2000DL-CL30
- Manufacturer
- Tropical Enterprises International, Inc.
- Effective date
- 2024-04-15
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 7
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:02:47
Label at a glance#
Product2000DL-CL30
Active ingredientOctocrylene, AVOBENZONE
Label structure10 sections
Contacts and useful links#
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
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: 1-877-773-9800
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
FDA-Initiated Inactive NDC Indexing#
Products#
Every source-derived product name is available through these pages.
- 2000DL-CL30
- promo spf30
- WATER
- Octocrylene
- AVOBENZONE
- EDETATE DISODIUM ANHYDROUS
- SORBETH-12 HEXAOLEATE
- BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER
- PHENOXYETHANOL
- ETHYLHEXYLGLYCERIN
- CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)
- STEARIC ACID
- TROLAMINE
- GLYCERYL MONOSTEARATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58418-002 | 58418-002-10, 58418-002-01, 58418-002-02, 58418-002-04, 58418-002-08, 58418-002-80, 58418-002-12, 58418-002-16, 58418-002-64, 58418-002-28, 58418-002-00, 58418-002-70, 58418-002-32, 58418-002-15, 58418-002-18, 58418-002-55, 58418-002-25, 58418-002-06 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 162d1bae-d10d-cc69-e063-6394a90a9bfa | 70ace275-b7cb-cc9c-e053-2991aa0af1bd | 2024-04-15 | Warnings | 162d1bae-d10d-cc69-e063-6394a90a9bfa 70ace275-b7cb-cc9c-e053-2991aa0af1bd |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.