SPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL

Manufacturer
Tropical Enterprises International, Inc. | Tropiical Enterprises International, Inc.
Effective date
2020-03-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:21:31

Label at a glance#

ProductSS-TMPFL
Active ingredientOCTOCRYLENE, AVOBENZONE
Label structure9 sections

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. 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.

Label contents#

Full prescribing information#

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

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.

80mn update

RECENT MAJOR CHANGES SECTION

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 INGREDIENT SECTION

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

OTHER SAFETY INFORMATION

Other Information:

Protect product from excessive heat and direct sun.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS SECTION

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.

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Avobenzone 3%

Octocrylene 8%

OTC - QUESTIONS SECTION

Questions? Call

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30ml30ml

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-001-012022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-022022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-042022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-082022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-102022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-122022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-162022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-252022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-282022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-322022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-642022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-702022-01-28C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-012020-02-03C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-022020-02-03C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-042020-02-03C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-082020-02-03C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-102020-02-03C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-122020-02-03C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-162020-02-03C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-282020-02-03C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-642020-02-03C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-012020-01-31C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-022020-01-31C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-042020-01-31C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-082020-01-31C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-102020-01-31C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-122020-01-31C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-162020-01-31C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-282020-01-31C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL
58418-001-642020-01-31C16284748780-19d75b9d0-3643-f424-e053-dadaa90a57ceSPF30 BROAD SPECTRUM SPRAY FORMULA #SS-TMPFL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-001-01SS-TMPFL30 mL in 1 BOTTLE, DISPENSINGSPRAY303
58418-001-02SS-TMPFL60 mL in 1 BOTTLE, DISPENSINGSPRAY603
58418-001-04SS-TMPFL120 mL in 1 BOTTLE, DISPENSINGSPRAY1203
58418-001-08SS-TMPFL240 mL in 1 BOTTLE, DISPENSINGSPRAY2403
58418-001-10SS-TMPFL10 mL in 1 BOTTLE, SPRAYSPRAY103
58418-001-12SS-TMPFL360 mL in 1 BOTTLE, PUMPSPRAY3603
58418-001-16SS-TMPFL480 mL in 1 BOTTLE, PUMPSPRAY4803
58418-001-25SS-TMPFL960000 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKSPRAY9600003
58418-001-28SS-TMPFL3840 mL in 1 BOTTLE, PUMPSPRAY38403
58418-001-32SS-TMPFL1228800 mL in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULKSPRAY12288003
58418-001-64SS-TMPFL1920 mL in 1 BOTTLE, PUMPSPRAY19203
58418-001-70SS-TMPFL211200 mL in 1 DRUMSPRAY2112003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-001SS-TMPFL (BS SPF30 SPRAY - DL) SPRAY [TROPICAL ENTERPRISES INTERNATIONAL, INC.]3Legacy NDC, 12 package rows20200716_70ac6e5f-2fca-733a-e053-2a91aa0aaf5b.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
a05e42d9-4842-6b2a-e053-2995a90a7b1270ac6e5f-2fca-733a-e053-2a91aa0aaf5b2020-03-08WarningsExact identifier
spl id: a05e42d9-4842-6b2a-e053-2995a90a7b12
spl set id: 70ac6e5f-2fca-733a-e053-2a91aa0aaf5b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.