FDA.reportPublic FDA data

Intense Therapy Lip Balm Winter Melon

Manufacturer
Jack Black, LLC | Swiss-American CDMO, LLC
Effective date
2026-09-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-09-11 03:01:35

Label at a glance#

ProductIntense Therapy Lip Balm Winter Melon
Active ingredientAVOBENZONE, OCTINOXATE, PETROLATUM
Label structure9 sections

Indications and uses

Helps prevent sunburn and chapped lips.

Dosage and administration

Apply liberally and reapply every 2 hours or after eating, drinking, swimming or wiping lips.

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

Stop use and ask doctor if rash occurs

Children under 6 months: Ask a doctor

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3.0% Sunscreen

Octinoxate 7.5% Sunscreen

Petrolatum 40.2% Skin Protectant

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally and reapply every 2 hours or after eating, drinking, swimming or wiping lips.

Keep out of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of Reach of Children

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn and chapped lips.

Uses

OTC - PURPOSE SECTION

Helps prevent sunburn and chapped lips.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

beeswax, butyrospermum Parkii (shea) butter, C18-38 alkyl hydroxystearol stearate, camellia sinenesis (green tea) leaf extract, cyclohexasiloxane, cyclopentasiloxane, flavor, lanolin, microcrystalline wax, ozokerite, persea gratissima (avocado) oil, ployglyceryl 3 beeswax, theobroma cacao (cocoa) seed butter, tocopheryl acetate

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Winter Melon Lip Balm ArtworkWinter Melon Lip Balm Artwork

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66738-04866738-048-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
PETROLATUM4T6H12BN9UACTIB
COCOA BUTTER512OYT1CRRIACT
LANOLIN OILOVV5IIJ58FIACT
WHITE WAX7G1J5DA97FIACT
METHYL SALICYLATELAV5U5022YIACT
SHEA BUTTERK49155WL9YIACT
AVOCADO OIL6VNO72PFC1IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 6XHK3U310BAIACT
MICROCRYSTALLINE WAXXOF597Q3KYIACT
GREEN TEA LEAFW2ZU1RY8B0IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22023-11-08full-release2026-05-31 23:59:38

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
Intense Therapy Lip Balm Winter MelonSUNSCREEN SKIN PROTECTANT LIP BALMJack Black, LLCe7792b4e-a6d2-487e-ba28-27b68e6d7e272026-09-08WarningsExact identifier
ndc (package): 66738-048-25
ndc (product): 66738-048
ndc11 (package): 66738004825
spl id: 5aff718e-04c6-4e7b-e063-6294a90a82c5
spl set id: e7792b4e-a6d2-487e-ba28-27b68e6d7e27

Reported adverse events (FAERS/openFDA)#

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