FDA.reportPublic FDA data

Tropical Sunscreen Lotion

Manufacturer
LS Promotions Inc
Effective date
2021-05-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:40:42

Label at a glance#

ProductTropical Sunscreen
Active ingredientOXYBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure14 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours Use a water resistant suncscreen if swimming or sweating Children under 6 months of age: Ask a Doctor

Label contents#

Full prescribing information#

Drug Facts

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0%

Homosalate 7.5%

Octisalate 5.0%

Octocrylene 2.5%

Oxybenzone 6.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warnings

WARNINGS SECTION

For external used only

Do not Use on Damaged or Broken Skin

Stop Use and Ask a Doctor

OTC - STOP USE SECTION

if rash occurs

When using this product

OTC - WHEN USING SECTION

Keep out of eyes.

Rinse with water to remove.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

INSTRUCTIONS FOR USE SECTION

  • Apply liberally 15 minutes before sun exposure
  • Reapply at least every 2 hours
  • Use a water resistant suncscreen if swimming or sweating
  • Children under 6 months of age: Ask a Doctor

Sun Protection Measures

USER SAFETY WARNINGS SECTION

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10am to 2pm. Wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Leaf Juice, Cetearyl Alcohol, Cetearyl Glucoside,

Citric Acid, Fragrance, Glycerin, Glyceryl Stearate SE, Grapeseed Oil, Methylparaben,

Potassium Sorbate, Propylparaben, Sunflower Oil, Sweet Almond Oil, Tocopherol,

Water, Xanthan Gum.

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Call weekdays from 9AM to 5PM EST

at 631-231-2300

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ST130 Tropical Sunscreen SPF30_1 fl oz_ART.jpgST130 Tropical Sunscreen SPF30_1 fl oz_ART.jpgLK1430 Tropical Sunscreen SPF30

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72449-086-012023-01-30C16284748780-1f386c649-fb49-0266-e053-dadaa90a7c1aTropical Sunscreen Lotion
72449-086-022023-01-30C16284748780-1f386c649-fb49-0266-e053-dadaa90a7c1aTropical Sunscreen Lotion
72449-086-032023-01-30C16284748780-1f386c649-fb49-0266-e053-dadaa90a7c1aTropical Sunscreen Lotion
72449-086-042023-01-30C16284748780-1f386c649-fb49-0266-e053-dadaa90a7c1aTropical Sunscreen Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72449-086-01Tropical Sunscreen3 mL in 1 PACKETLOTION31
72449-086-02Tropical Sunscreen59 mL in 1 BOTTLE, PLASTICLOTION591
72449-086-03Tropical Sunscreen29.5 mL in 1 BOTTLE, PLASTICLOTION29.51
72449-086-04Tropical Sunscreen5.9 mL in 1 PACKETLOTION5.91

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72449-086TROPICAL SUNSCREEN LOTION [LS PROMOTIONS INC]1Legacy NDC, 4 package rows20210604_c32e790c-1369-1dcc-e053-2995a90ab602.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72449-08672449-086-02, 72449-086-01, 72449-086-03, 72449-086-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
OXYBENZONE95OOS7VE0YACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
TOCOPHEROLR0ZB2556P8IACT
GLYCERINPDC6A3C0OXIACT
GRAPE SEED OIL930MLC8XGGIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
ALOE VERA LEAFZY81Z83H0XIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
OCTISALATE4X49Y0596WACTIB
WATER059QF0KO0RIACT
XANTHAN GUMTTV12P4NEEIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLPARABENZ8IX2SC1OHIACT
SUNFLOWER OIL3W1JG795YIIACT
ALMOND OIL66YXD4DKO9IACT
CETYL ALCOHOL936JST6JCNIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
FRAGRANCE FLORAL ORC0902236R66Z4YW3X0IACT
METHYLPARABENA2I8C7HI9TIACT
AVOBENZONEG63QQF2NOXACTIB

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
c32e790c-136a-1dcc-e053-2995a90ab602c32e790c-1369-1dcc-e053-2995a90ab6022021-05-25WarningsExact identifier
spl id: c32e790c-136a-1dcc-e053-2995a90ab602
spl set id: c32e790c-1369-1dcc-e053-2995a90ab602

Reported adverse events (FAERS/openFDA)#

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