2000DL-CL30T- spf30 bs tropical lotion 
Tropical Enterprises International, Inc.

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Tropical scented SPF30 BROAD SPECTRUM LOTION
FORMULA #2000-DL-CL30V
Oxybenzone free/Octinoxate free

Active Ingredients:

Avobenzone 3%

Octocrylene 8%

Purpose:

Sunscreen

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: 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. If product is swallowed, get immediate medical help or contact a Poison Control Center

right away.

Directions:

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

*at least every 2 hours

*children under 6 months: Ask a doctor

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 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.

*Protect product from excessive heat and direct sun

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

Tropical Sunscreen

2000DL-CL30T 
spf30 bs tropical lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.34 g  in 30 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.9 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
SORBETH-12 HEXAOLEATE (UNII: F3ECF77W74)  
BIS-OCTYLDODECYL DIMER DILINOLEATE/PROPANEDIOL COPOLYMER (UNII: TY3J98ZR7R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
FRAGRANCE 13576 (UNII: 5EM498GW35)  
Product Characteristics
Colorwhite (white to off-white) Score    
ShapeSize
FlavorTROPICAL FRUIT PUNCHImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58418-004-06177 mL in 1 TUBE; Type 0: Not a Combination Product10/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02010/01/2023
Labeler - Tropical Enterprises International, Inc. (091986179)
Registrant - Tropical Enterprises International, Inc. (091986179)
Establishment
NameAddressID/FEIBusiness Operations
Tropical Enterprises International, Inc.035229882manufacture(58418-004)

Revised: 1/2024
Document Id: 0e860102-a8a1-5dbd-e063-6394a90a69ff
Set id: 0286f94e-a2e8-b529-e063-6294a90ac08d
Version: 2
Effective Time: 20240109
 
Tropical Enterprises International, Inc.