FDA.reportPublic FDA data

3LAB WW DAY SPF40 BROAD SPECTRUM

Manufacturer
3LAB | COSMAX USA, Inc.(Cosmax USA, Corporation)
Effective date
2018-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:47:11

Label at a glance#

Product3LAB WW DAY SPF40 BROAD SPECTRUM
Active ingredientOCTISALATE, AVOBENZONE, HOMOSALATE, OCTOCRYLENE
Label structure2 sections

Label contents#

Full prescribing information#

Bottle Packaging Label

COMPONENTS

Bottle PackagingBottle Packaging

Outer Packaging Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Packaging LabelOuter Packaging Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76159-204-012023-07-31C16284748780-1f386c649-fa88-0266-e053-dadaa90a7c1a60a5dc14-3f82-8414-e053-2991aa0ad34a
76159-204-012023-01-30C16284748780-1f386c649-fa88-0266-e053-dadaa90a7c1a60a5dc14-3f82-8414-e053-2991aa0ad34a

DailyMed Biologic / Drug Substance Indexing#

Product, Base substance, Indexed substance code table
ProductBase substanceIndexed substance codeIndexed substanceApplicationIndexing SPLSPL versionEffective
RETACRITERYTHROPOIETIN64FS3BFH5W-EPBX-01epoetin alfa-epbxBLA1255458ba23d58-e94d-494e-84e7-b775aad9cfdf12018-05-15

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76159-20476159-204-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
LAVANDIN OIL9RES347CKGIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE)H895X08VNQIACT
ETHYLHEXYL PALMITATE2865993309IACT
AVOBENZONEG63QQF2NOXACTIB
DIMETHYL ISOSORBIDESA6A6V432SIACT
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMERO4I3UFO6ZFIACT
ISODODECANEA8289P68Y2IACT
GLYCERINPDC6A3C0OXIACT
EDETATE DISODIUM7FLD91C86KIACT
HOMOSALATEV06SV4M95SACTIB
TOCOPHEROLR0ZB2556P8IACT
SODIUM PHOSPHATESE337SVY37IACT
SQUALANEGW89575KF9IACT
ORANGE OILAKN3KSD11BIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
ERYTHROPOIETIN64FS3BFH5WIACT
SESAME OILQX10HYY4QVIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
XANTHAN GUMTTV12P4NEEIACT
MORINGA OLEIFERA SEED OILREM6A5QMC0IACT
ISOMALTS870P55O2WIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLYMETHYLSILSESQUIOXANE (11 MICRONS)Z570VEV8XKIACT
AZADIRACHTA INDICA BARKG580B439YIIACT
OCTOCRYLENE5A68WGF6WMACTIB
CERAMIDE 34370DF050BIACT
PEG-12 DIMETHICONE/PPG-20 CROSSPOLYMER965K72OQXOIACT
SHEA BUTTERK49155WL9YIACT
WINE GRAPE3GOV20705GIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
GOLD79Y1949PYOIACT
OLIVE OIL6UYK2W1W1EIACT
BERGAMOT OIL39W1PKE3JIIACT
MALUS DOMESTICA WHOLE04W636S1V3IACT
DIACETYL BOLDINE37727Z7M0IIACT
PHENOXYETHANOLHIE492ZZ3TIACT
LECITHIN, SOYBEAN1DI56QDM62IACT

Source Document#

Source XML

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
01b6a03e-0f49-239a-e063-6394a90af5e760a5dc14-3f82-8414-e053-2991aa0ad34a2023-07-30Exact identifier
spl set id: 60a5dc14-3f82-8414-e053-2991aa0ad34a

Reported adverse events (FAERS/openFDA)#

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