Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Caramel

Manufacturer
Ventura Corporation LTD | BEL STAR S A
Effective date
2021-06-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:10

Label at a glance#

ProductUltra Balm Moisturizing Protective Balm for lips SPF 20 Nude Caramel
Active ingredientOCTINOXATE, ZINC OXIDE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Octinoxate 7.50% Sunscreen

Zinc Oxide 4.90% Sunscreen

OTC - PURPOSE SECTION

Uses

  • Helps prevent sunburn.

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.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs.

WARNINGS SECTION

Skin Cancer / Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This 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.
When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

Directions

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

INACTIVE INGREDIENT SECTION

Inactive ingredients: octyldodecanol, ethylhexyl palmitate, polyethylene, ozokerite, silica, jojoba esters, copernicia cerifera (carnauba) wax, cetyl peg/ppg-10/1 dimethicone, polyglyceryl-4 isostearate, helianthus annuus (sunflower) seed wax, hexyl laurate, tocopheryl acetate, dipentaerythrityl hexacaprylate/hexacaprate, tridecyl trimellitate, schinus terebinthifolia seed extract, phenoxyethanol, tridecyl stearate, dimethicone, acacia decurrens flower wax, polyglycerin-3, triethoxycaprylylsilane, neopentyl glycol dicaprylate/dicaprate, caprylyl glycol, chlorphenesin, trimethylsiloxysilicate, ceramide np, lecithin.
may contain:
mica, titanium dioxide, synthetic fluorphlogopite, iron oxides, yellow 5 lake, red 7 lake, red 6 lake, talc.

OTHER SAFETY INFORMATION

Other information

  • Protect the product in this container from excessive heat and direct sun

Ultra Balm SPF 20 Nude Caramel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

L'BEL

ULTRA BALM

Moisturizing protective balm for lips SPF 20 Nude Caramel

Net. Wt. 0.14 oz (4 g)

Nude CaramelNude Caramel

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43596-0890ULTRA BALM MOISTURIZING PROTECTIVE BALM FOR LIPS SPF 20 NUDE CARAMEL (OCTINOXATE, ZINC OXIDE) STICK [VENTURA CORPORATION LTD]1Legacy NDC20210701_c5fe42e2-0807-87ee-e053-2a95a90a02f1.zip

Products#

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

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43596-089043596-0890-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

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
42e123a8-fcb2-58e4-e063-6294a90ad752c5fe42e2-0807-87ee-e053-2a95a90a02f12025-11-05WarningsExact identifier
spl set id: c5fe42e2-0807-87ee-e053-2a95a90a02f1

Reported adverse events (FAERS/openFDA)#

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