SS-TMPFL- bs spf30 spray - dl spray 
Tropical Enterprises International, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SPF30 BROAD SPECTRUM SPRAY
FORMULA #SS-TMPFL

DOSAGE AND ADMINISTRATION

Directions: Apply liberally and evenly 15 minutes before sun exposure. Reapply after 80 minutes of swimming or sweating, immediately after towel drying, AND at least every 2 hours.

Inactive Ingredients: Alcohol Denatured, Sorbeth-2 Hexaoleate, Acrylates/, Octylacrylamide Copolymer

Other Information:

Protect product from excessive heat and direct sun.

Keep out of reach of children. If product is swallowed seek immediate medical attention or contact a Poison Control Center right away.

Purpose: Sunscreen

WARNINGS: Skin Cancer/Skin 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 avoid contact with eyes. If contact with eyes occurs, flush with water to remove.

Stop use and ask a doctor if irritation or rash develops and persists.

Active Ingredients

Avobenzone 3%

Octocrylene 8%

Questions? Call

30ml

SS-TMPFL 
bs spf30 spray - dl spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58418-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.98 g  in 30 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE0.7425 g  in 30 mL
Inactive Ingredients
Ingredient NameStrength
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)  
SORBETH-12 HEXAOLEATE (UNII: F3ECF77W74)  
ALCOHOL (UNII: 3K9958V90M)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58418-001-1010 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product10/01/2018
2NDC:58418-001-0130 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/01/2018
3NDC:58418-001-0260 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/01/2018
4NDC:58418-001-04120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/01/2018
5NDC:58418-001-12360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
6NDC:58418-001-08240 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product10/01/2018
7NDC:58418-001-16480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
8NDC:58418-001-641920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
9NDC:58418-001-283840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/01/2018
10NDC:58418-001-70211200 mL in 1 DRUM; Type 0: Not a Combination Product10/01/2018
11NDC:58418-001-321228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product10/01/2018
12NDC:58418-001-25960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product04/24/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/01/2018
Labeler - Tropical Enterprises International, Inc. (091986179)
Registrant - Tropical Enterprises International, Inc. (091986179)
Establishment
NameAddressID/FEIBusiness Operations
Tropiical Enterprises International, Inc.091986179manufacture(58418-001) , label(58418-001) , pack(58418-001)

Revised: 3/2020
Document Id: a05e42d9-4842-6b2a-e053-2995a90a7b12
Set id: 70ac6e5f-2fca-733a-e053-2a91aa0aaf5b
Version: 3
Effective Time: 20200308
 
Tropical Enterprises International, Inc.