FDA.reportPublic FDA data

Skin Crave Broad Spectrum spf30

Manufacturer
Tropical Enterprises International Inc
Effective date
2014-12-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:56

Label at a glance#

ProductSkin Crave Broad Spectrum spf30
Active ingredientAVOBENZONE, OCTOCRYLENE, HOMOSALATE, OCTISALATE, OXYBENZONE
Label structure8 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Directions: Apply liberally and evenly 15 minutes before sun exposure.

Reapply every 2 hours as needed, after 40 minutes of swimming or sweating, or immediately after towel drying.

INACTIVE INGREDIENT SECTION

Inactive Ingredients:

Water, Polyester-7, Neopentyl Glycol Diheptanoate, Triethanolamine, Hypromellose, Acrylic Polymer, Propylene Glycol, Diazolidinyl Urea, Methylparaben, Propylparaben, Disodium EDTA

INDICATIONS & USAGE SECTION

Uses: Helps prevent sunburn. If used as direted with other sun protection measures, decreases the risk of skin cancer and eraly aging caused by the 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:

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.

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

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Octocrylene 10%

Homosalate 10%

Oxybenzone 6%

Octisalate 5%

Avobenzone 3%

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLPDPPLPDP

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-224-012020-01-31C16284748780-19d75b9d0-2a01-f424-e053-dadaa90a57ceSpf 30 Broad Spectrum Sunscreen - water based
58418-224-022020-01-31C16284748780-19d75b9d0-2a01-f424-e053-dadaa90a57ceSpf 30 Broad Spectrum Sunscreen - water based
58418-224-042020-01-31C16284748780-19d75b9d0-2a01-f424-e053-dadaa90a57ceSpf 30 Broad Spectrum Sunscreen - water based
58418-224-082020-01-31C16284748780-19d75b9d0-2a01-f424-e053-dadaa90a57ceSpf 30 Broad Spectrum Sunscreen - water based
58418-224-102020-01-31C16284748780-19d75b9d0-2a01-f424-e053-dadaa90a57ceSpf 30 Broad Spectrum Sunscreen - water based
58418-224-122020-01-31C16284748780-19d75b9d0-2a01-f424-e053-dadaa90a57ceSpf 30 Broad Spectrum Sunscreen - water based
58418-224-282020-01-31C16284748780-19d75b9d0-2a01-f424-e053-dadaa90a57ceSpf 30 Broad Spectrum Sunscreen - water based
58418-224-642020-01-31C16284748780-19d75b9d0-2a01-f424-e053-dadaa90a57ceSpf 30 Broad Spectrum Sunscreen - water based

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-224-01Skin Crave Broad Spectrum spf3030 mL in 1 BOTTLELOTION301
58418-224-02Skin Crave Broad Spectrum spf3060 mL in 1 BOTTLELOTION601
58418-224-04Skin Crave Broad Spectrum spf30120 mL in 1 BOTTLELOTION1201
58418-224-08Skin Crave Broad Spectrum spf30240 mL in 1 BOTTLE, PUMPLOTION2401
58418-224-10Skin Crave Broad Spectrum spf3010 mL in 1 BOTTLELOTION101
58418-224-12Skin Crave Broad Spectrum spf30360 mL in 1 BOTTLE, PUMPLOTION3601
58418-224-28Skin Crave Broad Spectrum spf303840 mL in 1 BOTTLE, PUMPLOTION38401
58418-224-64Skin Crave Broad Spectrum spf301920 mL in 1 BOTTLE, PUMPLOTION19201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-224SKIN CRAVE BROAD SPECTRUM SPF30 (SPF30 BROAD SPECTRUM SUNSCREEN LOTION) LOTION [TROPICAL ENTERPRISES INTERNATIONAL INC]1Legacy NDC, 8 package rows20170525_097c571a-e7bd-0e01-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58418-22458418-224-10, 58418-224-01, 58418-224-02, 58418-224-04, 58418-224-12, 58418-224-64, 58418-224-28, 58418-224-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTOCRYLENE5A68WGF6WMACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
POLYESTER-70841698D2FIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT
CUPRIC TRIETHANOLAMINE6NU949U74EIACT

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
097c571a-e7be-0e01-e054-00144ff8d46c097c571a-e7bd-0e01-e054-00144ff8d46c2014-12-05WarningsExact identifier
spl id: 097c571a-e7be-0e01-e054-00144ff8d46c
spl set id: 097c571a-e7bd-0e01-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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