Active Ingredients And Purpose
OTC - ACTIVE INGREDIENT SECTION
Active Ingredients: Avobenzone 3% Octocrylene 8%
OTC - PURPOSE SECTION
Purpose: Sunscreen
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
Key Label Information#
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 : 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.
Directions And Dosage
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
Other Label Information
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.
OTC - QUESTIONS SECTION
Questions or comments? Call toll free 1-800-535-5053
Label Images#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 58418-005-06 | 2024-07-30 | C162847 | 48780-1 | 1e7a6dab-1b5f-a2ce-e063-dadaa90aadf7 | Ice Cream Sunscreen - chocolate FORMULA #2000-DL-CL30V Oxybenzone free/Octinoxate free |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 58418-005-06 | 2000DL-CL30V | 177 mL in 1 TUBE | LOTION | 177 | 1 |
DailyMed Dashboard NDC Coverage#
Products#
- 2000DL-CL30V
- SPF30 BS chocolate
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 58418-005 | 58418-005-06 |
Ingredients#
Complete SPL Sections#
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.
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