2000DL-CL30V

Manufacturer
Tropical Enterprises International, Inc.
Effective date
2024-01-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:31

Label at a glance#

Product2000DL-CL30V
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.

Keep out of reach of children.

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

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

Other 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

Vanilla spf30Vanilla spf30

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-005-062024-07-30C16284748780-11e7a6dab-1b5f-a2ce-e063-dadaa90aadf7Ice Cream Sunscreen - chocolate FORMULA #2000-DL-CL30V Oxybenzone free/Octinoxate free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-005-062000DL-CL30V177 mL in 1 TUBELOTION1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-0052000DL-CL30V (SPF30 BS CHOCOLATE) LOTION [TROPICAL ENTERPRISES INTERNATIONAL, INC.]11 package rows20240516_187597ff-59ea-dcf5-e063-6394a90acbbf.zip

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
58418-00558418-005-06

Ingredients#

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

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

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
18759827-df10-84e2-e063-6294a90a0bbc187597ff-59ea-dcf5-e063-6394a90acbbf2024-01-01WarningsExact identifier
spl id: 18759827-df10-84e2-e063-6294a90a0bbc
spl set id: 187597ff-59ea-dcf5-e063-6394a90acbbf

Reported adverse events (FAERS/openFDA)#

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