FDA.reportPublic FDA data

Spf30 Sunscreen lotion (non broad spectrum)

Manufacturer
Tropical Enterprises International, Inc.
Effective date
2014-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:37

Label at a glance#

ProductSkin Crave spf30 sunscreen
Active ingredientOctisalate, Oxybenzone, Octocrylene, Octinoxate
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 immedaitely after towel dry9ing.

For use on children under 6 months: consult a physician

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Acrylic Polymer, Diazolidinyl Urea, Disodium EDTA, Hypromellose, Methylparaben, Propylene Glycol, Propylparaben, PPG-15 Stearyl Ether Benzoate, Triethanolamine, Water

INDICATIONS & USAGE SECTION

Uses: Helps prevent sunburn.

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

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients:

Octocrylene 7%, Octinoxate 6.5%

Oxybenone 5.5 %, Octisalate 4%

WARNINGS SECTION

WARNINGS: Skin Cancer/ Sking 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. Do not use on damaged or broken skin.

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 or persists.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLPDNPLPDN

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-223-012020-01-31C16284748780-19d75b9cf-fea5-f424-e053-dadaa90a57ceSpf30 Sunscreen lotion (non broad spectrum)
58418-223-022020-01-31C16284748780-19d75b9cf-fea5-f424-e053-dadaa90a57ceSpf30 Sunscreen lotion (non broad spectrum)
58418-223-042020-01-31C16284748780-19d75b9cf-fea5-f424-e053-dadaa90a57ceSpf30 Sunscreen lotion (non broad spectrum)
58418-223-082020-01-31C16284748780-19d75b9cf-fea5-f424-e053-dadaa90a57ceSpf30 Sunscreen lotion (non broad spectrum)
58418-223-102020-01-31C16284748780-19d75b9cf-fea5-f424-e053-dadaa90a57ceSpf30 Sunscreen lotion (non broad spectrum)
58418-223-122020-01-31C16284748780-19d75b9cf-fea5-f424-e053-dadaa90a57ceSpf30 Sunscreen lotion (non broad spectrum)
58418-223-162020-01-31C16284748780-19d75b9cf-fea5-f424-e053-dadaa90a57ceSpf30 Sunscreen lotion (non broad spectrum)
58418-223-282020-01-31C16284748780-19d75b9cf-fea5-f424-e053-dadaa90a57ceSpf30 Sunscreen lotion (non broad spectrum)
58418-223-642020-01-31C16284748780-19d75b9cf-fea5-f424-e053-dadaa90a57ceSpf30 Sunscreen lotion (non broad spectrum)
58418-223-802020-01-31C16284748780-19d75b9cf-fea5-f424-e053-dadaa90a57ceSpf30 Sunscreen lotion (non broad spectrum)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-223-01Skin Crave spf30 sunscreen30 mL in 1 BOTTLELOTION301
58418-223-02Skin Crave spf30 sunscreen60 mL in 1 BOTTLELOTION601
58418-223-04Skin Crave spf30 sunscreen120 mL in 1 BOTTLELOTION1201
58418-223-08Skin Crave spf30 sunscreen240 mL in 1 BOTTLELOTION2401
58418-223-10Skin Crave spf30 sunscreen10 mL in 1 BOTTLE, SPRAYLOTION101
58418-223-12Skin Crave spf30 sunscreen360 mL in 1 BOTTLE, PUMPLOTION3601
58418-223-16Skin Crave spf30 sunscreen480 mL in 1 BOTTLE, PUMPLOTION4801
58418-223-28Skin Crave spf30 sunscreen3840 mL in 1 BOTTLE, PUMPLOTION38401
58418-223-64Skin Crave spf30 sunscreen1920 mL in 1 BOTTLE, PUMPLOTION19201
58418-223-80Skin Crave spf30 sunscreen240 mL in 1 BOTTLE, PUMPLOTION2401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-223SKIN CRAVE SPF30 SUNSCREEN (SPF30 SUNSCREEN LOTION (NON-BROAD SPECTRUM)) LOTION [TROPICAL ENTERPRISES INTERNATIONAL, INC.]1Legacy NDC, 10 package rows20170420_092bafd9-8c27-56df-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58418-22358418-223-10, 58418-223-01, 58418-223-02, 58418-223-04, 58418-223-08, 58418-223-80, 58418-223-12, 58418-223-16, 58418-223-64, 58418-223-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Octisalate4X49Y0596WACTIB
Oxybenzone95OOS7VE0YACTIB
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
Octocrylene5A68WGF6WMACTIB
Octinoxate4Y5P7MUD51ACTIB
MAGNESIUM DISODIUM EDTANDT563S5VZIACT
HYPROMELLOSE 2208 (100 MPA.S)B1QE5P712KIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
PPG-15 STEARYL ETHER BENZOATE80D2J6361MIACT
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
092bafd9-8c28-56df-e054-00144ff88e88092bafd9-8c27-56df-e054-00144ff88e882014-12-01WarningsExact identifier
spl id: 092bafd9-8c28-56df-e054-00144ff88e88
spl set id: 092bafd9-8c27-56df-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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