FDA.reportPublic FDA data

Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm

Manufacturer
CoreTex Products, INC | Raining Rose
Effective date
2019-11-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:01:40

Label at a glance#

ProductSun XSPF 30 Broad Spectrum Sunscreen Lip Balm
Active ingredientOCTISALATE, OCTOCRYLENE, OXYBENZONE, AVOBENZONE, HOMOSALATE
Label structure13 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

apply liberally 15 minutes before sun exposure Use water resistant sunscreen if swimming or sweating Reapply at least every 2 hours Children under 6 months of age: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone…3.0%

Homosalate…7.5%

Octisalate…5.0%

Octocrylene…2.5%

Oxybenzone…6.0%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS SECTION

  • For external use only

OTC - DO NOT USE SECTION

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 to remove.

Keep out of reach of children

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally 15 minutes before sun exposure
  • Use 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

GENERAL PRECAUTIONS SECTION

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:

  • limit time in the sun, especially from 10a.m.-2p.m.
  • wear long sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Beeswax, castor oil, cocoa butter, coconut oil, shea utter

Other Information

OTHER SAFETY INFORMATION

Protect this productfrom excessive heat and direct sun.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coretex lip balmCoretex lip balm

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65753-105-232023-01-30C16284748780-1f386c64a-0fc8-0266-e053-dadaa90a7c1aSun X Lip Balm
65753-105-362023-01-30C16284748780-1f386c64a-0fc8-0266-e053-dadaa90a7c1aSun X Lip Balm
65753-105-382023-01-30C16284748780-1f386c64a-0fc8-0266-e053-dadaa90a7c1aSun X Lip Balm

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65753-105-23Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm4.44 mL in 1 APPLICATORLIPSTICK4.443
65753-105-23Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm50 in 1 CONTAINERLIPSTICK503
65753-105-36Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm24 in 1 CONTAINERLIPSTICK243
65753-105-36Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm4.44 mL in 1 APPLICATORLIPSTICK4.443
65753-105-38Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm72 in 1 CONTAINERLIPSTICK723
65753-105-38Sun XSPF 30 Broad Spectrum Sunscreen Lip Balm4.44 mL in 1 APPLICATORLIPSTICK4.443

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65753-105SUN XSPF 30 BROAD SPECTRUM SUNSCREEN LIP BALM (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LIPSTICK [CORETEX PRODUCTS, INC]3Legacy NDC, 6 package rows20191126_5f0b530a-d4a7-cd6f-e053-2991aa0a1d03.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65753-10565753-105-36, 65753-105-23, 65753-105-38

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
COCONUT OILQ9L0O73W7LIACT
WHITE WAX7G1J5DA97FIACT
SHEA BUTTERK49155WL9YIACT
COCOA BUTTER512OYT1CRRIACT

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
983350fa-921a-265c-e053-2995a90aea0e5f0b530a-d4a7-cd6f-e053-2991aa0a1d032019-11-25WarningsExact identifier
spl id: 983350fa-921a-265c-e053-2995a90aea0e
spl set id: 5f0b530a-d4a7-cd6f-e053-2991aa0a1d03

Reported adverse events (FAERS/openFDA)#

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