FDA.reportPublic FDA data

2000DL-CL30T

Manufacturer
Epic Laboratories, LLC
Effective date
2026-03-02
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:48:30

Label at a glance#

Product2000DL-CL30T
Active ingredientOctocrylene, AVOBENZONE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Avobenzone 3%

Octocrylene 8%

OTC - PURPOSE SECTION

Purpose:

Sunscreen

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 SECTION

WARNINGS: Skin Cancer/ Sking Aging Alert: Spending time in the sun

increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer and early skin aging.

For external use only.

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

Stop use and ask a doctor if irritation or rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • apply liberally 15 minutes before sun exposure
  • reapply:

​*after 80minutes of swimming or sweating * immediately after towel drying

*at least every 2 hours

*children under 6 months: Ask a doctor

DOSAGE & ADMINISTRATION 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.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, Acrylates/C10-30, Alkyl Acrylate cross polymer, Stearic Acid, Glyceryl Monostearate, Bis-Octyldodecyl Dimer Dillinoleate/Propanediol Copolymer, Sorbeth-2-Hexaoleate, Phenoxylethanol, Ethylhexylglycerin, Triethanolamine, Disodium EDTA.

OTHER SAFETY INFORMATION

*Protect product from excessive heat and direct sun

OTC - QUESTIONS SECTION

Questions or comments? Call toll free 1-800-535-5053

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tropical SunscreenTropical Sunscreen

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130610012344612GTIN-13: 0610012344612
EAN-13: 0610012344612
GTIN-12: 610012344612
UPC-A: 610012344612
GTIN storage (14 digits): 00610012344612		Tropical_Ice Cream Sunscreen.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-004-062024-08-22C16284748780-11030e365-6919-111a-e063-dadaa90a10e2Tropical scented SPF30 BROAD SPECTRUM LOTION FORMULA #2000-DL-CL30V Oxybenzone free/Octinoxate free
58418-004-062024-07-30C16284748780-11030e365-6919-111a-e063-dadaa90a10e2Tropical scented SPF30 BROAD SPECTRUM LOTION FORMULA #2000-DL-CL30V Oxybenzone free/Octinoxate free
58418-004-062024-01-30C16284748780-11030e365-6919-111a-e063-dadaa90a10e2Tropical scented SPF30 BROAD SPECTRUM LOTION FORMULA #2000-DL-CL30V Oxybenzone free/Octinoxate free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-004-062000DL-CL30T177 mL in 1 TUBELOTION1775

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58418-00458418-004-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ETHYLHEXYLGLYCERIN147D247K3PIACT
WATER059QF0KO0RIACT
Octocrylene5A68WGF6WMACTIB
AVOBENZONEG63QQF2NOXACTIB
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
SORBETH-12 HEXAOLEATEF3ECF77W74IACT
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMERTY3J98ZR7RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
FRAGRANCE 135765EM498GW35IACT

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
2000DL-CL30TSPF30 BS TROPICALEpic Laboratories, LLC0286f94e-a2e8-b529-e063-6294a90ac08d2026-03-02WarningsExact identifier
ndc (package): 58418-004-06
ndc (product): 58418-004
ndc11 (package): 58418000406
spl id: 4c12935a-a071-488e-e063-6394a90aa6d3
spl set id: 0286f94e-a2e8-b529-e063-6294a90ac08d

Reported adverse events (FAERS/openFDA)#

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