{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-10-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "spl_product_data_elements": [ "IMPECCABLE SKIN - IVORY Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF WATER MEDIUM-CHAIN TRIGLYCERIDES C13-15 ALKANE GLYCERIN LAUROYL LYSINE POLYGLYCERYL-2 OLEATE POLYHYDROXYSTEARIC ACID STEARATE ALKYL (C12-15) BENZOATE STEARALKONIUM HECTORITE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE DIPALMITOYL HYDROXYPROLINE TETRAHEXYLDECYL ASCORBATE TOCOPHEROL EUROPEAN ELDERBERRY KAPPAPHYCUS ALVAREZII TARA SPINOSA FRUIT POD MELANIN SYNTHETIC (TYROSINE, PEROXIDE) .ALPHA.-BISABOLOL, (+/-)- HYALURONIC ACID GREEN TEA LEAF OMEGA-3 FATTY ACIDS POLYGLYCERYL-2 STEARATE BIFIDOBACTERIUM ANIMALIS LACTIS COCONUT ETHYLHEXYLGLYCERIN SODIUM CHLORIDE PROPYLENE CARBONATE ISOPROPYL TITANIUM TRIISOSTEARATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW IMPECCABLE SKIN - BUFF Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF WATER MEDIUM-CHAIN TRIGLYCERIDES C13-15 ALKANE GLYCERIN LAUROYL LYSINE POLYGLYCERYL-2 OLEATE POLYHYDROXYSTEARIC ACID STEARATE ALKYL (C12-15) BENZOATE STEARALKONIUM HECTORITE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE DIPALMITOYL HYDROXYPROLINE TETRAHEXYLDECYL ASCORBATE TOCOPHEROL EUROPEAN ELDERBERRY KAPPAPHYCUS ALVAREZII TARA SPINOSA FRUIT POD MELANIN SYNTHETIC (TYROSINE, PEROXIDE) .ALPHA.-BISABOLOL, (+/-)- HYALURONIC ACID GREEN TEA LEAF OMEGA-3 FATTY ACIDS POLYGLYCERYL-2 STEARATE BIFIDOBACTERIUM ANIMALIS LACTIS COCONUT ETHYLHEXYLGLYCERIN SODIUM CHLORIDE PROPYLENE CARBONATE ISOPROPYL TITANIUM TRIISOSTEARATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW IMPECCABLE SKIN - SAND Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF WATER MEDIUM-CHAIN TRIGLYCERIDES C13-15 ALKANE GLYCERIN LAUROYL LYSINE POLYGLYCERYL-2 OLEATE POLYHYDROXYSTEARIC ACID STEARATE ALKYL (C12-15) BENZOATE STEARALKONIUM HECTORITE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE DIPALMITOYL HYDROXYPROLINE TETRAHEXYLDECYL ASCORBATE TOCOPHEROL EUROPEAN ELDERBERRY KAPPAPHYCUS ALVAREZII TARA SPINOSA FRUIT POD MELANIN SYNTHETIC (TYROSINE, PEROXIDE) .ALPHA.-BISABOLOL, (+/-)- HYALURONIC ACID GREEN TEA LEAF OMEGA-3 FATTY ACIDS POLYGLYCERYL-2 STEARATE BIFIDOBACTERIUM ANIMALIS LACTIS COCONUT ETHYLHEXYLGLYCERIN SODIUM CHLORIDE PROPYLENE CARBONATE ISOPROPYL TITANIUM TRIISOSTEARATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW IMPECCABLE SKIN - TAN Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF WATER MEDIUM-CHAIN TRIGLYCERIDES C13-15 ALKANE GLYCERIN LAUROYL LYSINE POLYGLYCERYL-2 OLEATE POLYHYDROXYSTEARIC ACID STEARATE ALKYL (C12-15) BENZOATE STEARALKONIUM HECTORITE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE DIPALMITOYL HYDROXYPROLINE TETRAHEXYLDECYL ASCORBATE TOCOPHEROL EUROPEAN ELDERBERRY KAPPAPHYCUS ALVAREZII TARA SPINOSA FRUIT POD MELANIN SYNTHETIC (TYROSINE, PEROXIDE) .ALPHA.-BISABOLOL, (+/-)- HYALURONIC ACID GREEN TEA LEAF OMEGA-3 FATTY ACIDS POLYGLYCERYL-2 STEARATE BIFIDOBACTERIUM ANIMALIS LACTIS COCONUT ETHYLHEXYLGLYCERIN SODIUM CHLORIDE PROPYLENE CARBONATE ISOPROPYL TITANIUM TRIISOSTEARATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW IMPECCABLE SKIN - BRONZE Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF WATER MEDIUM-CHAIN TRIGLYCERIDES C13-15 ALKANE GLYCERIN LAUROYL LYSINE POLYGLYCERYL-2 OLEATE POLYHYDROXYSTEARIC ACID STEARATE ALKYL (C12-15) BENZOATE STEARALKONIUM HECTORITE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE DIPALMITOYL HYDROXYPROLINE TETRAHEXYLDECYL ASCORBATE TOCOPHEROL EUROPEAN ELDERBERRY KAPPAPHYCUS ALVAREZII TARA SPINOSA FRUIT POD MELANIN SYNTHETIC (TYROSINE, PEROXIDE) .ALPHA.-BISABOLOL, (+/-)- HYALURONIC ACID GREEN TEA LEAF OMEGA-3 FATTY ACIDS POLYGLYCERYL-2 STEARATE BIFIDOBACTERIUM ANIMALIS LACTIS COCONUT ETHYLHEXYLGLYCERIN SODIUM CHLORIDE PROPYLENE CARBONATE ISOPROPYL TITANIUM TRIISOSTEARATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW IMPECCABLE SKIN - NUDE Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF WATER MEDIUM-CHAIN TRIGLYCERIDES C13-15 ALKANE GLYCERIN LAUROYL LYSINE POLYGLYCERYL-2 OLEATE POLYHYDROXYSTEARIC ACID STEARATE ALKYL (C12-15) BENZOATE STEARALKONIUM HECTORITE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE DIPALMITOYL HYDROXYPROLINE TETRAHEXYLDECYL ASCORBATE TOCOPHEROL EUROPEAN ELDERBERRY KAPPAPHYCUS ALVAREZII TARA SPINOSA FRUIT POD MELANIN SYNTHETIC (TYROSINE, PEROXIDE) .ALPHA.-BISABOLOL, (+/-)- HYALURONIC ACID GREEN TEA LEAF OMEGA-3 FATTY ACIDS POLYGLYCERYL-2 STEARATE BIFIDOBACTERIUM ANIMALIS LACTIS COCONUT ETHYLHEXYLGLYCERIN SODIUM CHLORIDE PROPYLENE CARBONATE ISOPROPYL TITANIUM TRIISOSTEARATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW IMPECCABLE SKIN - MOCHA Zinc Oxide ZINC OXIDE ZINC OXIDE ALOE VERA LEAF WATER MEDIUM-CHAIN TRIGLYCERIDES C13-15 ALKANE GLYCERIN LAUROYL LYSINE POLYGLYCERYL-2 OLEATE POLYHYDROXYSTEARIC ACID STEARATE ALKYL (C12-15) BENZOATE STEARALKONIUM HECTORITE LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE DIPALMITOYL HYDROXYPROLINE TETRAHEXYLDECYL ASCORBATE TOCOPHEROL EUROPEAN ELDERBERRY KAPPAPHYCUS ALVAREZII TARA SPINOSA FRUIT POD MELANIN SYNTHETIC (TYROSINE, PEROXIDE) .ALPHA.-BISABOLOL, (+/-)- HYALURONIC ACID GREEN TEA LEAF OMEGA-3 FATTY ACIDS POLYGLYCERYL-2 STEARATE BIFIDOBACTERIUM ANIMALIS LACTIS COCONUT ETHYLHEXYLGLYCERIN SODIUM CHLORIDE PROPYLENE CARBONATE ISOPROPYL TITANIUM TRIISOSTEARATE TITANIUM DIOXIDE FERROSOFERRIC OXIDE FERRIC OXIDE RED FERRIC OXIDE YELLOW" ], "spl_unclassified_section": [ "Drug Facts" ], "active_ingredient": [ "Active Ingredient Zinc Oxide 15%" ], "purpose": [ "Purpose Sunscreen" ], "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 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." ], "do_not_use": [ "Do not use on damaged or broken skin" ], "stop_use": [ "Stop use and ask a doctor if rash occurs" ], "when_using": [ "When using this product keep out of eyes. Rinse with water to remove." ], "keep_out_of_reach_of_children": [ "Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away." ], "dosage_and_administration": [ "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 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" ], "inactive_ingredient": [ "Inactive Ingredients Aloe Barbadensis Leaf Juice, Purified Water, Caprylic/Capric Triglyceride, C13-15 Alkane, Glycerin, Lauroyl Lysine, Polyglyceryl-2 Oleate, Polyhydroxystearic Acid, C12-15 Alkyl Benzoate, Stearalkonium Hectorite, Leuconostoc/Radish Root Ferment Filtrate, Dipalmitoyl Hydroxyproline, Tetrahexyldecyl Ascorbate, Tocopherol, Sambucus Nigra Fruit Extract, Kappaphycus Alvarezii Extract, Caesalpinia Spinosa Fruit Extract, Melanin, Bisabolol, Hyaluronic Acid, Camellia Sinensis Leaf Extract, Phospholipids, Polyglyceryl-2 Stearate, Lactobacillus, Cocos Nucifera (Coconut) Fruit Extract, Ethylhexylglycerin, Sodium Chloride, Propylene Carbonate, Isopropyl Titanium Triisostearate, Titanium Dioxide (C.I.77891), Iron Oxides (C.I.77492, C.I. 77491, C.I.77499)" ], "storage_and_handling": [ "Other information protect the product in this container from excessive heat and direct sun" ], "package_label_principal_display_panel": [ "PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Ivory sun tegrity ® IMPECCABLE SKIN SUNSCREEN FOUNDATION BROAD SPECTRUM SPF 30 SPF 30 NON-NANO ZINC OXIDE MEDIUM COVERAGE CC CREAM SATIN FINISH Peptides & Vitamins C + E Blue Light Protection Oil Free | Vegan | Reef Friendly NET WT 2 OZ (56.7 g) PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Ivory", "PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Buff sun tegrity ® IMPECCABLE SKIN SUNSCREEN FOUNDATION BROAD SPECTRUM SPF 30 SPF 30 NON-NANO ZINC OXIDE MEDIUM COVERAGE CC CREAM SATIN FINISH Peptides & Vitamins C + E Blue Light Protection Oil Free | Vegan | Reef Friendly NET WT 2 OZ (56.7 g) PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Buff", "PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Sand sun tegrity ® IMPECCABLE SKIN SUNSCREEN FOUNDATION BROAD SPECTRUM SPF 30 SPF 30 NON-NANO ZINC OXIDE MEDIUM COVERAGE CC CREAM SATIN FINISH Peptides & Vitamins C + E Blue Light Protection Oil Free | Vegan | Reef Friendly NET WT 2 OZ (56.7 g) PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Sand", "PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Tan sun tegrity ® IMPECCABLE SKIN SUNSCREEN FOUNDATION BROAD SPECTRUM SPF 30 SPF 30 NON-NANO ZINC OXIDE MEDIUM COVERAGE CC CREAM SATIN FINISH Peptides & Vitamins C + E Blue Light Protection Oil Free | Vegan | Reef Friendly NET WT 2 OZ (56.7 g) PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Tan", "PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Bronze sun tegrity ® IMPECCABLE SKIN SUNSCREEN FOUNDATION BROAD SPECTRUM SPF 30 SPF 30 NON-NANO ZINC OXIDE MEDIUM COVERAGE CC CREAM SATIN FINISH Peptides & Vitamins C + E Blue Light Protection Oil Free | Vegan | Reef Friendly NET WT 2 OZ (56.7 g) PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Bronze", "PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Nude sun tegrity ® IMPECCABLE SKIN SUNSCREEN FOUNDATION BROAD SPECTRUM SPF 30 SPF 30 NON-NANO ZINC OXIDE MEDIUM COVERAGE CC CREAM SATIN FINISH Peptides & Vitamins C + E Blue Light Protection Oil Free | Vegan | Reef Friendly NET WT 2 OZ (56.7 g) PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Nude", "PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Mocha sun tegrity ® IMPECCABLE SKIN SUNSCREEN FOUNDATION BROAD SPECTRUM SPF 30 SPF 30 NON-NANO ZINC OXIDE MEDIUM COVERAGE CC CREAM SATIN FINISH Peptides & Vitamins C + E Blue Light Protection Oil Free | Vegan | Reef Friendly NET WT 2 OZ (56.7 g) PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label - Mocha" ], "set_id": "98a7896e-4b03-4184-ac2e-6b49e47c0bc4", "id": "f0219616-bbcb-4d7e-a1f7-0cbc2cf6efe9", "effective_time": "20241121", "version": "3", "openfda": { "application_number": [ "M020" ], "brand_name": [ "IMPECCABLE SKIN - IVORY", "IMPECCABLE SKIN - BUFF", "IMPECCABLE SKIN - SAND", "IMPECCABLE SKIN - TAN", "IMPECCABLE SKIN - BRONZE", "IMPECCABLE SKIN - NUDE", "IMPECCABLE SKIN - MOCHA" ], "generic_name": [ "ZINC OXIDE" ], "manufacturer_name": [ "Synchronicity Spa, Inc. DBA Suntegrity" ], "product_ndc": [ "69949-151", "69949-152", "69949-153", "69949-154", "69949-155", "69949-156", "69949-157" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "ZINC OXIDE" ], "spl_id": [ "f0219616-bbcb-4d7e-a1f7-0cbc2cf6efe9" ], "spl_set_id": [ "98a7896e-4b03-4184-ac2e-6b49e47c0bc4" ], "package_ndc": [ "69949-151-01", "69949-152-01", "69949-153-01", "69949-154-01", "69949-155-01", "69949-156-01", "69949-157-01" ], "is_original_packager": [ true ], "unii": [ "SOI2LOH54Z" ] } } ] }