CYCLOMETHICONE 5 POLYGLYCERYL-3 PENTARICINOLEATE KAOLIN CYCLOMETHICONE 4 PHENOXYETHANOL HYALURONATE SODIUM ETHYLHEXYLGLYCERIN HYALURONIC ACID FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 22N light neutral TITANIUM DIOXIDE AND ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER PHENYL TRIMETHICONE BUTYLENE GLYCOL DIMETHICONE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE BUTYLOCTYL SALICYLATE CYCLOMETHICONE 6 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) BIS-DIGLYCERYL POLYACYLADIPATE-2 ALUMINUM HYDROXIDE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER BABASSU OIL SODIUM CHLORIDE STEARIC ACID POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CALCIUM STEARATE DISTEARDIMONIUM HECTORITE TRIETHOXYCAPRYLYLSILANE SODIUM BENZOATE POTASSIUM SORBATE TOCOPHEROL POLYHYDROXYSTEARIC ACID (2300 MW) SUNFLOWER OIL ETHYLHEXYL PALMITATE ISOPROPYL MYRISTATE ISOSTEARIC ACID LECITHIN, SOYBEAN EDETATE DISODIUM ANHYDROUS CYCLOMETHICONE 5 POLYGLYCERYL-3 PENTARICINOLEATE KAOLIN CYCLOMETHICONE 4 PHENOXYETHANOL HYALURONATE SODIUM ETHYLHEXYLGLYCERIN HYALURONIC ACID FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 27N light-medium neutral TITANIUM DIOXIDE AND ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER PHENYL TRIMETHICONE BUTYLENE GLYCOL DIMETHICONE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE BUTYLOCTYL SALICYLATE CYCLOMETHICONE 6 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) BIS-DIGLYCERYL POLYACYLADIPATE-2 ALUMINUM HYDROXIDE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER BABASSU OIL SODIUM CHLORIDE STEARIC ACID POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CALCIUM STEARATE DISTEARDIMONIUM HECTORITE TRIETHOXYCAPRYLYLSILANE SODIUM BENZOATE POTASSIUM SORBATE TOCOPHEROL POLYHYDROXYSTEARIC ACID (2300 MW) SUNFLOWER OIL ETHYLHEXYL PALMITATE ISOPROPYL MYRISTATE ISOSTEARIC ACID LECITHIN, SOYBEAN EDETATE DISODIUM ANHYDROUS CYCLOMETHICONE 5 POLYGLYCERYL-3 PENTARICINOLEATE KAOLIN CYCLOMETHICONE 4 PHENOXYETHANOL HYALURONATE SODIUM ETHYLHEXYLGLYCERIN HYALURONIC ACID FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 34N medium neutral TITANIUM DIOXIDE AND ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER PHENYL TRIMETHICONE BUTYLENE GLYCOL DIMETHICONE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE BUTYLOCTYL SALICYLATE CYCLOMETHICONE 6 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) BIS-DIGLYCERYL POLYACYLADIPATE-2 ALUMINUM HYDROXIDE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER BABASSU OIL SODIUM CHLORIDE STEARIC ACID POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CALCIUM STEARATE DISTEARDIMONIUM HECTORITE TRIETHOXYCAPRYLYLSILANE SODIUM BENZOATE POTASSIUM SORBATE TOCOPHEROL POLYHYDROXYSTEARIC ACID (2300 MW) SUNFLOWER OIL ETHYLHEXYL PALMITATE ISOPROPYL MYRISTATE ISOSTEARIC ACID LECITHIN, SOYBEAN EDETATE DISODIUM ANHYDROUS CYCLOMETHICONE 5 POLYGLYCERYL-3 PENTARICINOLEATE KAOLIN CYCLOMETHICONE 4 PHENOXYETHANOL HYALURONATE SODIUM ETHYLHEXYLGLYCERIN HYALURONIC ACID FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 44S tan sand TITANIUM DIOXIDE AND ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER PHENYL TRIMETHICONE BUTYLENE GLYCOL DIMETHICONE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE BUTYLOCTYL SALICYLATE CYCLOMETHICONE 6 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) BIS-DIGLYCERYL POLYACYLADIPATE-2 ALUMINUM HYDROXIDE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER BABASSU OIL SODIUM CHLORIDE STEARIC ACID POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CALCIUM STEARATE DISTEARDIMONIUM HECTORITE TRIETHOXYCAPRYLYLSILANE SODIUM BENZOATE POTASSIUM SORBATE TOCOPHEROL POLYHYDROXYSTEARIC ACID (2300 MW) SUNFLOWER OIL ETHYLHEXYL PALMITATE ISOPROPYL MYRISTATE ISOSTEARIC ACID LECITHIN, SOYBEAN EDETATE DISODIUM ANHYDROUS CYCLOMETHICONE 5 POLYGLYCERYL-3 PENTARICINOLEATE KAOLIN CYCLOMETHICONE 4 PHENOXYETHANOL HYALURONATE SODIUM ETHYLHEXYLGLYCERIN HYALURONIC ACID FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 52N deep neutral TITANIUM DIOXIDE AND ZINC OXIDE TITANIUM DIOXIDE TITANIUM DIOXIDE ZINC OXIDE ZINC OXIDE WATER PHENYL TRIMETHICONE BUTYLENE GLYCOL DIMETHICONE BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE BUTYLOCTYL SALICYLATE CYCLOMETHICONE 6 CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2) BIS-DIGLYCERYL POLYACYLADIPATE-2 ALUMINUM HYDROXIDE METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER BABASSU OIL SODIUM CHLORIDE STEARIC ACID POLYGLYCERYL-4 ISOSTEARATE HEXYL LAURATE DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) CALCIUM STEARATE DISTEARDIMONIUM HECTORITE TRIETHOXYCAPRYLYLSILANE SODIUM BENZOATE POTASSIUM SORBATE TOCOPHEROL POLYHYDROXYSTEARIC ACID (2300 MW) SUNFLOWER OIL ETHYLHEXYL PALMITATE ISOPROPYL MYRISTATE ISOSTEARIC ACID LECITHIN, SOYBEAN EDETATE DISODIUM ANHYDROUS CYCLOMETHICONE 5 POLYGLYCERYL-3 PENTARICINOLEATE KAOLIN CYCLOMETHICONE 4 PHENOXYETHANOL HYALURONATE SODIUM ETHYLHEXYLGLYCERIN HYALURONIC ACID FERRIC OXIDE YELLOW FERRIC OXIDE RED FERROSOFERRIC OXIDE"
],
"spl_unclassified_section": [
"Drug Facts",
"Dist. by tarte, Inc. New York, NY 10018."
],
"active_ingredient": [
"Active Ingredients Purpose Titanium Dioxide 7.47% Sunscreen Zinc Oxide 4.75% Sunscreen"
],
"active_ingredient_table": [
"<table width=\"55%\"><col width=\"85%\" align=\"left\" valign=\"bottom\"/><col width=\"15%\" align=\"right\" valign=\"bottom\"/><thead><tr><th><content styleCode=\"italics\">Active Ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Titanium Dioxide 7.47%</td><td>Sunscreen</td></tr><tr><td>Zinc Oxide 4.75%</td><td>Sunscreen</td></tr></tbody></table>"
],
"purpose": [
"Active Ingredients Purpose Titanium Dioxide 7.47% Sunscreen Zinc Oxide 4.75% Sunscreen"
],
"purpose_table": [
"<table width=\"55%\"><col width=\"85%\" align=\"left\" valign=\"bottom\"/><col width=\"15%\" align=\"right\" valign=\"bottom\"/><thead><tr><th><content styleCode=\"italics\">Active Ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>Titanium Dioxide 7.47%</td><td>Sunscreen</td></tr><tr><td>Zinc Oxide 4.75%</td><td>Sunscreen</td></tr></tbody></table>"
],
"indications_and_usage": [
"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": [
"Warnings For external use only. Stop use and ask doctor if rash occurs. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Keep out of the reach of children . If swallowed, get medical help or contact a Poison Control Center right away."
],
"stop_use": [
"Stop use and ask doctor if rash occurs."
],
"do_not_use": [
"Do not use on damaged or broken skin."
],
"when_using": [
"When using this product keep out of eyes. Rinse with water to remove."
],
"keep_out_of_reach_of_children": [
"Keep out of the reach of children . If swallowed, get medical help or contact a Poison Control Center right away."
],
"dosage_and_administration": [
"Directions Shake before use. 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: \u2013 Limit time in the sun, especially from 10 a.m.-2 p.m. \u2013 Wear long-sleeved shirts, pants, hats and sunglasses"
],
"storage_and_handling": [
"Other information Protect the product in this container from excessive heat and direct sunlight. You may report a serious adverse reaction to: tarte c/o Report Reaction, LLC, P.O. Box 22, Plainsboro, NJ 08536-0222."
],
"inactive_ingredient": [
"Inactive Ingredients Water/Aqua/Eau, phenyl trimethicone, butylene glycol, dimethicone, butylene glycol dicaprylate/dicaprate, butyloctyl salicylate, cyclohexasiloxane, cetyl PEG/PPG-10/1 dimethicone, bis-diglyceryl polyacyladipate-2, aluminum hydroxide, methyl methacrylate crosspolymer, orbignya oleifera seed oil, sodium chloride, polypropylsilsesquioxane, stearic acid, polyglyceryl-4 isostearate, hexyl laurate, dimethicone/vinyl dimethicone crosspolymer, calcium stearate, disteardimonium hectorite, triethoxycaprylylsilane, sodium benzoate, potassium sorbate, tocopherol, polyhydroxystearic acid, helianthus annuus (sunflower) seed oil, ethylhexyl palmitate, isopropyl myristate, isostearic acid, lecithin, disodium EDTA, polyglyceryl-3 polyricinoleate, kaolin, phenoxyethanol, sodium hyaluronate, ethylhexylglycerin, hydrolyzed hyaluronic acid, titanium dioxide (CI 77891), iron oxides (CI 77491, CI 77492, CI 77499). EX100FL000712."
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 13N fair neutral FOUNDCEALER\u2122 tarte high-performance naturals\u2122 foundcealer\u2122 multi-tasking foundation Broad Spectrum SPF 20 Sunscreen net 10 mL / 0.33 Fl. Oz. PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 13N fair neutral",
"PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 22N light neutral FOUNDCEALER\u2122 tarte high-performance naturals\u2122 foundcealer\u2122 multi-tasking foundation Broad Spectrum SPF 20 Sunscreen net 10 mL / 0.33 Fl. Oz. PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 22N light neutral",
"PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 27N light-medium neutral FOUNDCEALER\u2122 tarte high-performance naturals\u2122 foundcealer\u2122 multi-tasking foundation Broad Spectrum SPF 20 Sunscreen net 10 mL / 0.33 Fl. Oz. PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 27N light-medium neutral",
"PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 34N medium neutral FOUNDCEALER\u2122 tarte high-performance naturals\u2122 foundcealer\u2122 multi-tasking foundation Broad Spectrum SPF 20 Sunscreen net 10 mL / 0.33 Fl. Oz. PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 34N medium neutral",
"PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 44S tan sand FOUNDCEALER\u2122 tarte high-performance naturals\u2122 foundcealer\u2122 multi-tasking foundation Broad Spectrum SPF 20 Sunscreen net 10 mL / 0.33 Fl. Oz. PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 44S tan sand",
"PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 52N deep neutral FOUNDCEALER\u2122 tarte high-performance naturals\u2122 foundcealer\u2122 multi-tasking foundation Broad Spectrum SPF 20 Sunscreen net 10 mL / 0.33 Fl. Oz. PRINCIPAL DISPLAY PANEL - 10 mL Bottle Carton - 52N deep neutral"
],
"set_id": "f5d54e9d-4963-419a-a091-bdbd1decd2b8",
"id": "ff5bd785-d7c5-45ca-9f17-0e2a6f4ab644",
"effective_time": "20231219",
"version": "2",
"openfda": {
"application_number": [
"M020"
],
"brand_name": [
"foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 13N fair neutral",
"foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 22N light neutral",
"foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 27N light-medium neutral",
"foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 34N medium neutral",
"foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 44S tan sand",
"foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 52N deep neutral"
],
"generic_name": [
"TITANIUM DIOXIDE AND ZINC OXIDE"
],
"manufacturer_name": [
"Tarte, Inc."
],
"product_ndc": [
"51060-287",
"51060-288",
"51060-289",
"51060-290",
"51060-291",
"51060-292"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"TOPICAL"
],
"substance_name": [
"TITANIUM DIOXIDE",
"ZINC OXIDE"
],
"spl_id": [
"ff5bd785-d7c5-45ca-9f17-0e2a6f4ab644"
],
"spl_set_id": [
"f5d54e9d-4963-419a-a091-bdbd1decd2b8"
],
"package_ndc": [
"51060-287-01",
"51060-288-01",
"51060-289-01",
"51060-290-01",
"51060-291-01",
"51060-292-01"
],
"is_original_packager": [
true
],
"unii": [
"15FIX9V2JP",
"SOI2LOH54Z"
]
}
}