FDA.reportPublic FDA data

RR SPF30 Sun Stick

Manufacturer
Tropical Enterprises International, Inc | Tropical Enterprises International, Inc.
Effective date
2020-02-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:03:36

Label at a glance#

ProductRR SPF30 Sun Stick
Active ingredientOCTISALATE, OCTOCRYLENE, OXYBENZONE, HOMOSALATE, AVOBENZONE
Label structure7 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 7.5%

Octisalate 5%

Octocrylene 2.5%

Oxybenzone 6%

INSTRUCTIONS FOR USE SECTION

Uses - Helps prevent sunburn

WARNINGS SECTION

  • For external use only
  • Do not use on damaged or broken skin
  • Stop use and ask a doctor if rash occurs
  • When using this product keep out of eyes. Rinse with water to remove.
  • Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

INSTRUCTIONS FOR USE SECTION

Directions:

Apply liberally 15 minutes before sun exposure

  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • children under 6 months of age: Ask a Doctor

Sun Protection Measures: 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 - 2pm.
  • wear long sleeved shirts, pants, hats and sunglasses

INACTIVE INGREDIENT SECTION

Beeswax, cetyl alcohol, cocoa butter, coconut oil, dimethicone, jojoba oil, ozokerite wax, rosemary extract, vitamin E

OTHER SAFETY INFORMATION

Other Information:

Protect this product from excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BSSPF30SUNSTICKBSSPF30SUNSTICK

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-276-052022-01-28C16284748780-19d75b9d0-63d6-f424-e053-dadaa90a57ceRaining_Broad Spectrum Spf30 Sunstick 276
58418-276-052020-02-03C16284748780-19d75b9d0-63d6-f424-e053-dadaa90a57ceRaining_Broad Spectrum Spf30 Sunstick 276
58418-276-052020-01-31C16284748780-19d75b9d0-63d6-f424-e053-dadaa90a57ceRaining_Broad Spectrum Spf30 Sunstick 276

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-276-05RR SPF30 Sun Stick15 mL in 1 CANISTERSTICK152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-276RR SPF30 SUN STICK (SPF30 SUN STICK) STICK [TROPICAL ENTERPRISES INTERNATIONAL, INC]2Legacy NDC, 1 package rows20200204_7496c1a5-c31b-10c0-e053-2991aa0aa359.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58418-27658418-276-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
OCTISALATE4X49Y0596WACTIB
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
COCOA BUTTER512OYT1CRRIACT
HOMOSALATEV06SV4M95SACTIB
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
JOJOBA OIL724GKU717MIACT
CETYL ALCOHOL936JST6JCNIACT
AVOBENZONEG63QQF2NOXACTIB
COCONUT OILQ9L0O73W7LIACT
CERESINQ1LS2UJO3AIACT
ROSEMARYIJ67X351P9IACT

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
9da4bf1e-24bc-59a2-e053-2a95a90a39677496c1a5-c31b-10c0-e053-2991aa0aa3592020-02-02WarningsExact identifier
spl id: 9da4bf1e-24bc-59a2-e053-2a95a90a3967
spl set id: 7496c1a5-c31b-10c0-e053-2991aa0aa359

Reported adverse events (FAERS/openFDA)#

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