FDA.reportPublic FDA data

Ultra Balm Moisturizing Protective Balm for lips SPF 20 Cerise Brise

Manufacturer
BEL STAR S A
Effective date
2025-06-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:03:32

Label at a glance#

ProductUltra Balm Moisturizing Protective Balm for lips SPF 20 Coral Petale
Active ingredientZINC OXIDE, OCTINOXATE
Label structure13 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 ifrash occurs.

WARNINGS SECTION

Warnings

  • 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 useon damaged or broken skin.
  • When using this productkeep 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

OTHER SAFETY INFORMATION

Other Information

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

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.

Ultra Balm SPF 20 Nude Translucide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Ultra Balm SPF 20 Coral Petal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Ultra Balm SPF 20 Rose Paradise

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Ultra Balm SPF 20 Rose Cotton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Ultra Balm SPF 20 Cerise Brise

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
14141-452-01Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude Translucide4 g in 1 CARTONSTICK44
14141-453-01Ultra Balm Moisturizing Protective Balm for lips SPF 20 Coral Petale4 g in 1 CARTONSTICK44
14141-454-01Ultra Balm Moisturizing Protective Balm for lips SPF 20 Rose Cotton4 g in 1 CARTONSTICK44
14141-455-01Ultra Balm Moisturizing Protective Balm for lips SPF 20 Rose Paradise4 g in 1 CARTONSTICK44
14141-456-01Ultra Balm Moisturizing Protective Balm for lips SPF 20 Cerise Brise4 g in 1 CARTONSTICK44

Products#

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

DailyMed product names page 1 of 2 · 41 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-45214141-452-01
14141-45314141-453-01
14141-45414141-454-01
14141-45514141-455-01
14141-45614141-456-01

Ingredients#

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

DailyMed ingredient rows page 1 of 5 · 175 matching rows.

Name, UNII, Kind table
NameUNIIKind
BRAZILIAN PEPPERSUG822G7CDIACT
CHLORPHENESINI670DAL4SZIACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEVLW429K27KIACT
OCTYLDODECANOL461N1O614YIACT
CARNAUBA WAXR12CBM0EIZIACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 1.5)V2W71V8T0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HELIANTHUS ANNUUS SEED WAX42DG15CHXVIACT
HEXYL LAURATE4CG9F9W01QIACT
ACACIA DECURRENS FLOWER WAXAU6XZE9IY9IACT
ETHYLHEXYL PALMITATE2865993309IACT
DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE554N82UWVWIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
CERESINQ1LS2UJO3AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
POLYGLYCERIN-34A0NCJ6RD6IACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIDECYL STEARATEA8OE252M6LIACT
DIMETHICONE92RU3N3Y1OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
CERAMIDE NP4370DF050BIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
MAGNESIUM POTASSIUM ALUMINOSILICATE FLUORIDEYK3DC63Y5MIACT
FERRIC OXIDE RED1K09F3G675IACT
TALC7SEV7J4R1UIACT
ZINC OXIDESOI2LOH54ZACTIB
OCTINOXATE4Y5P7MUD51ACTIB
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
BRAZILIAN PEPPERSUG822G7CDIACT
CHLORPHENESINI670DAL4SZIACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEVLW429K27KIACT

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
Ultra Balm Moisturizing Protective Balm for lips SPF 20 Nude TranslucideOCTINOXATE, ZINC OXIDEBEL STAR S Ac4d56723-3953-fb8e-e053-2a95a90a69d32025-06-19WarningsExact identifier
ndc (package): 14141-454-01
ndc (package): 14141-452-01
ndc (package): 14141-456-01
ndc (package): 14141-455-01
ndc (package): 14141-453-01
ndc (product): 14141-456
ndc (product): 14141-455
ndc (product): 14141-452
ndc (product): 14141-454
ndc (product): 14141-453
ndc11 (package): 14141045301
ndc11 (package): 14141045201
ndc11 (package): 14141045501
ndc11 (package): 14141045601
ndc11 (package): 14141045401
spl id: 37ef982d-5c8a-cda0-e063-6394a90a8c18
spl set id: c4d56723-3953-fb8e-e053-2a95a90a69d3

Reported adverse events (FAERS/openFDA)#

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