SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5, SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Rose 5, SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Golden 5
Generic: OCTINOXATE AND TITANIUM DIOXIDE
Basic Information
Manufacturer
SHISEIDO AMERICAS CORPORATION
Product Type
HUMAN OTC DRUG
Route of Administration
TOPICAL
FDA Set ID
66c22f17-5418-42ff-97b2-33fa10f5eac3
Purpose
Active ingredients Purpose OCTINOXATE 2.9 % Sunscreen TITANIUM DIOXIDE 2.4 % 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
Warnings
Warnings For external use only Do not use on damaged or broken skin When using this product keep out of eyes.
Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Flammable; Do not use near heat, flam or white smoking.
Rinse with water to remove.
Stop use and ask a doctor if rash occurs.
Keep out of reach of children.
If product is swallowed, get medical help or contact a Poison Control Center right away.
Flammable; Do not use near heat, flam or white smoking.
Technical Data
{
"spl_product_data_elements": [
"SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5 OCTINOXATE and TITANIUM DIOXIDE DIMETHICONE WATER FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MEDIUM-CHAIN TRIGLYCERIDES DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE MAGNESIUM MYRISTATE NYLON-12 DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE STEARIC ACID GLYCERIN BUTYLATED HYDROXYTOLUENE ALCOHOL BUTYLENE GLYCOL .ALPHA.-TOCOPHEROL METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM WHOLE PHENOXYETHANOL HYPERICUM ERECTUM FLOWERING TOP TALC MICA DIMETHICONE/PEG-10/15 CROSSPOLYMER SILICON DIOXIDE ALUMINUM OXIDE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) D&C RED NO. 27 DIISOSTEARYL MALATE GLYCERYL DIISOSTEARATE DIPROPYLENE GLYCOL OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Rose 5 OCTINOXATE and TITANIUM DIOXIDE DIMETHICONE WATER MEDIUM-CHAIN TRIGLYCERIDES DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MAGNESIUM MYRISTATE NYLON-12 DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE STEARIC ACID GLYCERIN BUTYLATED HYDROXYTOLUENE ALCOHOL BUTYLENE GLYCOL .ALPHA.-TOCOPHEROL METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM WHOLE PHENOXYETHANOL HYPERICUM ERECTUM FLOWERING TOP TALC MICA DIMETHICONE/PEG-10/15 CROSSPOLYMER SILICON DIOXIDE ALUMINUM OXIDE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) D&C RED NO. 27 DIISOSTEARYL MALATE GLYCERYL DIISOSTEARATE DIPROPYLENE GLYCOL OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Golden 5 OCTINOXATE and TITANIUM DIOXIDE DIMETHICONE WATER FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE MEDIUM-CHAIN TRIGLYCERIDES DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE MAGNESIUM MYRISTATE NYLON-12 DISTEARDIMONIUM HECTORITE ALUMINUM HYDROXIDE STEARIC ACID GLYCERIN BUTYLATED HYDROXYTOLUENE ALCOHOL BUTYLENE GLYCOL .ALPHA.-TOCOPHEROL METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7) THYMUS SERPYLLUM WHOLE PHENOXYETHANOL HYPERICUM ERECTUM FLOWERING TOP TALC MICA DIMETHICONE/PEG-10/15 CROSSPOLYMER SILICON DIOXIDE ALUMINUM OXIDE POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) D&C RED NO. 27 DIISOSTEARYL MALATE GLYCERYL DIISOSTEARATE DIPROPYLENE GLYCOL OCTINOXATE OCTINOXATE TITANIUM DIOXIDE TITANIUM DIOXIDE"
],
"spl_unclassified_section": [
"Drug Facts"
],
"active_ingredient": [
"Active ingredients Purpose OCTINOXATE 2.9 % Sunscreen TITANIUM DIOXIDE 2.4 % Sunscreen"
],
"active_ingredient_table": [
"<table width=\"60%\"><col width=\"80%\" align=\"left\" valign=\"top\"/><col width=\"20%\" align=\"center\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>OCTINOXATE 2.9 %</td><td>Sunscreen</td></tr><tr><td>TITANIUM DIOXIDE 2.4 %</td><td>Sunscreen</td></tr></tbody></table>"
],
"purpose": [
"Active ingredients Purpose OCTINOXATE 2.9 % Sunscreen TITANIUM DIOXIDE 2.4 % Sunscreen"
],
"purpose_table": [
"<table width=\"60%\"><col width=\"80%\" align=\"left\" valign=\"top\"/><col width=\"20%\" align=\"center\" valign=\"top\"/><thead><tr><th><content styleCode=\"italics\">Active ingredients</content></th><th><content styleCode=\"italics\">Purpose</content></th></tr></thead><tbody><tr><td>OCTINOXATE 2.9 %</td><td>Sunscreen</td></tr><tr><td>TITANIUM DIOXIDE 2.4 %</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 Do not use on damaged or broken skin When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash occurs. Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away. Flammable; Do not use near heat, flam or white smoking."
],
"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."
],
"stop_use": [
"Stop use and ask a doctor if rash occurs."
],
"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."
],
"dosage_and_administration": [
"Directions For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply at least every two hours 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 a.m. \u2013 2 p.m. wear long-sleeve shirts, pants, hats, and sunglasses children under 6 months: Ask a doctor"
],
"inactive_ingredient": [
"Inactive Ingredients DIMETHICONE\u2219WATER\u2219TRIFLUOROPROPYLDIMETHYL/TRIMETHYLSILOXYSILICATE\u2219CAPRYLIC/CAPRIC TRIGLYCERIDE\u2219DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER\u2219PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE\u2219SD ALCOHOL 40-B\u2219MAGNESIUM MYRISTATE\u2219NYLON-12\u2219DIPHENYL DIMETHICONE/VINYL DIPHENYL DIMETHICONE/SILSESQUIOXANE CROSSPOLYMER\u2219DISTEARDIMONIUM HECTORITE\u2219POLYQUATERNIUM-51\u2219THYMUS SERPILLUM EXTRACT\u2219ALUMINUM HYDROXIDE\u2219ALUMINUM DISTEARATE\u2219POLYSILICONE-2\u2219GLYCERIN\u2219BHT\u2219ALCOHOL\u2219BUTYLENE GLYCOL\u2219TOCOPHEROL\u2219METHYL METHACRYLATE CROSSPOLYMER\u2219HYPERICUM ERECTUM FLOWER/LEAF/STEM EXTRACT\u2219TALC\u2219DIMETHICONE/PEG-10/15 CROSSPOLYMER\u2219SILICA\u2219ALUMINA\u2219POLYMETHYLSILSESQUIOXANE\u2219DIISOSTEARYL MALATE\u2219GLYCERYL DIISOSTEARATE\u2219DIPROPYLENE GLYCOL\u2219PHENOXYETHANOL\u2219FRAGRANCE\u2219TITANIUM DIOXIDE\u2219IRON OXIDES\u2219MICA\u2219RED 27\u2219"
],
"storage_and_handling": [
"Other information Protect this product in this container from excessive heat and direct sun."
],
"questions": [
"Questions or comments? Call toll free 1-800-906-7503"
],
"package_label_principal_display_panel": [
"PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 5 SHISEIDO GINZA TOKYO SYNCHRO SKIN Lasting Liquid Foundation Oil Free BROAD SPECTRUM SPF 20 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Neutral 5",
"PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 5 SHISEIDO GINZA TOKYO SYNCHRO SKIN Lasting Liquid Foundation Oil Free BROAD SPECTRUM SPF 20 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Rose 5",
"PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 5 SHISEIDO GINZA TOKYO SYNCHRO SKIN Lasting Liquid Foundation Oil Free BROAD SPECTRUM SPF 20 Sunscreen 30mL 1 FL. OZ. PRINCIPAL DISPLAY PANEL - 30 mL Bottle Carton - Golden 5"
],
"set_id": "66c22f17-5418-42ff-97b2-33fa10f5eac3",
"id": "47b9b5e0-84a4-bb9d-e063-6294a90a2157",
"effective_time": "20260106",
"version": "6",
"openfda": {
"application_number": [
"M020"
],
"brand_name": [
"SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5",
"SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Rose 5",
"SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Golden 5"
],
"generic_name": [
"OCTINOXATE AND TITANIUM DIOXIDE"
],
"manufacturer_name": [
"SHISEIDO AMERICAS CORPORATION"
],
"product_ndc": [
"58411-624",
"58411-625",
"58411-626"
],
"product_type": [
"HUMAN OTC DRUG"
],
"route": [
"TOPICAL"
],
"substance_name": [
"OCTINOXATE",
"TITANIUM DIOXIDE"
],
"spl_id": [
"47b9b5e0-84a4-bb9d-e063-6294a90a2157"
],
"spl_set_id": [
"66c22f17-5418-42ff-97b2-33fa10f5eac3"
],
"package_ndc": [
"58411-624-10",
"58411-625-10",
"58411-626-10"
],
"is_original_packager": [
true
],
"unii": [
"15FIX9V2JP",
"4Y5P7MUD51"
]
}
}