FDA.reportPublic FDA data

3LAB WW DAY SPF40 BROAD SPECTRUM

Manufacturer
3LAB, INC
Effective date
2024-12-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:49:01

Label at a glance#

Product3LAB WW DAY SPF40 BROAD SPECTRUM
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure9 sections

Indications and uses

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

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 Apply to all skin exposed to the sun

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Homosalate 10%

Octisalate 5%

Avobenzone 3.0%

Octocrylene 2.6%

OTC - PURPOSE SECTION

Purpose

Sunscreen

USES

INDICATIONS & USAGE SECTION

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 SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin.

OTC - WHEN USING SECTION

When using this productkeep out of eyes. Rinse with water to remove

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

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
  • Apply to all skin exposed to the sun

Bottle Packaging Label

COMPONENTS

Bottle Packaging LabelBottle Packaging Label

OTHER INFORMATION

OTHER SAFETY INFORMATION

Other information

Protect this product from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Isododecane, Dimethicone/ Bis-Isobutyl PPG-20 Crosspolymer, Ethylhexyl Palmitate, Butyloctyl Salicylate, Caprylyl Methicone, Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, Dimethicone/Vinyl Dimethicone Crosspolymer, Water, Glycerin, PEG-12 Dimethicone/PPG-20 Crosspolymer, Silica, Melia Azadirachta Extract, Sesamum Indicum (Sesame) Seed Oil, Moringa Oleifera Seed Oil, Olea Europaea (Olive) Fruit Oil, Oligopeptide-4, Oligopeptide-5, sh-Polypeptide-7, Acetyl Heptapeptide-9, Isomalt, Vitis Vinifera (Grape) Fruit Cell Extract, Malus Domestica Fruit Cell Culture Extract, Lecithin, Xanthan Gum, Hydrolyzed Pea Protein, Squalane, Phytosterols, Ceramide NP, Butyrospermum Parkii (Shea) Butter, Tocopherol, Tocopheryl Acetate, Diacetyl Boldine, Phenoxyethanol, Dimethyl Isosorbide, Sodium Phosphate, Disodium EDTA, Colloidal Gold, Citrus Aurantium Dulcis (Orange) Peel Oil, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Lavandula Hybrida Oil

Outer Packaging Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Packaging LabelOuter Packaging Label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76159-205-003LAB WW DAY SPF40 BROAD SPECTRUM50 mg in 1 BOTTLECREAM501
76159-205-003LAB WW DAY SPF40 BROAD SPECTRUM1 in 1 CARTONCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76159-2053LAB WW DAY SPF40 BROAD SPECTRUM (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [3LAB, INC]1Current NDC, 2 package rows20241228_2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e.zip

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 · 42 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76159-20576159-205-00

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

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
3LAB WW DAY SPF40 BROAD SPECTRUMHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE3LAB, INC2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e2024-12-26WarningsExact identifier
ndc (package): 76159-205-00
ndc (product): 76159-205
ndc11 (package): 76159020500
spl id: 2a2f8479-05b8-bc28-e063-6294a90a85aa
spl set id: 2a2f5f9a-4e2f-4bbb-e063-6294a90ab99e