FDA.reportPublic FDA data

Fresh Mint Moisturizing Sunscreen Lip Balm SPF 15

Manufacturer
Tween Brands Inc
Effective date
2016-09-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:47:01

Label at a glance#

ProductFresh Mint Moisturizing Sunscreen Lip Balm SPF 15
Active ingredientOCTINOXATE
Label structure8 sections

Indications and uses

Helps prevent sunburn

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Ethylhexyl Methoxycinnamate 3.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn

Warning

WARNINGS SECTION

  • For external Use only
  • Do not use on damaged or broken skin.
  • When using this product keep out of eyes.
  • Rinse with water to remove.
  • Stop use and ask a doctor if rash occurs.

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed get medical help or contact a Poison Control Center in area.

Directions

INSTRUCTIONS FOR USE SECTION

  • Apply liberally 15 minutes before sun exposure.
  • Reapply at least every 2 hours.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Mineral Oil, Ozokerite, Ethylhexyl Palmitate, Polybutene, Cera alba, Synthetic wax, Butyrospermum Parkii (Shea) Butter, Aloe Barbadensis Extract, Fragrance, Tocopheryl acerare.

Fresh Mint Moisturizing Sunscreen Lip Balm SPF 15

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage descriptionimage descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60637-116-002020-01-31C16284748780-19d75b9d0-f268-f424-e053-dadaa90a57ceFresh Mint Moisturizing Sunscreen Lip Balm SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60637-116-00Fresh Mint Moisturizing Sunscreen Lip Balm SPF 151 in 1 BOXLIPSTICK11
60637-116-00Fresh Mint Moisturizing Sunscreen Lip Balm SPF 153.5 g in 1 BOTTLE, PLASTICLIPSTICK3.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60637-116FRESH MINT MOISTURIZING SUNSCREEN LIP BALM SPF 15 (ETHYLHEXYL METHOXYCINNAMATE) LIPSTICK [TWEEN BRANDS INC]1Legacy NDC, 2 package rows20160906_e0d1b2b5-9508-4cd8-95e6-6e5fe2aafac4.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60637-11660637-116-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
CERESINQ1LS2UJO3AIACT
ETHYLHEXYL PALMITATE2865993309IACT
SHEA BUTTERK49155WL9YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
MINERAL OILT5L8T28FGPIACT
OCTINOXATE4Y5P7MUD51ACTIB

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
3bdc32df-e42c-1c21-e054-00144ff88e88e0d1b2b5-9508-4cd8-95e6-6e5fe2aafac42016-09-06WarningsExact identifier
spl id: 3bdc32df-e42c-1c21-e054-00144ff88e88
spl set id: e0d1b2b5-9508-4cd8-95e6-6e5fe2aafac4

Reported adverse events (FAERS/openFDA)#

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