SS-TMPFL- bs spf30 spray - dl spray

SS-TMPFL by

Drug Labeling and Warnings

SS-TMPFL by is a Otc medication manufactured, distributed, or labeled by Tropical Enterprises International, Inc., Tropiical Enterprises International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE AND ADMINISTRATION

Directions: Apply liberally 15 minutes before sun exposure. Children under 6 monts: Ask a doctor. Reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every 2 hours.

INACTIVE INGREDIENT

Inactive Ingredients: Acrylic Polymer, Corn Starch Modified, Diazolidinyl Urea, Disodium EDTA, Hypromellose, Methylparaben, Propylene Glycol, Propyparaben, PPG-15 Stearyl Ether Benzoate, Triethanolamine, Water.

INDICATIONS & USAGE

Uses: Helps prevent sunburn.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed get medical help or contact a Poison Control Center right away.

PURPOSE

Purpose: Sunscreen

WARNINGS

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. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if irritation or rash occurs.

ACTIVE INGREDIENT

Active Ingredients

Octrinoxate 7%

Octisalate 3%

Oxybenzone 2%

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SS-TMPFL 
bs spf30 spray - dl spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 58418-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	8 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
CREATINE ETHYL ESTER (UNII: I3P1L0D47K)
HEPTANE (UNII: 456148SDMJ)
METHYL ISOBUTYL KETONE (UNII: U5T7B88CNP)
(1-CYANOCYCLOHEXYL)ACETIC ACID (UNII: E1393FZ76L)
ALCOHOL (UNII: 3K9958V90M)
METHYL ALCOHOL (UNII: Y4S76JWI15)
(DIBUTYLAMINO)METHANOL (UNII: 5I6MJ5HVZE)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 58418-001-10	10 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	10/01/2018
2	NDC: 58418-001-01	30 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/01/2018
3	NDC: 58418-001-02	60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/01/2018
4	NDC: 58418-001-04	120 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/01/2018
5	NDC: 58418-001-12	360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2018
6	NDC: 58418-001-08	240 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	10/01/2018
7	NDC: 58418-001-16	480 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2018
8	NDC: 58418-001-64	1920 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2018
9	NDC: 58418-001-28	3840 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	10/01/2018
10	NDC: 58418-001-70	211200 mL in 1 DRUM; Type 0: Not a Combination Product	10/01/2018
11	NDC: 58418-001-32	1228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK; Type 0: Not a Combination Product	10/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	10/01/2018

Labeler - Tropical Enterprises International, Inc. (091986179)

Registrant - Tropical Enterprises International, Inc. (091986179)

Establishment
Name	Address	ID/FEI	Business Operations
Tropiical Enterprises International, Inc.		091986179	manufacture(58418-001) , label(58418-001) , pack(58418-001)