FDA.reportPublic FDA data

NDC 21839-620-01 - COOLA Full Spectrum 360 Sun Silk Drops SPF 30

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
21839-620
Requested NDC
21839-620-01
Package NDCs from labels
21839-620-01, 21839-620-02, 21839-620-03, 21839-620-04
Manufacturer
Gordon Laboratories, Inc. | GORDON LABORATORIES,INC
Effective date
2019-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
WATER - Gordon Laboratories, Inc. | GORDON LABORATORIES,INCGordon Laboratories, Inc. | GORDON LABORATORIES,INC2019-12-18HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21839-620-022021-01-29C16284748780-1ba0f9c33-5e26-a910-e053-dadaa90a0b85COOLA Full Spectrum 360 Sun Silk Drops SPF 30
21839-620-042021-01-29C16284748780-1ba0f9c33-5e26-a910-e053-dadaa90a0b85COOLA Full Spectrum 360 Sun Silk Drops SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21839-620-01COOLA Full Spectrum 360 Sun Silk DropsSPF 305 mL in 1 BOTTLELIQUID51
21839-620-02COOLA Full Spectrum 360 Sun Silk DropsSPF 301 in 1 NOT APPLICABLELIQUID11
21839-620-03COOLA Full Spectrum 360 Sun Silk DropsSPF 3030 mL in 1 BOTTLELIQUID301
21839-620-04COOLA Full Spectrum 360 Sun Silk DropsSPF 301 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21839-620COOLA FULL SPECTRUM 360 SUN SILK DROPS SPF 30 (AVOBENZONE,HOMOSALATE, OCTISALATE,OCTOCRYLENE) LIQUID [GORDON LABORATORIES, INC.]1Legacy NDC, 4 package rows20191224_9a03c1f7-098e-035d-e053-2a95a90a1fef.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 59 of 203 · 4,050 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Coppertone Sport Sunscreen Lip Balm SPF 30AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE,Beiersdorf Inc47bc6776-1130-0162-e063-6294a90a2adc2026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC088fa3cd-b9b8-d10b-e063-6394a90a7fd62026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
SPF 50 Florida Sun Defense Broad Spectrum SPF 50 Sunscreen Body OilHOMOSALATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.47c147a9-c4f4-ab82-e063-6394a90aaa5c2026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: 4X49Y0596W
PoutScreen Lip Treatment Love LetterAVOBENZONE, OCTINOXATE, OCTOCRYLENENAKED SUNDAYS PTY LTD47d22c6d-49fd-f97c-e063-6294a90a6ba12026-01-06WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Proctozone-GGLYCERINRising Pharma Holdings, Inc.8a5c8ad5-3619-4971-967d-165270a20bc82026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Proctozone GMaxGLYCERINRising Pharma Holdings, Inc.a13c2be6-d650-4b53-bddd-d55e92fe10c62026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Multi Food AntigensARSENICUM ALBUM, LYCOPODIUM CLAVATUM, PULSATILLA (PRATENSIS), ALLIUM CEPA, ALLIUM SATIVUM, ALMOND, APIUM GRAVEOLENS, BETA VULGARIS, BRASSICA OLERACEA VAR. ITALICA, BRAZIL, CACAO, CAPSICUM ANNUUM, CASHEW, CICER ARIETINUM, CITRUS LIMONUM, COCONUT, COFFEA TOSTA, COLLAGEN, CORN, CUCUMIS SATIVUS, ENGLISH WALNUT, GLYCINE MAX, HEART (BOVINE), HEART (SUIS), LAC VACCINUM, LACTUCA SATIVA, LYCOPERSICUM ESCULENTUM, ORANGE, OXALICUM ACIDUM, PEANUT, PECAN, PHASEOLUS, PHASEOLUS VULGARIS, RAPHANUS SATIVUS, SESAME,Energique, Inc.a289e8a7-1188-43be-b34b-fe6d5ee09d1c2026-01-06WarningsExact identifier
unii: D9108TZ9KG
Good Sense Hemorrhoidal Maximum Strength Pain ReliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUML. Perrigo Company1d6142b6-3746-46f1-99ec-4b19d26f056e2026-01-06WarningsExact identifier
unii: PDC6A3C0OX
Moisturizing Antioxidant SPF 50OCTINOXATE, OCTISALATE, HOMOSALATE, OXYBENZONE, ZINC OXIDETopiderm, Inc.727c14d3-ad26-4e8b-91f6-b7a5f07e4e2f2026-01-05WarningsExact identifier
unii: V06SV4M95S
unii: 4X49Y0596W
Sting Relief prep PadSTING RELIEF PREP PADSHENZHEN BENLIJU BIO-TECH CO.,LTD202c7b77-1a48-52a5-e063-6394a90a2eb22026-01-05WarningsExact identifier
unii: PDC6A3C0OX
Skin Cleaning Care WipesSKIN CLEANING CARE WIPESSHENZHEN BENLIJU BIO-TECH CO.,LTD203d7a95-65fe-ca65-e063-6294a90acc6e2026-01-05WarningsExact identifier
unii: PDC6A3C0OX
ORLASKIN HYDRATING SUNSCREENORLASKIN HYDRATING SUNSCREENGuangzhou Fantesy Biotechnology Co.,Ltd0808b0cd-2cfb-8554-e063-6294a90ad6c42026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228fab45-e0d2-f219-e063-6294a90a1ef62026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
HAWAIIAN TROPICAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC228055ec-ff59-4412-e063-6394a90abe142026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W
SHISEIDO BENEFIANCE WRINKLE SMOOTHING DAYAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION4bd99626-690b-49e8-8c42-a2e2dbca09bf2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
cle de peau BEAUTE LONG-LASTING HYDRATING VEILAVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONf04ece6c-66b6-48e9-8f6b-e898a538ba002026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
cle de peau BEAUTE BRIGHTENING ENHANCER VEILOCTINOXATE, OCTOCRYLENE, AND TITANIUM DIOXIDESHISEIDO AMERICAS CORPORATIONbb00d6d7-cc51-4fee-a0df-68bbd5bc50d62026-01-05WarningsExact identifier
unii: 5A68WGF6WM
cle de peau BEAUTE PROTECTIVE LIP TREATMENT SPF 25AVOBENZONE, OCTINOXATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATIONaddd9885-362c-4ce0-9a6e-759e71d8756c2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
cle de peau BEAUTE PROTECTIVE FORTIFYING nAVOBENZONE, OCTINOXATE, OCTOCRYLENE, AND OXYBENZONESHISEIDO AMERICAS CORPORATION65ca1240-6ee8-40c0-b62f-3597e0872c6e2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: G63QQF2NOX
Dominas Dark Spot UV Defense Sunscreen Broad Spectrum SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENELG H&H Co.,Ltd.098c0a9b-2b96-6be3-e063-6294a90a959a2026-01-05WarningsExact identifier
unii: 5A68WGF6WM
unii: V06SV4M95S
unii: G63QQF2NOX
unii: 4X49Y0596W

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.