FDA.reportPublic FDA data

Skin Crave spf15 lip balm

Manufacturer
Tropical Enterprises International, Inc. | Raining Rose
Effective date
2018-07-11
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:56:13

Label at a glance#

ProductSkin Crave spf15 lip balm
Active ingredientOCTOCRYLENE, OCTISALATE, AVOBENZONE, OCTINOXATE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients: Purpose: Sunscreen

Avobenzone (2.0%)

Octinoxate (6.5%)

Octisalate (5.0%)

Octocrylene (1.5%)

OTC - PURPOSE SECTION

Purpose: Sunscreen

INDICATIONS & USAGE SECTION

Uses: Helps prevent sunburn

WARNINGS SECTION

Warnings:

  • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early aging. Thois product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
  • For external use only
  • Do not use on damaged or broken skin.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

  • When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • 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.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Sunflower oil, beeswax, extra virgin olive oil, flavor, hemp seed oil, rosemaruy extract, vitamin E, aloe vera

OTHER SAFETY INFORMATION

Other Information: Protect this product from excessive heat and direct sun.

OTC - QUESTIONS SECTION

Questions or Comments? 1-877-773-9800

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PLPDPLPD

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58418-295-152022-01-28C16284748780-1d6a99b39-9d10-a426-e053-dadaa90af4c2spf15 lip balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58418-295-15Skin Crave spf15 lip balm15 mL in 1 CANISTERLIPSTICK153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58418-295SKIN CRAVE SPF15 LIP BALM (SPF15 LIP BALM (CHEMICAL)) LIPSTICK [TROPICAL ENTERPRISES INTERNATIONAL, INC.]3Legacy NDC, 1 package rows20180711_484dcd16-27c2-1113-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58418-29558418-295-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
SUNFLOWER OIL3W1JG795YIIACT

Source Document#

Source XML · Source PDF

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
70bbafcd-0992-71b9-e053-2991aa0a2422484dcd16-27c2-1113-e054-00144ff8d46c2018-07-11WarningsExact identifier
spl id: 70bbafcd-0992-71b9-e053-2991aa0a2422
spl set id: 484dcd16-27c2-1113-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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