2000DL-CL30T- spf30 bs tropical lotion

2000DL-CL30T by

Drug Labeling and Warnings

2000DL-CL30T by is a Otc medication manufactured, distributed, or labeled by Tropical Enterprises International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

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

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.

INDICATIONS & USAGE

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.

PURPOSE

Purpose:

Sunscreen

ACTIVE INGREDIENT

Active Ingredients:

Avobenzone 3%

Octocrylene 8%

WARNINGS

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.

OTHER SAFETY INFORMATION

*Protect product from excessive heat and direct sun

QUESTIONS

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

2000DL-CL30T 
spf30 bs tropical lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58418-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	2.34 g  in 30 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.9 g  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (white to off-white)	Score
Shape		Size
Flavor	TROPICAL FRUIT PUNCH	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58418-004-06	177 mL in 1 TUBE; Type 0: Not a Combination Product	10/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2023

Labeler - Tropical Enterprises International, Inc. (091986179)

Registrant - Tropical Enterprises International, Inc. (091986179)

Establishment
Name	Address	ID/FEI	Business Operations
Tropical Enterprises International, Inc.		091986179	manufacture(58418-004)