FDA.reportPublic FDA data

TROPICSURF EXTREME PROTECTION SPF50

Manufacturer
PALMER SURF LLC (DBA X3EMBRANDS)
Effective date
2017-12-18
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-05-31 22:53:30

Label at a glance#

ProductTROPICSURF EXTREME PROTECTION SPF50
Active ingredientOCTOCRYLENE, ZINC OXIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENT

  • OCTOCRYLENE  7.5%
  • ZINC OXIDE      10.5%

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS

  • APPLY LIBERALLY 15 MINUTES PRIOR TO SUN EXPOSURE. REAPPLY AFTER
  • 80 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL
  • DRYING; AND, AT LEAST EVERY 2 HOURS.

SUN PROTECTION MEASURES:

  • SPENDING TIME IN THE SUN INCREASES YOUR RISKI 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 10 AM TO 2 PM; WEAR
  • LONG-SLEEVE SHIRTS, PANTS, HATS AND SUNGLASSES; CHILDREN UNDER 6 MOS.
  • OF AGE, ASK A DOCTOR

OTC - PURPOSE SECTION

PURPOSE:

  • SUNSCREEN

INDICATIONS & USAGE SECTION

Uses:

  • HELPS PREVENT SUNBURN
  • IF USED AS DIRECTED WITH OTHER SUN PROTECTION MEASURES (SEE DIRECTIONS),
  • DECREASES THE RISK OF SKIN CANCER AND EARLY SKIN AGING CAUSED BY THE SUN.

WARNINGS SECTION

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE ON DAMAGED OR BROKEN SKIN

OTC - WHEN USING SECTION

WHEN USING THIS PRODUCT

  • KEEP OUT OF THE EYES.
  • RINSE WITH WATER TO REMOVE

OTC - STOP USE SECTION

STOP USE AND ASK A DOCTOR IF

  • IF RASH OCCURS

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

  • IF PRODUCT IS SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS:

WATER/AQUA/EAU, OCTYLDODECYL NEOPENTANOATE, DIMETHICONE, CETEARYL ALCOHOL, ACRYLATES COPOLYMER,

PEG-100 STEARATE, GLYCERYL STEARATE, PENTYLENE GLYCOL, PHENYL TRIMETHICONE, GLYCERIN, CYCLOPENTASILOXANE,

TRIMETHYLSILOXYSILICATE, PEG-40 STEARATE, ALOE BARBADENSIS LEAF JUICE, CAMELLIA OLEIFERA LEAF JUICE,

ASTROCARYUM TUCUMA SEED BUTTER, MACADAMIA TERNIFOLIA SEED OIL, ADANSONIA DIGITATA SEED OIL, MANGIFERA

INDICA (MANGO) SEED BUTTER, COCO GLUCOSIDE, TOCOPHERYL ACETATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL

TAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, POLYSILICONE-11, SODIUM POLYACRYLATE, XANTHAN GUM,

DICETYL PHOSPHATE, CETTH-10 PHOSPHATE, AMINOMETHYLPROPANOL, DISODIUM EDTA, CAPRYLYL GLYCOL, PHENOXYETHANOL,

CHLOPHENESIN, BENXYL CINNAMATE, COUMARIN, LIMONENE, HEXYL CINNAMAL, FRAGRANCE (PARFUM)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SPF50SPF50

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70884-102-032020-01-31C16284748780-19d75b9d0-9b7a-f424-e053-dadaa90a57ce5f91b1c1-26be-45fc-90e9-d258f8326666
70884-102-112020-01-31C16284748780-19d75b9d0-9b7a-f424-e053-dadaa90a57ce5f91b1c1-26be-45fc-90e9-d258f8326666
70884-102-132020-01-31C16284748780-19d75b9d0-9b7a-f424-e053-dadaa90a57ce5f91b1c1-26be-45fc-90e9-d258f8326666
70884-102-162020-01-31C16284748780-19d75b9d0-9b7a-f424-e053-dadaa90a57ce5f91b1c1-26be-45fc-90e9-d258f8326666
70884-102-302020-01-31C16284748780-19d75b9d0-9b7a-f424-e053-dadaa90a57ce5f91b1c1-26be-45fc-90e9-d258f8326666

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70884-102-03TROPICSURF EXTREME PROTECTION SPF5090 mL in 1 BOTTLELOTION905
70884-102-11TROPICSURF EXTREME PROTECTION SPF5045 mL in 1 BOTTLELOTION455
70884-102-13TROPICSURF EXTREME PROTECTION SPF50390 mL in 1 BOTTLELOTION3905
70884-102-16TROPICSURF EXTREME PROTECTION SPF50195 mL in 1 BOTTLELOTION1955
70884-102-30TROPICSURF EXTREME PROTECTION SPF50960 mL in 1 BOTTLELOTION9605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70884-102TROPICSURF EXTREME PROTECTION SPF50 (OCTOCRYLENE, ZINC OXIDE) LOTION [PALMER SURF LLC (DBA X3EMBRANDS)]5Legacy NDC, 5 package rows20171218_5f91b1c1-26be-45fc-90e9-d258f8326666.zip

Products#

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

DailyMed product names page 1 of 2 · 43 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70884-10270884-102-11, 70884-102-03, 70884-102-16, 70884-102-13, 70884-102-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 40 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIM
WATER059QF0KO0RIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
DIMETHICONE92RU3N3Y1OIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
PENTYLENE GLYCOL50C1307PZGIACT
PHENYL TRIMETHICONEDR0K5NOJ4RIACT
GLYCERINPDC6A3C0OXIACT
CYCLOMETHICONE 50THT5PCI0RIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
PEG-40 STEARATEECU18C66Q7IACT
ALOE VERA LEAFZY81Z83H0XIACT
CAMELLIA OLEIFERA LEAF5077EL0C60IACT
ASTROCARYUM ACULEATUM SEED OILJUP28JPX3KIACT
MACADAMIA OIL515610SU8CIACT
ADANSONIA DIGITATA SEED OIL77MKL7AR5IIACT
MANGIFERA INDICA SEED BUTTER4OXD9M35X2IACT
COCO GLUCOSIDEICS790225BIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
SQUALANEGW89575KF9IACT
POLYSORBATE 60CAL22UVI4MIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
XANTHAN GUMTTV12P4NEEIACT
DIHEXADECYL PHOSPHATE2V6E5WN99NIACT
CETETH-10 PHOSPHATE4E05O5N49GIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
DISODIUM EDTA-COPPER6V475AX06UIACT
CAPRYLYL GLYCOL00YIU5438UIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CHLORPHENESINI670DAL4SZIACT
BENZYL CINNAMATEV67O3RO97UIACT
COUMARINA4VZ22K1WTIACT
LIMONENE, (+)-GFD7C86Q1WIACT
.ALPHA.-HEXYLCINNAMALDEHYDE7X6O37OK2IIACT

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
7d9cd804-b429-4a20-b4cd-be3b07900e4e5f91b1c1-26be-45fc-90e9-d258f83266662017-12-18WarningsExact identifier
spl id: 7d9cd804-b429-4a20-b4cd-be3b07900e4e
spl set id: 5f91b1c1-26be-45fc-90e9-d258f8326666

Reported adverse events (FAERS/openFDA)#

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